Quick answers
- What is Nortriptyline hydrochloride used for?
- The FDA-approved label (Pamelor, SpecGx LLC, December 4, 2024) says: “Pamelor™ (nortriptyline HCl) is indicated for the relief of symptoms of depression. Endogenous depressions are 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 Nortriptyline hydrochloride have a boxed warning?
- Yes. The FDA label for Pamelor has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Nortriptyline hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Nortriptyline hydrochloride been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started January 8, 2021 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Nortriptyline hydrochloride?
- 25 companies list prescription products of Nortriptyline hydrochloride in the FDA NDC Directory, including Bryant Ranch Prepack, Proficient Rx LP and Remedyrepack Inc..
What Nortriptyline hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Pamelor™ (nortriptyline HCl) is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.
— FDA label: Pamelor, SpecGx LLC, effective December 4, 2024. Read the full label on DailyMed →
The FDA has 55 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 →
55 of 55 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule · Solution |
|---|---|
| Route | Oral |
| Prescription products | 85 in the FDA NDC Directory |
| Brand names | Pamelor |
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 |
|---|---|---|
| nortriptyline hydrochloride 10 mg capsule | Generic | $0.1005 per capsule |
| nortriptyline hydrochloride 10 mg/5 mL solution | Generic | $0.2564 per mL |
| nortriptyline hydrochloride 25 mg capsule | Generic | $0.1452 per capsule |
| nortriptyline hydrochloride 50 mg capsule | Generic | $0.2009 per capsule |
| nortriptyline hydrochloride 75 mg capsule | Generic | $0.2661 per capsule |
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 Prepack11 products
- Proficient Rx LP9 products
- Remedyrepack Inc.6 products
- Direct_Rx6 products
- SpecGx LLC4 products
- Asclemed USA, Inc.4 products
- Teva Pharmaceuticals USA, Inc.4 products
- Zydus Pharmaceuticals USA Inc.4 products
- Dr. Reddy's Laboratories Inc.4 products
- Sun Pharmaceutical Industries, Inc.4 products
- Zydus Lifesciences Limited4 products
- Coupler LLC4 products
- A-S Medication Solutions4 products
- St. Mary's Medical Park Pharmacy2 products
- American Health Packaging2 products
- Preferred Pharmaceuticals Inc.2 products
- PD-Rx Pharmaceuticals, Inc.2 products
- Northwind Health Company, LLC2 products
- Mayne Pharma Inc.1 product
- Aphena Pharma Solutions - Tennessee, LLC1 product
- Advanced Rx Pharmacy of Tennessee, LLC1 product
- Advanced Rx of Tennessee, LLC1 product
- PAI Holdings, LLC dba PAI Pharma1 product
- NuCare Pharmaceuticals, Inc.1 product
- Advagen Pharma Ltd1 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 |
|---|---|---|---|
| NDA018013 PAMELOR | Specgx LLC | August 1, 1977 | 47, latest April 9, 2019 2019: Labeling · 2014: Labeling · 2014: Labeling |
Generic approvals (6)
- ANDA073556DR Reddys Labs SA · March 30, 1992
- ANDA074132Teva · March 27, 1995
- ANDA075520Taro · May 8, 2000
- ANDA075606Pharm Assoc · August 23, 2000
- ANDA213441Zydus Lifesciences · February 24, 2021
- ANDA217731Rubicon Research · August 15, 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.
-
January 8, 2021 · Class II · Terminated · D-0246-2021
CGMP deviations.
Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532 NDC 51672-4001-1 — 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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Pamelor, SpecGx LLC, effective December 4, 2024; 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 →