AMITRIPTYLINE HYDROCHLORIDE
- Product NDC
- 43063-863
- 11-digit product format
- 430630863
- Labeler code
- 43063
- Product ID
- 43063-863_e6d88144-240d-220d-e053-2995a90ac043
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMITRIPTYLINE HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA202446
- Marketing category
- ANDA
- Marketing start
- 2014-12-05
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-863 | AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 32 | Legacy NDC | 20250429_964fd565-25db-472a-bbf6-abdc81f1ef0b.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43063-863-28 | 43063086328 | 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-863-28) | 2019-09-24 | 0000-00-00 | No | No | Current |
| 43063-863-30 | 43063086330 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-863-30) | 2018-06-21 | 0000-00-00 | No | No | Current |