Amitriptyline Hydrochloride
- Product NDC
- 71335-1254
- 11-digit product format
- 713351254
- Labeler code
- 71335
- Product ID
- 71335-1254_0f092467-7f36-1cb2-e063-6394a90a88a2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA089399
- Marketing category
- ANDA
- Marketing start
- 1987-07-14
- 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
Additional Listing Data
- Finished product
- Yes
- Brand name base
- Amitriptyline Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients
| Ingredient | Strength |
|---|
| AMITRIPTYLINE HYDROCHLORIDE | 25 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | 26LUD4JO9K |
| Rxcui | 856834 |
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 | Marketing end | Sample | Exclude flag | Status |
|---|
| 71335-1254-0 | 71335125400 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1254-0) | 2021-12-28 | 0000-00-00 | No | No | Current |
| 71335-1254-1 | 71335125401 | 20 TABLET, FILM COATED in 1 BOTTLE (71335-1254-1) | 2021-12-28 | 0000-00-00 | No | No | Current |
| 71335-1254-2 | 71335125402 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1254-2) | 2019-07-19 | 0000-00-00 | No | No | Current |
| 71335-1254-3 | 71335125403 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1254-3) | 2021-12-28 | 0000-00-00 | No | No | Current |
| 71335-1254-4 | 71335125404 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1254-4) | 2019-07-24 | 0000-00-00 | No | No | Current |
| 71335-1254-5 | 71335125405 | 50 TABLET, FILM COATED in 1 BOTTLE (71335-1254-5) | 2021-12-28 | 0000-00-00 | No | No | Current |
| 71335-1254-6 | 71335125406 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1254-6) | 2019-06-27 | 0000-00-00 | No | No | Current |
| 71335-1254-7 | 71335125407 | 45 TABLET, FILM COATED in 1 BOTTLE (71335-1254-7) | 2021-12-28 | 0000-00-00 | No | No | Current |
| 71335-1254-8 | 71335125408 | 28 TABLET, FILM COATED in 1 BOTTLE (71335-1254-8) | 2021-12-28 | 0000-00-00 | No | No | Current |
| 71335-1254-9 | 71335125409 | 56 TABLET, FILM COATED in 1 BOTTLE (71335-1254-9) | 2021-12-28 | 0000-00-00 | No | No | Current |