Quick answers
- What is Desipramine hydrochloride used for?
- The FDA-approved label (Norpramin, Validus Pharmaceuticals LLC, July 3, 2025) says: “NORPRAMIN is indicated for the treatment of depression.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Desipramine hydrochloride have a boxed warning?
- Yes. The FDA label for Norpramin has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Desipramine hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Desipramine hydrochloride been recalled?
- FDA enforcement reports list 6 recalls of products of this medicine; the newest started October 6, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Desipramine hydrochloride?
- 10 companies list prescription products of Desipramine hydrochloride in the FDA NDC Directory, including Validus Pharmaceuticals LLC, Ingenus Pharmaceuticals, LLC and Alembic Pharmaceuticals Inc..
What Desipramine hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
NORPRAMIN is indicated for the treatment of depression.
— FDA label: Norpramin, Validus Pharmaceuticals LLC, effective July 3, 2025. Read the full label on DailyMed →
The FDA has 9 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 →
8 of 9 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet · Tablet, sugar coated |
|---|---|
| Route | Oral |
| Prescription products | 45 in the FDA NDC Directory |
| Brand names | Norpramin |
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 |
|---|---|---|
| desipramine hydrochloride 10 mg tablet | Generic | $0.1063 per tablet |
| desipramine hydrochloride 10 mg tablet, film coated | Generic | $0.1063 per tablet |
| desipramine hydrochloride 100 mg tablet | Generic | $0.4492 per tablet |
| desipramine hydrochloride 100 mg tablet, film coated | Generic | $0.4492 per tablet |
| desipramine hydrochloride 150 mg tablet | Generic | $0.8317 per tablet |
| desipramine hydrochloride 150 mg tablet, film coated | Generic | $0.8317 per tablet |
| desipramine hydrochloride 25 mg tablet | Generic | $0.1242 per tablet |
| desipramine hydrochloride 25 mg tablet, film coated | Generic | $0.1242 per tablet |
| desipramine hydrochloride 50 mg tablet | Generic | $0.2268 per tablet |
| desipramine hydrochloride 50 mg tablet, film coated | Generic | $0.2268 per tablet |
| desipramine hydrochloride 75 mg tablet | Generic | $0.2799 per tablet |
| desipramine hydrochloride 75 mg tablet, film coated | Generic | $0.2799 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.
- Validus Pharmaceuticals LLC6 products
- Ingenus Pharmaceuticals, LLC6 products
- Alembic Pharmaceuticals Inc.6 products
- Amneal Pharmaceuticals LLC6 products
- Chartwell RX, LLC6 products
- Actavis Pharma, Inc.6 products
- Alembic Pharmaceuticals Limited6 products
- Remedyrepack Inc.1 product
- Direct_Rx1 product
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals 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 |
|---|---|---|---|
| NDA014399 NORPRAMIN | Validus Pharms | November 20, 1964 | 45, latest June 24, 2025 2025: Labeling · 2018: Labeling · 2014: Manufacturing (CMC) |
Generic approvals (9)
- ANDA071588Actavis Totowa · June 5, 1987
- ANDA071601Actavis Totowa · June 5, 1987
- ANDA071602Actavis Totowa · October 5, 1987
- ANDA071766Actavis Totowa · October 5, 1987
- ANDA074430Actavis Totowa · February 9, 1996
- ANDA208105Amneal Pharms Co · March 17, 2016
- ANDA207433Heritage · May 5, 2016
- ANDA204963Ingenus Pharms LLC · December 26, 2017
- ANDA209785Alembic · July 7, 2021
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.
-
October 6, 2025 · Class II · Ongoing · D-0109-2026
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Desipramine Hydrochloride Tablets, USP, 50 mg, 100 count bottle (NDC 23155-580-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816. — Heritage Pharmaceuticals Inc
-
October 6, 2025 · Class II · Ongoing · D-0110-2026
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-581-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816. — Heritage Pharmaceuticals Inc
-
October 6, 2025 · Class II · Ongoing · D-0108-2026
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Desipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle (NDC 23155-579-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816. — Heritage Pharmaceuticals Inc
-
October 6, 2025 · Class II · Ongoing · D-0111-2026
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Desipramine Hydrochloride Tablets, USP, 100 mg, 100 count bottle (NDC 23155-582-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816. — Heritage Pharmaceuticals Inc
-
October 6, 2025 · Class II · Ongoing · D-0112-2026
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-583-25), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816. — Heritage Pharmaceuticals Inc
-
October 6, 2025 · Class II · Ongoing · D-0107-2026
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Desipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-578-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816. — Heritage Pharmaceuticals 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) — Norpramin, Validus Pharmaceuticals LLC, effective July 3, 2025; 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 →