Prescription drug · ANDA
Pramipexole Dihydrochloride NDC 57237-184
Pramipexole dihydrochloride 1 mg/1 · Tablet · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57237-184-90 | 57237018490 | 90 TABLET in 1 BOTTLE (57237-184-90)Marketed from Oct 26, 2012 | |
| 57237-184-99 | 57237018499 | 1000 TABLET in 1 BOTTLE (57237-184-99)Marketed from Oct 26, 2012 |
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 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202633
- Marketing start
- Listing expires
- Other FDA classes
- Dopamine Agonists (Mechanism)
- Identifiers
- Product ID 57237-184_967cfcd5-d04f-4637-a364-632bf7ca72b8SPL ID 967cfcd5-d04f-4637-a364-632bf7ca72b8SPL set ID 56e8d1f6-6dbf-4e11-a177-a56bbfb9f8ecRxCUI 858625, 859033, 859040, 859044, 859048, 859052UNII 3D867NP06JUPC 0357237182901, 0357237180907, 0357237181904
- 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
N457237018490followed by a unit qualifier and the quantityPackage 57237-0184-90. 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 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 202633
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 | Rising Pharma Holdings, Inc. | 57237-183 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .125 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 57237-180 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .25 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 57237-181 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .5 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 57237-182 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride 1.5 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 57237-185 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .125 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-604 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .25 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-605 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride 1.5 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-609 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .5 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-606 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .75 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-607 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride 1 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-608 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride 1 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8289 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1808 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .25 mg/1 | TabletOral | A-S Medication Solutions | 50090-3280 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .25 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1877 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride 1.5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1504 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .125 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1537 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .5 mg/1 | TabletOral | A-S Medication Solutions | 50090-2455 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride 1.5 mg/1 | TabletOral | A-S Medication Solutions | 50090-5036 |