Quick answers
- What is Imipramine used for?
- The FDA-approved label (Imipramine Pamoate, Remedyrepack Inc., August 20, 2026) says: “For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. One to three weeks of treatment may be needed before optimal therapeutic effects are evident.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Imipramine have a boxed warning?
- Yes. The FDA label for Imipramine Pamoate has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Imipramine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Imipramine been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started October 8, 2021 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Imipramine?
- 14 companies list prescription products of Imipramine in the FDA NDC Directory, including Lupin Pharmaceuticals, Inc., PD-Rx Pharmaceuticals, Inc. and Proficient Rx LP.
What Imipramine 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 other depressive states. One to three weeks of treatment may be needed before optimal therapeutic effects are evident.
— FDA label: Imipramine Pamoate, Remedyrepack Inc., effective August 20, 2026. Read the full label on DailyMed →
The FDA has 19 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 →
19 of 19 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet · Capsule |
|---|---|
| Route | Oral |
| Prescription products | 40 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 |
|---|---|---|
| imipramine hydrochloride 10 mg tablet | Generic | $0.0788 per tablet |
| imipramine hydrochloride 10 mg tablet, film coated | Generic | $0.0788 per tablet |
| imipramine hydrochloride 25 mg tablet | Generic | $0.0870 per tablet |
| imipramine hydrochloride 25 mg tablet, film coated | Generic | $0.0870 per tablet |
| imipramine hydrochloride 50 mg tablet | Generic | $0.1528 per tablet |
| imipramine hydrochloride 50 mg tablet, film coated | Generic | $0.1528 per tablet |
| imipramine pamoate 100 mg capsule | Generic | $3.75 per capsule |
| imipramine pamoate 150 mg capsule | Generic | $2.88 per capsule |
| imipramine pamoate 75 mg capsule | Generic | $3.32 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.
- Lupin Pharmaceuticals, Inc.7 products
- PD-Rx Pharmaceuticals, Inc.5 products
- Proficient Rx LP4 products
- Hikma Pharmaceuticals USA Inc.4 products
- Strides Pharma Science Limited3 products
- Leading Pharma, LLC3 products
- Remedyrepack Inc.3 products
- Oxford Pharmaceuticals, LLC3 products
- Advanced Rx Pharmacy of Tennessee, LLC2 products
- Bryant Ranch Prepack2 products
- Key Therapeutics1 product
- Coupler LLC1 product
- A-S Medication Solutions1 product
- NuCare Pharmaceuticals, Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (10)
- ANDA088262Strides Pharma Intl · October 21, 1983
- ANDA088276Strides Pharma Intl · October 21, 1983
- ANDA088292Strides Pharma Intl · October 21, 1983
- ANDA040751Oxford Pharms · February 28, 2008
- ANDA090441Chartwell · March 11, 2010
- ANDA090444Lupin Ltd · April 16, 2010
- ANDA091099Hikma · April 16, 2010
- ANDA040903Leading · October 24, 2012
- ANDA090442—
- ANDA090443—
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 8, 2021 · Class II · Terminated · D-0027-2022
Out of specification result observed in a dissolution test at the 9-month long term stability time point.
Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 UNited States. Manufactured by: Lupin Limited, Pithampur, (M.P.) 454 775 India NDC# 681 — Lupin 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) — Imipramine Pamoate, Remedyrepack Inc., 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 →