Pramipexole Dihydrochloride
- Product NDC
- 65862-608
- 11-digit product format
- 658620608
- Labeler code
- 65862
- Product ID
- 65862-608_1e01cf5f-29b7-40ce-8c46-40f8dc65ce3e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pramipexole Dihydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA202633
- Marketing category
- ANDA
- Marketing start
- 2012-10-26
- Substance
- PRAMIPEXOLE DIHYDROCHLORIDE
- Active strength
- 1 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 |
|---|
| 65862-608-78 | 65862060878 | 10 BLISTER PACK in 1 CARTON (65862-608-78) / 10 TABLET in 1 BLISTER PACK (65862-608-10) | 10 blister pack | 2012-10-26 | No | No | Historical |
| 65862-608-90 | 65862060890 | 90 TABLET in 1 BOTTLE (65862-608-90) | 90 tablet | 2012-10-26 | No | No | Historical |
| 65862-608-99 | 65862060899 | 1000 TABLET in 1 BOTTLE (65862-608-99) | 1000 tablet | 2012-10-26 | No | No | Historical |