Pramipexole Dihydrochloride
- Product NDC
- 50090-5036
- 11-digit product format
- 500905036
- Labeler code
- 50090
- Product ID
- 50090-5036_32458c95-4cff-4b30-bc62-0f0b2203a584
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pramipexole Dihydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA202633
- Marketing category
- ANDA
- Marketing start
- 2012-10-26
- 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
- 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 | 1.5 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 |
|---|
| 50090-5036-0 | Pramipexole Dihydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-5036 | PRAMIPEXOLE DIHYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS] | 7 | Current NDC, Legacy NDC, 1 package rows | 20231216_7cd6a546-d516-427c-af79-555390ccd35b.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 |
|---|
| 50090-5036-0 | 50090503600 | 90 TABLET in 1 BOTTLE (50090-5036-0) | 90 tablet | 2020-05-06 | 0000-00-00 | No | No | Current |