Pramipexole Dihydrochloride
- Product NDC
- 65862-604
- 11-digit product format
- 658620604
- Labeler code
- 65862
- Product ID
- 65862-604_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
- .125 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
openFDA Listing Details
- Product ID
- 65862-604_1e01cf5f-29b7-40ce-8c46-40f8dc65ce3e
- SPL ID
- 1e01cf5f-29b7-40ce-8c46-40f8dc65ce3e
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Pramipexole Dihydrochloride
- Generic name
- Pramipexole Dihydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Marketing start
- 2012-10-26
- Marketing category
- ANDA
- Application number
- ANDA202633
- Pharmacologic classes
- Dopamine Agonists [MoA]; Nonergot Dopamine Agonist [EPC]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| PRAMIPEXOLE DIHYDROCHLORIDE | .125 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 3D867NP06J |
| Rxcui | 858625, 859033, 859040, 859044, 859048, 859052 |
| Spl Set Id | 3f90971a-e005-4dd3-bb93-b09125ada3c8 |
| Manufacturer Name | Aurobindo Pharma Limited |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 65862-604-78 | 10 BLISTER PACK in 1 CARTON (65862-604-78) / 10 TABLET in 1 BLISTER PACK (65862-604-10) | 2012-10-26 | No |
| 65862-604-81 | 8000 TABLET in 1 BAG (65862-604-81) | 26-OCT-12 | |
| 65862-604-90 | 90 TABLET in 1 BOTTLE (65862-604-90) | 2012-10-26 | No |
| 65862-604-99 | 1000 TABLET in 1 BOTTLE (65862-604-99) | 2012-10-26 | No |
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 |
|---|
| 65862-604-78 | 65862060478 | 10 BLISTER PACK in 1 CARTON (65862-604-78) / 10 TABLET in 1 BLISTER PACK (65862-604-10) | 10 blister pack | 2012-10-26 | No | No | Historical |
| 65862-604-90 | 65862060490 | 90 TABLET in 1 BOTTLE (65862-604-90) | 90 tablet | 2012-10-26 | No | No | Historical |
| 65862-604-99 | 65862060499 | 1000 TABLET in 1 BOTTLE (65862-604-99) | 1000 tablet | 2012-10-26 | No | No | Historical |