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Prescription medicine · generic available

Gabapentin

Brand names: Neurontin, Gralise, Relgaabi, Gabarone

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

NoBoxed warning
None listedFDA shortage list
17Recalls (FDA reports)
82Companies
1993First FDA approval on file

Quick answers

What is Gabapentin used for?
The FDA-approved label (Neurontin, Viatris Specialty LLC, May 12, 2026) says: “NEURONTIN ® is indicated for: • Management of postherpetic neuralgia in adults • Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy NEURONTIN is indicated for …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Gabapentin have a boxed warning?
No. None of the 385 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Gabapentin?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Gabapentin been recalled?
FDA enforcement reports list 17 recalls of products of this medicine; the newest started October 10, 2025 (Class II). A recall usually concerns specific lots, not every product.
Who makes Gabapentin?
82 companies list prescription products of Gabapentin in the FDA NDC Directory, including Bryant Ranch Prepack, Proficient Rx LP and Aphena Pharma Solutions - Tennessee, LLC.

What Gabapentin is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

NEURONTIN ® is indicated for: • Management of postherpetic neuralgia in adults • Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy NEURONTIN is indicated for …

— FDA label: Neurontin, Viatris Specialty LLC, effective May 12, 2026. Read the full label on DailyMed →

The FDA has 385 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Epilepsy

Related medical specialties

Neurology

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 385 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsCapsule · Tablet · Tablet, film coated · Tablet, coated · Solution · Suspension
RouteOral
Prescription products580 in the FDA NDC Directory
Brand namesNeurontin, Gralise, Relgaabi, Gabarone

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Gabapentin, by strength and form
Strength and formGeneric or brandPharmacies pay
gabapentin 100 mg
capsule		 Generic $0.0219 per capsule
gabapentin 100 mg
capsule		 Brand: Neurontin $2.96 per capsule
gabapentin 100 mg
tablet		 Brand: Gabarone $8.79 per tablet
gabapentin 250 mg/5 mL
solution		 Generic $0.0839–$0.1712 per mL
7 packages, lowest to highest
gabapentin 250 mg/5 mL
suspension		 Generic $0.0839 per mL
gabapentin 300 mg
capsule		 Generic $0.0328 per capsule
gabapentin 300 mg
capsule		 Brand: Neurontin $7.36 per capsule
gabapentin 300 mg
tablet		 Generic $0.6227 per tablet
gabapentin 300 mg
tablet, film coated		 Generic $0.6227 per tablet
gabapentin 300 mg
tablet, film coated		 Brand: Gralise $10.20 per tablet
gabapentin 400 mg
capsule		 Generic $0.0428 per capsule
gabapentin 400 mg
capsule		 Brand: Neurontin $8.87 per capsule
gabapentin 400 mg
tablet		 Brand: Gabarone $8.21 per tablet
gabapentin 450 mg
tablet, film coated		 Brand: Gralise $10.14 per tablet
gabapentin 600 mg
tablet		 Generic $0.0639–$1.11 per tablet
21 packages, lowest to highest
gabapentin 600 mg
tablet, coated		 Generic $0.0639 per tablet
gabapentin 600 mg
tablet, film coated		 Generic $0.0639–$1.11 per tablet
15 packages, lowest to highest
gabapentin 600 mg
tablet, film coated		 Brand: Gralise $10.15 per tablet
gabapentin 600 mg
tablet, film coated		 Brand: Neurontin $14.11 per tablet
gabapentin 800 mg
tablet		 Generic $0.0860 per tablet
gabapentin 800 mg
tablet, coated		 Generic $0.0860 per tablet
gabapentin 800 mg
tablet, film coated		 Generic $0.0860 per tablet
gabapentin 800 mg
tablet, film coated		 Brand: Neurontin $16.88 per tablet
gabapentin 900 mg
tablet, film coated		 Brand: Gralise $15.28 per tablet

NADAC list of November 4, 2026; these prices took effect between December 17, 2025 and October 28, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA020235
NEURONTIN		 ViatrisDecember 30, 1993 37, latest April 25, 2025
2025: Labeling · 2024: Labeling · 2020: Labeling
NDA020882
NEURONTIN		 ViatrisOctober 9, 1998 26, latest April 25, 2025
2025: Labeling · 2024: Labeling · 2020: Labeling
NDA021129
NEURONTIN		 ViatrisMarch 2, 2000 28, latest April 25, 2025
2025: Labeling · 2024: Labeling · 2020: Labeling
NDA022544
GRALISE		 AlmaticaJanuary 28, 2011 20, latest April 25, 2025
2025: Labeling · 2023: Manufacturing (CMC) · 2021: Manufacturing (CMC)

Generic approvals (44)

Showing the 40 earliest of 44.

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. October 10, 2025 · Class II · Ongoing · D-0031-2026

    Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .

    Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 (Blister pack), NDC 55154-3363-0 (Outer Bag) — The Harvard Drug Group LLC

  2. October 10, 2025 · Class II · Ongoing · D-0030-2026

    Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .

    Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 — The Harvard Drug Group LLC

  3. June 19, 2025 · Class II · Ongoing · D-0508-2025

    Defective container; blister packaging inadequately sealed.

    Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-3363-0 — The Harvard Drug Group LLC

  4. June 19, 2025 · Class II · Ongoing · D-0507-2025

    Defective container; blister packaging inadequately sealed.

    Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, NDC 0904-6665-61 — The Harvard Drug Group LLC

  5. March 13, 2025 · Class II · Ongoing · D-0320-2025

    CGMP Deviations

    Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC — Glenmark Pharmaceuticals Inc., USA

  6. March 4, 2025 · Class III · Ongoing · D-0311-2025

    Cross Contamination

    Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-138-05; b) 1000-count bottles, NDC 62756-138-04, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured — SUN PHARMACEUTICAL INDUSTRIES INC

  7. March 4, 2025 · Class III · Ongoing · D-0312-2025

    Cross Contamination

    Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05; b) 1000-count bottles, NDC 62756-139-04; Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured — SUN PHARMACEUTICAL INDUSTRIES INC

  8. July 31, 2024 · Class II · Terminated · D-0634-2024

    Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets

    Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limited Hyderabad-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA NDC 70010-227-05 — Granules Pharmaceuticals Inc.

  9. April 24, 2023 · Class III · Terminated · D-0570-2023

    Product mixup: one foreign tablet found in product.

    Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. East Windsor, NJ 08520 Distributed by: Major Pharmaceuticals 1717 — The Harvard Drug Group

  10. February 17, 2023 · Class III · Terminated · D-0354-2023

    Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.

    Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured by ScieGen Pharmaceuticals Inc., Hauppauge, NY 11788, NDC: 50228-177-05. — Sciegen Pharmaceuticals Inc

  11. May 14, 2020 · Class III · Terminated · D-1272-2020

    Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.

    Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: Exelan Pharmaceuticals, Inc., Lawrenceville, GA 30046, Manufactured by: InvaGen Pharmaceuticals, Inc., Hauppauge, NY 11788, NDC 76282-405-05. — InvaGen Pharmaceuticals, Inc.

  12. March 18, 2020 · Class II · Terminated · D-1232-2020

    CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

    Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-198-99 — Aurobindo Pharma USA Inc.

  13. December 15, 2014 · Class II · Terminated · D-0337-2015

    Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.

    Gabapentin Capsules, USP, 300 mg, Rx Only, 100 capsules per bottle, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108, SIDCO Pharmaceutical Complex, Alathurt, Kanchipuram Dist-603 110, — Actavis Elizabeth LLC

  14. December 15, 2014 · Class II · Terminated · D-0338-2015

    Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.

    Gabapentin Capsules, USP, 100 mg, Rx Only, a) 100 capsules per bottle, NDC 45963-555-11, b) 500 Capsules per bottle, NDC 45963-555-50, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108 — Actavis Elizabeth LLC

  15. December 15, 2014 · Class II · Terminated · D-0336-2015

    Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.

    Gabapentin Capsules, USP, 400 mg, Rx Only, a) 100 capsules per bottle, NDC 14550-513-02, b) 500 Capsules per bottle, NDC 45963-557-50, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108 — Actavis Elizabeth LLC

  16. October 17, 2014 · Class II · Terminated · D-0330-2015

    Failed Tablet/Capsule Specifications: Complaints of empty capsules received.

    Gabapentin Capsules, USP 300 mg, 100-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141; Manufactured by: Aurobindo Pharma Limited, Unit-VII (SEZ), Mahaboob Nagar (Dt), AP-509302, INDIA, NDC 16 — Aurobindo Pharma USA Inc

  17. April 5, 2013 · Class III · Terminated · D-329-2013

    Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off - odor described as moldy, musty or fishy in nature.

    Glenmark Gabapentin Tablets, a) 600mg, 500- count bottle (NDC 68462-126-05), b) 800 mg, 500- count bottle (NDC 68462-127-05), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India, Manufactured — Glenmark Generics Inc., USA

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

RxCUI (RxNorm)105028, 105029, 105030, 261280, 261281, 283523, 310430, 310431, 310432, 310433 … (+10)
SPL set ID of the quoted label97935fd9-1d4a-43b6-a5d9-de994591187b
FDA labels (SPL)385
FDA applicationsNDA020235, NDA020882, NDA021129, NDA022544, 44 ANDA
Active ingredients (FDA)GABAPENTIN

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Neurontin, Viatris Specialty LLC, effective May 12, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

Report an error → · Information for medicine makers