Pramipexole Dihydrochloride
- Product NDC
- 50090-7816
- 11-digit product format
- 500907816
- Labeler code
- 50090
- Product ID
- 50090-7816_be110228-b08e-464c-b97f-4f7474cca220
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pramipexole Dihydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA090865
- Marketing category
- ANDA
- Marketing start
- 2010-10-08
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pramipexole Dihydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PRAMIPEXOLE DIHYDROCHLORIDE | 1.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3D867NP06J |
| Rxcui | 859048 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-7816-0 | Pramipexole Dihydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-7816-0 | 50090781600 | 90 TABLET in 1 BOTTLE (50090-7816-0) | 90 tablet | 2025-12-10 | No | No | Historical |