Pramipexole Dihydrochloride
- Product NDC
- 16714-921
- 11-digit product format
- 167140921
- Labeler code
- 16714
- Product ID
- 16714-921_b5868063-c371-46c5-b47f-7d1b93f83a93
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pramipexole Dihydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- NorthStar RxLLC
- Application
- ANDA206156
- Marketing category
- ANDA
- Marketing start
- 2019-03-06
- Marketing end
- 0000-00-00
- Substance
- PRAMIPEXOLE DIHYDROCHLORIDE
- Active strength
- 4 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 | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 16714-921-01 | 16714092101 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-921-01) | 2019-03-06 | 0000-00-00 | No | No | Current |