Amitriptyline Hydrochloride
- Product NDC
- 82804-048
- 11-digit product format
- 828040048
- Labeler code
- 82804
- Product ID
- 82804-048_6dc9d113-1156-43ec-a7eb-253c2ff6bcfa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amitriptyline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA214548
- Marketing category
- ANDA
- Marketing start
- 2021-05-26
- Substance
- AMITRIPTYLINE HYDROCHLORIDE
- Active strength
- 75 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 |
|---|
| 82804-048-30 | 82804004830 | 30 TABLET, FILM COATED in 1 BOTTLE (82804-048-30) | 2023-12-21 | No | No | Historical |
| 82804-048-60 | 82804004860 | 60 TABLET, FILM COATED in 1 BOTTLE (82804-048-60) | 2023-12-21 | No | No | Historical |
| 82804-048-90 | 82804004890 | 90 TABLET, FILM COATED in 1 BOTTLE (82804-048-90) | 2023-12-21 | No | No | Historical |