Pramipexole Dihydrochloride
- Product NDC
- 68382-440
- 11-digit product format
- 683820440
- Labeler code
- 68382
- Product ID
- 68382-440_8906b45d-eaeb-4e7f-9aa2-dffa89109a8a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pramipexole Dihydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA078920
- Marketing category
- ANDA
- Marketing start
- 2022-11-23
- Marketing end
- 0000-00-00
- Substance
- PRAMIPEXOLE DIHYDROCHLORIDE
- Active strength
- 1 mg/1
- Pharmacologic classes
- Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68382-440-05 | 68382044005 | 500 TABLET in 1 BOTTLE (68382-440-05) | 500 tablet | 2022-11-23 | 0000-00-00 | No | No | Current |
| 68382-440-10 | 68382044010 | 1000 TABLET in 1 BOTTLE (68382-440-10) | 1000 tablet | 2022-11-23 | 0000-00-00 | No | No | Current |
| 68382-440-16 | 68382044016 | 90 TABLET in 1 BOTTLE (68382-440-16) | 90 tablet | 2022-11-23 | 0000-00-00 | No | No | Current |