Pramipexole Dihydrochloride
- Product NDC
- 46708-614
- 11-digit product format
- 467080614
- Labeler code
- 46708
- Product ID
- 46708-614_43b3cc2f-5e67-4440-a896-69f9be384e33
- 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
- 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
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 | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3D867NP06J |
| Rxcui | 859033, 859040, 859044, 859048, 859052 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-614-90 | Pramipexole Dihydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-614 | PRAMIPEXOLE DIHYDROCHLORIDE TABLET [ALEMBIC PHARMACEUTICALS LIMITED] | 2 | Current NDC, Legacy NDC, 1 package rows | 20231209_0a3ed933-ef5b-4091-8ae9-5768ae18514f.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 |
|---|
| 46708-614-90 | 46708061490 | 90 TABLET in 1 BOTTLE (46708-614-90) | 90 tablet | 2016-03-22 | 0000-00-00 | No | No | Current |