Amitriptyline Hydrochloride
- Product NDC
- 68788-4052
- 11-digit product format
- 687884052
- Labeler code
- 68788
- Product ID
- 68788-4052_15c2afe3-3309-4abc-87d1-f3eab8d89b20
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA217411
- Marketing category
- ANDA
- Marketing start
- 2025-11-17
- Substance
- AMITRIPTYLINE HYDROCHLORIDE
- Active strength
- 100 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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-4052-3 | 68788405203 | 30 TABLET in 1 BOTTLE (68788-4052-3) | 30 tablet | 2025-11-17 | No | No | Historical |
| 68788-4052-6 | 68788405206 | 60 TABLET in 1 BOTTLE (68788-4052-6) | 60 tablet | 2025-11-17 | No | No | Historical |
| 68788-4052-8 | 68788405208 | 28 TABLET in 1 BOTTLE (68788-4052-8) | 28 tablet | 2025-11-17 | No | No | Historical |
| 68788-4052-9 | 68788405209 | 90 TABLET in 1 BOTTLE (68788-4052-9) | 90 tablet | 2025-11-17 | No | No | Historical |