Pramipexole Dihydrochloride
- Product NDC
- 0904-6704
- 11-digit product format
- 009046704
- Labeler code
- 0904
- Product ID
- 0904-6704_9ad8df87-b8f1-4a39-a391-d7f7548de896
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pramipexole Dihydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA090865
- Marketing category
- ANDA
- Marketing start
- 2010-10-08
- Substance
- PRAMIPEXOLE DIHYDROCHLORIDE
- Active strength
- .25 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 | .25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3D867NP06J |
| Rxcui | 859040 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-6704-61 | Pramipexole Dihydrochloride | 1 in 1 BLISTER PACK | TABLET | 1 | | 10 |
| 0904-6704-61 | Pramipexole Dihydrochloride | 100 in 1 CARTON | TABLET | 100 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-6704 | PRAMIPEXOLE DIHYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS] | 7 | Current NDC, Legacy NDC, 2 package rows | 20250424_978c0e89-35f0-44a2-9302-8bed7e5d60e0.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 |
|---|
| 0904-6704-61 | 00904670461 | 100 BLISTER PACK in 1 CARTON (0904-6704-61) / 1 TABLET in 1 BLISTER PACK | 100 blister pack | 2010-10-08 | 0000-00-00 | No | No | Current |