Amitriptyline Hydrochloride
- Product NDC
- 76420-694
- 11-digit product format
- 764200694
- Labeler code
- 76420
- Product ID
- 76420-694_12a7cd78-b13d-91e0-e063-6294a90a339b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA214548
- Marketing category
- ANDA
- Marketing start
- 2021-05-26
- Substance
- AMITRIPTYLINE HYDROCHLORIDE
- Active strength
- 25 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 |
|---|
| 76420-694-01 | 76420069401 | 100 TABLET, FILM COATED in 1 BOTTLE (76420-694-01) | 2024-03-02 | No | No | Historical |
| 76420-694-30 | 76420069430 | 30 TABLET, FILM COATED in 1 BOTTLE (76420-694-30) | 2024-03-02 | No | No | Historical |
| 76420-694-60 | 76420069460 | 60 TABLET, FILM COATED in 1 BOTTLE (76420-694-60) | 2024-03-02 | No | No | Historical |
| 76420-694-90 | 76420069490 | 90 TABLET, FILM COATED in 1 BOTTLE (76420-694-90) | 2024-03-02 | No | No | Historical |