Pramipexole Dihydrochloride
- Product NDC
- 46708-004
- 11-digit product format
- 467080004
- Labeler code
- 46708
- Product ID
- 46708-004_92f6ef1e-3256-45a7-a409-80dd85e95187
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pramipexole Dihydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA078894
- Marketing category
- ANDA
- Marketing start
- 2016-03-22
- Substance
- PRAMIPEXOLE DIHYDROCHLORIDE
- Active strength
- .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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pramipexole Dihydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PRAMIPEXOLE DIHYDROCHLORIDE | .25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3D867NP06J |
| Rxcui | 859033, 859040, 859044, 859048, 859052 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-004-90 | Pramipexole Dihydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-004 | PRAMIPEXOLE DIHYDROCHLORIDE TABLET [ALEMBIC PHARMACEUTICALS LIMITED] | 1 | Current NDC, Legacy NDC, 1 package rows | 20171218_92f6ef1e-3256-45a7-a409-80dd85e95187.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 46708-004-90 | 46708000490 | 90 TABLET in 1 BOTTLE (46708-004-90) | 90 tablet | 2016-03-22 | 0000-00-00 | No | No | Current |