Quick answers
- What is Protriptyline hydrochloride used for?
- The FDA-approved label (Protriptyline Hydrochloride, Epic Pharma, LLC, July 25, 2023) says: “Protriptyline hydrochloride tablets are indicated for the treatment of symptoms of mental depression in patients who are under close medical supervision. Its activating properties make it particularly suitable for withdrawn and anergic patients.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Protriptyline hydrochloride have a boxed warning?
- Yes. The FDA label for Protriptyline 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 Protriptyline hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Protriptyline hydrochloride been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Protriptyline hydrochloride?
- 2 companies list prescription products of Protriptyline hydrochloride in the FDA NDC Directory, including Epic Pharma, LLC and Sigmapharm Laboratories, LLC.
What Protriptyline hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Protriptyline hydrochloride tablets are indicated for the treatment of symptoms of mental depression in patients who are under close medical supervision. Its activating properties make it particularly suitable for withdrawn and anergic patients.
— FDA label: Protriptyline Hydrochloride, Epic Pharma, LLC, effective July 25, 2023. Read the full label on DailyMed →
The FDA has 2 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 →
2 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 4 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 |
|---|---|---|
| protriptyline hydrochloride 10 mg tablet, film coated | Generic | $2.77 per tablet |
| protriptyline hydrochloride 5 mg tablet, film coated | Generic | $2.53 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.
- Epic Pharma, LLC2 products
- Sigmapharm Laboratories, LLC2 products
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (2)
- ANDA090462Sigmapharm Labs LLC · May 3, 2010
- ANDA202220Epic Pharma LLC · November 19, 2012
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 905168, 905172 |
|---|---|
| SPL set ID of the quoted label | c6c7c39e-e510-4f4a-bf7a-926f0e075d3a |
| FDA labels (SPL) | 2 |
| FDA applications | 2 ANDA |
| Active ingredients (FDA) | PROTRIPTYLINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Protriptyline Hydrochloride, Epic Pharma, LLC, effective July 25, 2023; 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 →