Active ingredient
Nortriptyline
85 finished FDA listings contain Nortriptyline as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- NORTRIPTYLINE HYDROCHLORIDE
- Dosage forms
- Capsule, Solution
- Routes
- Oral
- Manufacturers / labelers
- 28
- Strengths listed
- 10 mg/1 · 10 mg/5ml · 25 mg/1 · 50 mg/1 · 75 mg/1
- Brand names in FDA listings
- Pamelor
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 7531
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 018013 | SPECGX LLC | 1977-08-01 | 4 |
| ANDA 073556 | DR REDDYS LABS SA | 1992-03-30 | 34 |
| ANDA 074132 | TEVA | 1995-03-27 | 21 |
| ANDA 075520 | TARO | 2000-05-08 | 16 |
| ANDA 075606 | PHARM ASSOC | 2000-08-23 | 1 |
| ANDA 213441 | ZYDUS LIFESCIENCES | 2021-02-24 | 8 |
| ANDA 217731 | RUBICON RESEARCH | 2023-08-15 | 1 |
Official labeling on DailyMed
- NORTRIPTYLINE HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.] · version 3 · 2026-09-07
- NORTRIPTYLINE HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.] · version 4 · 2026-08-31
- NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK] · version 17 · 2026-08-20
- NORTRIPTYLINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.] · version 3 · 2026-08-06
- NORTRIPTYLINE HYDROCHLORIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 11 · 2026-07-16
- NORTRIPTYLINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP] · version 1 · 2026-07-15
- NORTRIPTYLINE HYDROCHLORIDE CAPSULE [ST. MARY'S MEDICAL PARK PHARMACY] · version 3 · 2026-07-06
- NORTRIPTYLINE HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.] · version 3 · 2026-06-15
- NORTRIPTYLINE HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.] · version 5 · 2026-06-11
- NORTRIPTYLINE HCL CAPSULE [DIRECT_RX] · version 3 · 2026-06-08
- NORTRIPTYLINE HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.] · version 3 · 2026-06-03
- NORTRIPTYLINE HYDROCHLORIDE CAPSULE [ST. MARY'S MEDICAL PARK PHARMACY] · version 4 · 2026-05-21
Showing the 12 most recent of 56 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.