Amitriptyline Hydrochloride
- Product NDC
- 0378-2625
- 11-digit product format
- 003782625
- Labeler code
- 0378
- Product ID
- 0378-2625_253441c9-4d92-42bb-964f-8b19d1dbacfb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amitriptyline hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA086009
- Marketing category
- ANDA
- Marketing start
- 1978-04-10
- Marketing end
- 0000-00-00
- Substance
- AMITRIPTYLINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Tricyclic Antidepressant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-2625-01 | 00378262501 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2625-01) | 1978-04-26 | 0000-00-00 | No | No | Current |
| 0378-2625-10 | 00378262510 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2625-10) | 1978-04-26 | 0000-00-00 | No | No | Current |