Prescription drug · ANDA
pramipexole dihydrochloride NDC 64380-751
Pramipexole dihydrochloride 1.5 mg/1 · Tablet · Oral · Strides Pharma Science Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64380-751-01 | 64380075101 | 10 BLISTER PACK in 1 CARTON (64380-751-01) / 10 TABLET in 1 BLISTER PACKMarketed from Feb 15, 2021 | |
| 64380-751-05 | 64380075105 | 90 TABLET in 1 BOTTLE (64380-751-05)Marketed from Feb 15, 2021 |
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 202702
- Marketing start
- Listing expires
- Other FDA classes
- Dopamine Agonists (Mechanism)
- Identifiers
- Product ID 64380-751_411af03f-06f1-4f2c-9f51-cacfef78233bSPL ID 411af03f-06f1-4f2c-9f51-cacfef78233bSPL set ID fb2260d6-204c-4d25-a331-0f8340d83a6eRxCUI 858625, 859033, 859040, 859044, 859048, 859052UNII 3D867NP06JUPC 0364380751052, 0364380746058, 0364380750055, 0364380748052, 0364380749059, 0364380747055
- 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
N464380075101followed by a unit qualifier and the quantityPackage 64380-0751-01. 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 is 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 202702
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 | Strides Pharma Science Limited | 64380-749 |
| pramipexole dihydrochloride | Pramipexole dihydrochloride .125 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-746 |
| pramipexole dihydrochloride | Pramipexole dihydrochloride .25 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-747 |
| pramipexole dihydrochloride | Pramipexole dihydrochloride .5 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-748 |
| pramipexole dihydrochloride | Pramipexole dihydrochloride 1 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-750 |