Prescription drug · ANDA
Pramipexole Dihydrochloride NDC 50228-127
Pramipexole dihydrochloride .25 mg/1 · Tablet · Oral · ScieGen Pharmaceuticals Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50228-127-10 | 50228012710 | 1000 TABLET in 1 BOTTLE (50228-127-10)Marketed from Oct 29, 2014 | |
| 50228-127-90 | 50228012790 | 90 TABLET in 1 BOTTLE (50228-127-90)Marketed from Oct 29, 2014 |
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
- ScieGen Pharmaceuticals Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203855
- Marketing start
- Listing expires
- Other FDA classes
- Dopamine Agonists (Mechanism)
- Identifiers
- Product ID 50228-127_14260a48-c15f-4517-9ce5-d26928b6a5f5SPL ID 14260a48-c15f-4517-9ce5-d26928b6a5f5SPL set ID 395fee34-43dc-4840-a6b8-70d5736f9c8bRxCUI 858625, 859033, 859040, 859044, 859048, 859052UNII 3D867NP06JUPC 0350228131902, 0350228126106, 0350228129107, 0350228130103
- 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
N450228012710followed by a unit qualifier and the quantityPackage 50228-0127-10. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 203855
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 .125 mg/1 | TabletOral | ScieGen Pharmaceuticals Inc | 50228-126 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .5 mg/1 | TabletOral | ScieGen Pharmaceuticals Inc | 50228-128 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .75 mg/1 | TabletOral | ScieGen Pharmaceuticals Inc | 50228-129 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride 1 mg/1 | TabletOral | ScieGen Pharmaceuticals Inc | 50228-130 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride 1.5 mg/1 | TabletOral | ScieGen Pharmaceuticals Inc | 50228-131 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .5 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 60429-087 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .125 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 60429-085 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .25 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 60429-086 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .75 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 60429-088 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride 1 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 60429-089 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride 1.5 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 60429-090 |
| Pramipexole | Pramipexole dihydrochloride .125 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-906 |
| Pramipexole | Pramipexole dihydrochloride .75 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-909 |
| Pramipexole | Pramipexole dihydrochloride .25 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-907 |
| Pramipexole | Pramipexole dihydrochloride .5 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-908 |
| Pramipexole | Pramipexole dihydrochloride 1 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-910 |
| Pramipexole | Pramipexole dihydrochloride 1.5 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-911 |