Amitriptyline Hydrochloride
- Product NDC
- 80425-0287
- 11-digit product format
- 804250287
- Labeler code
- 80425
- Product ID
- 80425-0287_2a9b9724-0257-e829-e063-6394a90a1c07
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA214548
- Marketing category
- ANDA
- Marketing start
- 2023-03-22
- 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0287-1 | 80425028701 | 30 TABLET, FILM COATED in 1 BOTTLE (80425-0287-1) | 2023-03-22 | No | No | Historical |
| 80425-0287-2 | 80425028702 | 60 TABLET, FILM COATED in 1 BOTTLE (80425-0287-2) | 2023-03-22 | No | No | Historical |
| 80425-0287-3 | 80425028703 | 90 TABLET, FILM COATED in 1 BOTTLE (80425-0287-3) | 2023-03-22 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Amitriptyline HCL Tablets | Advanced Rx Pharmacy of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL | 3 |