Quick answers
- What is Carbamazepine used for?
- The FDA-approved label (Tegretol, Novartis Pharmaceuticals Corporation, August 20, 2026) says: “Epilepsy Tegretol is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of Tegretol as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Carbamazepine have a boxed warning?
- Yes. The FDA label for Tegretol has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Carbamazepine?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated December 19, 2025). Ask your pharmacist about alternatives.
- Has Carbamazepine been recalled?
- FDA enforcement reports list 7 recalls of products of this medicine; the newest started August 7, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Carbamazepine?
- 45 companies list prescription products of Carbamazepine in the FDA NDC Directory, including Bryant Ranch Prepack, Remedyrepack Inc. and Sun Pharmaceutical Industries, Inc..
What Carbamazepine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Epilepsy Tegretol is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of Tegretol as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types. …
— FDA label: Tegretol, Novartis Pharmaceuticals Corporation, effective August 20, 2026. Read the full label on DailyMed →
The FDA has 64 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.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
64 of 64 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, extended release · Tablet · Capsule, extended release · Tablet, chewable · Suspension · Tablet, film coated, extended release |
|---|---|
| Route | Oral |
| Prescription products | 157 in the FDA NDC Directory |
| Brand names | Tegretol XR, Equetro, Carbatrol, Tegretol, Carbamazepin |
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.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| carbamazepine 100 mg capsule, extended release | Generic | $1.09 per capsule |
| carbamazepine 100 mg capsule, extended release | Brand: Carbatrol | $1.70 per capsule |
| carbamazepine 100 mg capsule, extended release | Brand: Equetro | $3.64 per capsule |
| carbamazepine 100 mg tablet, chewable | Generic | $0.2273 per tablet |
| carbamazepine 100 mg tablet, extended release | Generic | $0.1995 per tablet |
| carbamazepine 100 mg tablet, extended release | Brand: Tegretol XR | $1.63 per tablet |
| carbamazepine 100 mg tablet, film coated, extended release | Generic | $0.1995 per tablet |
| carbamazepine 100 mg/5 mL suspension | Generic | $0.0886 per mL |
| carbamazepine 100 mg/5 mL suspension | Brand: Tegretol | $0.4365 per mL |
| carbamazepine 200 mg capsule, extended release | Generic | $1.03 per capsule |
| carbamazepine 200 mg capsule, extended release | Brand: Carbatrol | $1.69 per capsule |
| carbamazepine 200 mg capsule, extended release | Brand: Equetro | $4.17 per capsule |
| carbamazepine 200 mg tablet | Generic | $0.1193 per tablet |
| carbamazepine 200 mg tablet | Brand: Tegretol | $3.04 per tablet |
| carbamazepine 200 mg tablet, chewable | Generic | $1.19 per tablet |
| carbamazepine 200 mg tablet, extended release | Generic | $0.3794 per tablet |
| carbamazepine 200 mg tablet, extended release | Brand: Tegretol XR | $3.24 per tablet |
| carbamazepine 200 mg tablet, film coated, extended release | Generic | $0.3794 per tablet |
| carbamazepine 300 mg capsule, extended release | Generic | $1.13 per capsule |
| carbamazepine 300 mg capsule, extended release | Brand: Carbatrol | $1.70 per capsule |
| carbamazepine 300 mg capsule, extended release | Brand: Equetro | $4.70 per capsule |
| carbamazepine 400 mg tablet, extended release | Generic | $0.7083 per tablet |
| carbamazepine 400 mg tablet, extended release | Brand: Tegretol XR | $6.49 per tablet |
| carbamazepine 400 mg tablet, film coated, extended release | Generic | $0.7083 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 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.
- Bryant Ranch Prepack14 products
- Remedyrepack Inc.11 products
- Sun Pharmaceutical Industries, Inc.7 products
- Coupler LLC6 products
- Golden State Medical Supply, Inc.6 products
- NorthStar Rx LLC5 products
- Novartis Pharmaceuticals Corporation5 products
- American Health Packaging5 products
- Chartwell RX, LLC5 products
- Torrent Pharmaceuticals Limited5 products
- Umedica Laboratories USA Inc.5 products
- Alembic Pharmaceuticals Inc.4 products
- Alembic Pharmaceuticals Limited4 products
- ANI Pharmaceuticals, Inc.4 products
- Apotex Corp.4 products
- AvPAK4 products
- Validus Pharmaceuticals LLC3 products
- Jubilant Cadista Pharmaceuticals Inc.3 products
- Upsher-Smith Laboratories, LLC3 products
- Bostal LLC3 products
- Ascend Laboratories, LLC3 products
- Zydus Lifesciences Limited3 products
- Rising Pharma Holdings, Inc.3 products
- Ajanta Pharma USA Inc.3 products
- Zydus Pharmaceuticals USA Inc.3 products
- Major Pharmaceuticals3 products
- Epic Pharma, LLC3 products
- Takeda Pharmaceuticals America, Inc.3 products
- Ingenus Pharmaceuticals, LLC3 products
- Preferred Pharmaceuticals Inc.2 products
- Oryza Pharmaceuticals Inc.2 products
- Nivagen Pharmaceuticals, Inc.2 products
- Chartwell Governmental & Specialty RX, LLC.2 products
- Aphena Pharma Solutions - Tennessee, LLC2 products
- Precision Dose, Inc.2 products
- A-S Medication Solutions2 products
- NCS HealthCare of KY, LLC dba Vangard Labs2 products
