Quick answers
- What is Amitriptyline hydrochloride used for?
- The FDA-approved label (Amitriptyline Hydrochloride, Remedyrepack Inc., September 9, 2026) says: “For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Amitriptyline hydrochloride have a boxed warning?
- Yes. The FDA label for Amitriptyline Hydrochloride has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Amitriptyline hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Amitriptyline hydrochloride been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started June 16, 2017 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Amitriptyline hydrochloride?
- 33 companies list prescription products of Amitriptyline hydrochloride in the FDA NDC Directory, including A-S Medication Solutions, Bryant Ranch Prepack and Remedyrepack Inc..
What Amitriptyline hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.
— FDA label: Amitriptyline Hydrochloride, Remedyrepack Inc., effective September 9, 2026. Read the full label on DailyMed →
The FDA has 119 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.
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 →
118 of 119 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet · Tablet, coated |
|---|---|
| Route | Oral |
| Prescription products | 211 in the FDA NDC Directory |
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 |
|---|---|---|
| amitriptyline hydrochloride 10 mg tablet | Generic | $0.0300 per tablet |
| amitriptyline hydrochloride 10 mg tablet, coated | Generic | $0.0300 per tablet |
| amitriptyline hydrochloride 10 mg tablet, film coated | Generic | $0.0300 per tablet |
| amitriptyline hydrochloride 100 mg tablet | Generic | $0.1437 per tablet |
| amitriptyline hydrochloride 100 mg tablet, coated | Generic | $0.1437 per tablet |
| amitriptyline hydrochloride 100 mg tablet, film coated | Generic | $0.1437 per tablet |
| amitriptyline hydrochloride 150 mg tablet | Generic | $0.2918 per tablet |
| amitriptyline hydrochloride 150 mg tablet, coated | Generic | $0.2918 per tablet |
| amitriptyline hydrochloride 150 mg tablet, film coated | Generic | $0.2918 per tablet |
| amitriptyline hydrochloride 25 mg tablet | Generic | $0.0517 per tablet |
| amitriptyline hydrochloride 25 mg tablet, coated | Generic | $0.0517 per tablet |
| amitriptyline hydrochloride 25 mg tablet, film coated | Generic | $0.0517 per tablet |
| amitriptyline hydrochloride 50 mg tablet | Generic | $0.1003 per tablet |
| amitriptyline hydrochloride 50 mg tablet, coated | Generic | $0.1003 per tablet |
| amitriptyline hydrochloride 50 mg tablet, film coated | Generic | $0.1003 per tablet |
| amitriptyline hydrochloride 75 mg tablet | Generic | $0.1262 per tablet |
| amitriptyline hydrochloride 75 mg tablet, coated | Generic | $0.1262 per tablet |
| amitriptyline hydrochloride 75 mg tablet, film coated | Generic | $0.1262 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.
- A-S Medication Solutions19 products
- Bryant Ranch Prepack18 products
- Remedyrepack Inc.11 products
- Preferred Pharmaceuticals Inc.9 products
- Northwind Health Company, LLC7 products
- Aphena Pharma Solutions - Tennessee, LLC7 products
- Direct_Rx7 products
- Sandoz Inc6 products
- AiPing Pharmaceutical, Inc.6 products
- Rising Pharma Holdings, Inc.6 products
- Sun Pharmaceutical Industries, Inc.6 products
- St. Mary's Medical Park Pharmacy6 products
- Coupler LLC6 products
- Zydus Pharmaceuticals USA Inc.6 products
- Advagen Pharma Ltd6 products
- Asclemed USA, Inc.6 products
- NorthStar Rx LLC6 products
- Unichem Pharmaceuticals (USA), Inc.6 products
- Golden State Medical Supply, Inc.6 products
- Zydus Lifesciences Limited6 products
- Centaur Pharmaceuticals Private Limited6 products
- Westminster Pharmaceuticals, LLC6 products
- Lifestar Pharma LLC6 products
- Proficient Rx LP5 products
- Aurobindo Pharma Limited5 products
- Advanced Rx of Tennessee, LLC5 products
- AvPAK5 products
- NuCare Pharmaceuticals, Inc.4 products
- PD-Rx Pharmaceuticals, Inc.3 products
- Advanced Rx Pharmacy of Tennessee, LLC3 products
- Accord Healthcare Inc.3 products
- Major Pharmaceuticals2 products
- American Health Packaging2 products
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (11)
- ANDA085968Sandoz · November 29, 1977
- ANDA086009Aurobindo Pharma USA · April 10, 1978
- ANDA089399Sun Pharm Inds Inc · July 14, 1987
- ANDA202446Accord Hlthcare · June 4, 2014
- ANDA210086Zydus Pharms · October 6, 2017
- ANDA212654Aiping Pharm Inc · April 7, 2020
- ANDA213999Mankind Pharma · February 19, 2021
- ANDA214548Unichem · May 19, 2021
- ANDA216243Breckenridge · June 6, 2022
- ANDA215376Rubicon Research · May 1, 2023
- ANDA217411Rising · May 19, 2023
Shortage status
The FDA drug shortage list does not show these products.
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.
-
June 16, 2017 · Class III · Terminated · D-0943-2017
Cross Contamination With Other Product: Imipramine
Amitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-count bottles (NDC 0781-1487-01) and b) 1000-count bottles ( NDC 0781-1487-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540 — Sandoz Incorporated
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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Amitriptyline Hydrochloride, Remedyrepack Inc., effective September 9, 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 →