Pramipexole dihydrochloride
- Product NDC
- 0615-8551
- 11-digit product format
- 006158551
- Labeler code
- 0615
- Product ID
- 0615-8551_7d36ceb3-2235-42bc-bb8c-e7863c24b1cb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pramipexole dihydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA090781
- 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
- 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 | 859040, 859044 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-8551-39 | Pramipexole dihydrochloride | 30 in 1 BLISTER PACK | TABLET | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8551 | PRAMIPEXOLE DIHYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 1 | Current NDC, 1 package rows | 20241011_5e6f2187-a5cc-481e-b0a1-d38d3f92e822.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0615-8551-39 | 00615855139 | 30 TABLET in 1 BLISTER PACK (0615-8551-39) | 30 tablet | 2024-10-07 | No | No | Current |