Pramipexole Dihydrochloride
- Product NDC
- 46708-577
- 11-digit product format
- 467080577
- Labeler code
- 46708
- Product ID
- 46708-577_c9aa6022-4a1b-4fd5-a7ba-04158d9b5a05
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pramipexole Dihydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA204518
- Marketing category
- ANDA
- Marketing start
- 2019-01-03
- Substance
- PRAMIPEXOLE DIHYDROCHLORIDE
- Active strength
- 2.25 mg/1
- Pharmacologic classes
- Dopamine Agonists [MoA], Nonergot Dopamine Agonist [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 |
|---|
| 3D867NP06J | PRAMIPEXOLE DIHYDROCHLORIDE | 191217-81-9 | PRAMIPEXOLE DIHYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 46708-577-30 | 46708057730 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-577-30) | 2019-01-03 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Pramipexole Dihydrochloride | Alembic Pharmaceuticals Limited | 2023-01-27 | Human Prescription Drug Label | 2 |