Amitriptyline Hydrochloride
- Product NDC
- 70518-4469
- 11-digit product format
- 705184469
- Labeler code
- 70518
- Product ID
- 70518-4469_44e417ef-3166-675d-e063-6394a90a7615
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA212654
- Marketing category
- ANDA
- Marketing start
- 2025-09-08
- Substance
- AMITRIPTYLINE HYDROCHLORIDE
- Active strength
- 50 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 |
|---|
| 70518-4469-0 | 70518446900 | 90 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-4469-0) | 2025-09-08 | No | No | Historical |
| 70518-4469-1 | 70518446901 | 30 TABLET, COATED in 1 BLISTER PACK (70518-4469-1) | 2025-09-08 | No | No | Historical |
| 70518-4469-2 | 70518446902 | 30 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-4469-2) | 2025-11-30 | No | No | Historical |