Prescription drug · ANDA
Pramipexole Dihydrochloride NDC 46708-615
Pramipexole dihydrochloride 1.5 mg/1 · Tablet · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-615-90 | 46708061590 | 90 TABLET in 1 BOTTLE (46708-615-90)Marketed from Mar 22, 2016 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Pramipexole Dihydrochloride
- Generic name (nonproprietary)
- pramipexole dihydrochloride
- Active ingredients
- Pramipexole dihydrochloride — 1.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078894
- Marketing start
- Listing expires
- Other FDA classes
- Dopamine Agonists (Mechanism)
- Identifiers
- Product ID 46708-615_43b3cc2f-5e67-4440-a896-69f9be384e33SPL ID 43b3cc2f-5e67-4440-a896-69f9be384e33SPL set ID 0a3ed933-ef5b-4091-8ae9-5768ae18514fRxCUI 859033, 859040, 859044, 859048, 859052UNII 3D867NP06JUPC 0346708614904, 0346708615901, 0346708613907, 0346708611903
- Pharmacologic class
- Nonergot Dopamine Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N446708061590followed by a unit qualifier and the quantityPackage 46708-0615-90. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Pramipexole dihydrochloride tablets are non-ergot dopamine agonist indicated for the treatment of: · Parkinson’s disease (PD) (1.1) 1.1 Parkinson's Disease Pramipexole dihydrochloride tablets are indicated for the treatment of Parkinson’s disease.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078894
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .25 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-612 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .125 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-611 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .5 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-613 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride 1 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-614 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .125 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-003 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .25 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-004 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .5 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-005 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride 1 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-006 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride 1.5 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-007 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .5 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-005 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .125 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-003 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .25 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-004 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride 1 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-006 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride 1.5 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-007 |