Prescription drug · ANDA
Pramipexole dihydrochloride NDC 68462-331
Pramipexole dihydrochloride .25 mg/1 · Tablet · Oral · Glenmark Pharmaceuticals Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-331-05 | 68462033105 | 500 TABLET in 1 BOTTLE (68462-331-05)Marketed from Oct 8, 2010 | |
| 68462-331-11 | 68462033111 | 10 BLISTER PACK in 1 CARTON (68462-331-11) / 10 TABLET in 1 BLISTER PACKMarketed from Oct 8, 2010 | |
| 68462-331-90 | 68462033190 | 90 TABLET in 1 BOTTLE (68462-331-90)Marketed from Oct 8, 2010 |
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 — .25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090781
- Marketing start
- Listing expires
- Other FDA classes
- Dopamine Agonists (Mechanism)
- Identifiers
- Product ID 68462-331_75644134-fcad-4dde-8a22-453d18472002SPL ID 75644134-fcad-4dde-8a22-453d18472002SPL set ID 44c336d2-01d1-4f13-bad9-549cdc3505ecRxCUI 858625, 859033, 859040, 859044, 859048, 859052UNII 3D867NP06JUPC 0368462332900, 0368462333907, 0368462334904, 0368462331903, 0368462627907, 0368462330906
- 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
N468462033105followed by a unit qualifier and the quantityPackage 68462-0331-05. 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 a non-ergot dopamine agonist indicated for the treatment of: • Parkinson’s disease (PD) ( 1.1 ) • Moderate-to-severe primary Restless Legs Syndrome (RLS) ( 1.2 ) 1.1 Parkinson's Disease Pramipexole dihydrochloride tablets are indicated for the treatment of Parkinson's disease. 1.2 Restless Legs Syndrome Pramipexole dihydrochloride tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090781
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 .75 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-627 |
| Pramipexole dihydrochloride | Pramipexole dihydrochloride .25 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8551 |
| Pramipexole dihydrochloride | Pramipexole dihydrochloride .5 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8552 |
| Pramipexole dihydrochloride | Pramipexole dihydrochloride .125 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-330 |
| Pramipexole dihydrochloride | Pramipexole dihydrochloride .5 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-332 |
| Pramipexole dihydrochloride | Pramipexole dihydrochloride 1 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-333 |
| Pramipexole dihydrochloride | Pramipexole dihydrochloride 1.5 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-334 |