Pramipexole Dihydrochloride
- Product NDC
- 71335-1537
- 11-digit product format
- 713351537
- Labeler code
- 71335
- Product ID
- 71335-1537_29f9b38b-000e-4f65-8e28-3c77c3caaa76
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pramipexole Dihydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- 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
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 | .125 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3D867NP06J |
| Rxcui | 859033 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-1537-1 | Pramipexole Dihydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 102 |
| 71335-1537-2 | Pramipexole Dihydrochloride | 60 in 1 BOTTLE | TABLET | 60 | | 102 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-1537 | PRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] | 102 | Current NDC, Legacy NDC, 2 package rows | 20240410_468830df-941c-4363-b432-94de9b7fd2ac.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 |
|---|
| 71335-1537-1 | 71335153701 | 30 TABLET in 1 BOTTLE (71335-1537-1) | 30 tablet | 2020-03-16 | 0000-00-00 | No | No | Current |
| 71335-1537-2 | 71335153702 | 60 TABLET in 1 BOTTLE (71335-1537-2) | 60 tablet | 2021-11-23 | 0000-00-00 | No | No | Current |