Prescription drug · ANDA
Pramipexole Dihydrochloride NDC 60687-570
Pramipexole dihydrochloride .25 mg/1 · Tablet · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60687-570-01 | 60687057001 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-570-01) / 1 TABLET in 1 BLISTER PACK (60687-570-11)Marketed from Aug 18, 2020 |
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
- Labeler
- American Health Packaging
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090865
- Marketing start
- Listing expires
- Other FDA classes
- Dopamine Agonists (Mechanism)
- Identifiers
- Product ID 60687-570_4c252238-7629-b19d-e063-6294a90a4c38SPL ID 4c252238-7629-b19d-e063-6294a90a4c38SPL set ID f4d97c2e-f447-4cfe-b9d4-852323f0cfb5RxCUI 859040, 859044, 859052UNII 3D867NP06J
- 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
N460687057001followed by a unit qualifier and the quantityPackage 60687-0570-01. 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 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 090865
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 | Torrent Pharmaceuticals Limited | 13668-184 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .5 mg/1 | TabletOral | American Health Packaging | 60687-581 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride 1 mg/1 | TabletOral | American Health Packaging | 60687-592 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride 1 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2167 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .25 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-5013 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .125 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-5042 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0584 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .75 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2569 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride 1.5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7816 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .25 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6704 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .25 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-092 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .125 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-091 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .5 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-093 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride 1 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-094 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride 1.5 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-095 |