Prescription drug · ANDA
pramipexole dihydrochloride NDC 29300-207
Pramipexole dihydrochloride .125 mg/1 · Tablet · Oral · Unichem Pharmaceuticals (USA), Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 29300-207-10 | 29300020710 | 1000 TABLET in 1 BOTTLE, PLASTIC (29300-207-10)Marketed from Mar 1, 2019 | |
| 29300-207-16 | 29300020716 | 60 TABLET in 1 BOTTLE, PLASTIC (29300-207-16)Marketed from Mar 1, 2019 | |
| 29300-207-19 | 29300020719 | 90 TABLET in 1 BOTTLE, PLASTIC (29300-207-19)Marketed from Mar 1, 2019 |
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 — .125 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207011
- Marketing start
- Listing expires
- Other FDA classes
- Dopamine Agonists (Mechanism)
- Identifiers
- Product ID 29300-207_2ab8bb44-e4ba-4ae0-8ce9-0e9153de59f3SPL ID 2ab8bb44-e4ba-4ae0-8ce9-0e9153de59f3SPL set ID b978aa75-c62d-444b-9ec6-6c0d21a66688RxCUI 858625, 859033, 859040, 859044, 859048, 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
N429300020710followed by a unit qualifier and the quantityPackage 29300-0207-10. 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
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 207011
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 1.5 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-211 |
| pramipexole dihydrochloride | Pramipexole dihydrochloride .25 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-208 |
| pramipexole dihydrochloride | Pramipexole dihydrochloride .5 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-209 |
| pramipexole dihydrochloride | Pramipexole dihydrochloride 1 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-210 |
| pramipexole dihydrochloride | Pramipexole dihydrochloride .75 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-270 |