Pramipexole dihydrochloride
- Product NDC
- 0615-8552
- 11-digit product format
- 006158552
- Labeler code
- 0615
- Product ID
- 0615-8552_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
- .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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 3D867NP06J | PRAMIPEXOLE DIHYDROCHLORIDE | 191217-81-9 | PRAMIPEXOLE DIHYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0615-8552-39 | 00615855239 | 30 TABLET in 1 BLISTER PACK (0615-8552-39) | 30 tablet | 2024-10-08 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Pramipexole dihydrochloride | NCS HealthCare of KY, LLC dba Vangard Labs | 2024-10-09 | HUMAN PRESCRIPTION DRUG LABEL | 1 |