Prescription drug · ANDA
Pramipexole Dihydrochloride NDC 16714-920
Pramipexole dihydrochloride 3 mg/1 · Tablet, Extended release · Oral · NorthStar RxLLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-920-01 | 16714092001 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-920-01)Marketed from Mar 6, 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 — 3 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- NorthStar RxLLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206156
- Marketing start
- Listing expires
- Other FDA classes
- Dopamine Agonists (Mechanism)
- Identifiers
- Product ID 16714-920_b78c4a9c-3ad8-443e-ada5-853385411cfcSPL ID b78c4a9c-3ad8-443e-ada5-853385411cfcSPL set ID 946c8a72-8c48-4925-93d3-7940f4c0fd29RxCUI 901534, 901541, 901546, 901550, 901555, 1114479UNII 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
N416714092001followed by a unit qualifier and the quantityPackage 16714-0920-01. 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 extended-release tablets are indicated for the treatment of Parkinson's disease. Pramipexole dihydrochloride extended-release tablets are a non-ergot dopamine agonist indicated for the treatment of Parkinson's disease (PD) ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 206156
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 .375 mg/1 | Tablet, Extended releaseOral | NorthStar RxLLC | 16714-916 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .75 mg/1 | Tablet, Extended releaseOral | NorthStar RxLLC | 16714-917 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride 1.5 mg/1 | Tablet, Extended releaseOral | NorthStar RxLLC | 16714-918 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride 2.25 mg/1 | Tablet, Extended releaseOral | NorthStar RxLLC | 16714-919 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .375 mg/1 | Tablet, Extended releaseOral | Macleods Pharmaceuticals Limited | 33342-208 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride 4.5 mg/1 | Tablet, Extended releaseOral | NorthStar RxLLC | 16714-922 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride 3 mg/1 | Tablet, Extended releaseOral | Macleods Pharmaceuticals Limited | 33342-212 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .75 mg/1 | Tablet, Extended releaseOral | Macleods Pharmaceuticals Limited | 33342-209 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride 1.5 mg/1 | Tablet, Extended releaseOral | Macleods Pharmaceuticals Limited | 33342-210 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride 2.25 mg/1 | Tablet, Extended releaseOral | Macleods Pharmaceuticals Limited | 33342-211 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride 3.75 mg/1 | Tablet, Extended releaseOral | Macleods Pharmaceuticals Limited | 33342-213 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride 4.5 mg/1 | Tablet, Extended releaseOral | Macleods Pharmaceuticals Limited | 33342-214 |