Pramipexole Dihydrochloride
- Product NDC
- 50090-5036
- 11-digit product format
- 500905036
- Labeler code
- 50090
- Product ID
- 50090-5036_32458c95-4cff-4b30-bc62-0f0b2203a584
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pramipexole Dihydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA202633
- Marketing category
- ANDA
- Marketing start
- 2012-10-26
- Substance
- PRAMIPEXOLE DIHYDROCHLORIDE
- Active strength
- 1.5 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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-5036-0 | 50090503600 | 90 TABLET in 1 BOTTLE (50090-5036-0) | 90 tablet | 2020-05-06 | No | No | Historical |