Amitriptyline Hydrochloride
- Product NDC
- 68071-3913
- 11-digit product format
- 680713913
- Labeler code
- 68071
- Product ID
- 68071-3913_434543c0-554b-65ca-e063-6394a90a7bd5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA210086
- Marketing category
- ANDA
- Marketing start
- 2021-08-25
- Substance
- AMITRIPTYLINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Tricyclic Antidepressant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 26LUD4JO9K | AMITRIPTYLINE HYDROCHLORIDE | 549-18-8 | AMITRIPTYLINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3913-3 | 68071391303 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-3913-3) | 2025-11-10 | No | No | Historical |