- Unichem Pharmaceuticals (USA), Inc.1 product
- Direct_Rx1 product
- Cardinal Health 107, LLC1 product
- Atlantic Biologicals Corps1 product
- PD-Rx Pharmaceuticals, Inc.1 product
- Proficient Rx LP1 product
- NuCare Pharmaceuticals, Inc.1 product
- Bionpharma Inc.1 product
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.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA016608 TEGRETOL | Novartis | March 11, 1968 | 86, latest July 15, 2026 2026: Labeling · 2025: Labeling · 2023: Labeling |
| NDA018927 TEGRETOL | Novartis | December 18, 1987 | 44, latest July 15, 2026 2026: Labeling · 2025: Labeling · 2023: Labeling |
| NDA020234 TEGRETOL-XR | Novartis | March 25, 1996 | 38, latest July 15, 2026 2026: Labeling · 2025: Labeling · 2023: Labeling |
| NDA020712 CARBATROL | Takeda Pharms USA | September 30, 1997 | 26, latest April 11, 2023 2023: Labeling · 2021: Labeling · 2018: Labeling |
| NDA021710 EQUETRO | Validus Pharms | December 10, 2004 | 9, latest October 14, 2022 2022: Labeling · 2016: Efficacy · 2016: Efficacy |
Generic approvals (28)
- ANDA070541Teva · September 17, 1986
- ANDA074649Taro · October 3, 1996
- ANDA075687Taro Pharm Inds · October 24, 2000
- ANDA075712Torrent Pharms · July 5, 2001
- ANDA075948Apotex · February 27, 2002
- ANDA075714Chartwell Rx · June 5, 2002
- ANDA076729Taro · September 20, 2004
- ANDA077272Torrent Pharms · December 7, 2005
- ANDA078115Taro · March 31, 2009
- ANDA076697Ani Pharms · May 20, 2011
- ANDA078986Apotex Inc · November 25, 2011
- ANDA205571Zydus Pharms · February 7, 2019
- ANDA207798Umedica · April 15, 2020
- ANDA211623Unique Pharm · April 24, 2020
- ANDA213311Cspc Ouyi · April 13, 2021
- ANDA212948Anbison Lab · September 30, 2021
- ANDA215591Zhejiang Jiuzhou · March 31, 2022
- ANDA216594Umedica · August 18, 2022
- ANDA213284Unichem · August 22, 2022
- ANDA214277Novitium Pharma · October 6, 2022
- ANDA216404Ingenus Pharms LLC · December 2, 2022
- ANDA216235Sciecure Pharma Inc · March 2, 2023
- ANDA216193Ajanta Pharma Ltd · March 24, 2023
- ANDA218221Bionpharma · February 16, 2024
- ANDA212524Torrent · January 13, 2025
- ANDA217277Alkem Labs Ltd · January 14, 2025
- ANDA216623Alembic · April 16, 2025
- ANDA219939Alembic · July 25, 2025
Shortage status
To be discontinued · updated December 19, 2025 · first posted December 19, 2025
| Product | Carbatrol, Capsule, Extended Release, 300 mg (NDC 54092-173-12) |
|---|---|
| Company | Takeda Pharmaceuticals USA Inc. |
Ask your pharmacist whether your product is affected and what the options are.
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.
-
August 7, 2026 · Class II · Ongoing · D-0771-2026
CGMP deviations: tablets with black specks.
Carbamazepine Tablets, USP, 200mg, packaged in a)1000-count bottles (NDC 51407-215-10), b) 100-count bottles (NDC 51407-215-01), Rx Only, Manufactured by: Taro Pharmaceutical Industries Ltd., Marketed by: GSMS, Incorpora — Golden State Medical Supply Inc.
-
August 3, 2026 · Class II · Ongoing · D-0770-2026
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC 51 — SUN PHARMACEUTICAL INDUSTRIES INC
-
September 15, 2025 · Class II · Ongoing · D-0675-2025
Failed Dissolution Specifications.
Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Health Packaging, Columbus, OH 43217. Carton NDC 60687-594-21; (Individual Dose NDC: 60687-594-11) — Amerisource Health Services LLC
-
December 2, 2021 · Class II · Terminated · D-0365-2022
Failed Dissolution Specifications
Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufactured by: Torrent Pharmaceuticals Ltd. Bharuch-392130, India Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. — Torrent Pharma Inc.
-
August 6, 2021 · Class II · Terminated · D-0807-2021
Failed Dissolution Specifications
Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd., Bharuch-392130, India; Manufactured for: Torrent Pharma, Inc., Basking Ridge, NJ 07920; Distr — The Harvard Drug Group
-
May 11, 2020 · Class II · Terminated · D-1317-2020
Failed Dissolution Specifications
Carbamazepine Tablets, USP 200 mg, packaged in a 500-count bottle, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd, Bharuch 392130, India; Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920, NDC 13668-2 — Torrent Pharma Inc.
-
October 21, 2014 · Class III · Terminated · D-0049-2015
Marketed without an Approved NDA/ANDA: One lot was on hold-pending release status when it was erroneously made available for sale in the inventory control system. An alternate manufacturing site for the Carbamazepine API final intermediate was pending approval.
Carbamazepine Tablets USP, 200 mg, 1000 Tablets per Bottle, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 26110 Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC — Taro Pharmaceuticals U.S.A., Inc.
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) | 199378, 200131, 200133, 308971, 308972, 308973, 308976, 308977, 308979, 313931 … (+10) |
|---|---|
| SPL set ID of the quoted label | 8d409411-aa9f-4f3a-a52c-fbcb0c3ec053 |
| FDA labels (SPL) | 64 |
| FDA applications | NDA016608, NDA018927, NDA020234, NDA020712, NDA021710, 28 ANDA |
| Active ingredients (FDA) | CARBAMAZEPINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Tegretol, Novartis Pharmaceuticals Corporation, effective August 20, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- 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 →