Prescription drug · ANDA
Pramipexole Dihydrochloride NDC 63629-5042
Pramipexole dihydrochloride .125 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-5042-1 | 6362950420163629504201 | 30 TABLET in 1 BOTTLE (63629-5042-1)Marketed from Jul 16, 2013 | |
| 63629-5042-2 | 6362950420263629504202 | 60 TABLET in 1 BOTTLE (63629-5042-2)Marketed from Sep 10, 2013 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- 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 63629-5042_c2a84c54-b4d7-4989-9bb9-21a523d0a938SPL ID c2a84c54-b4d7-4989-9bb9-21a523d0a938SPL set ID bd0f7ae1-11ef-4fab-894f-c4c59f75aa99RxCUI 859033UNII 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
N463629504201followed by a unit qualifier and the quantityPackage 63629-5042-01. 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 tablets are 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.
About NDC 63629-5042
- What is NDC 63629-5042?
- 63629-5042 is the product NDC for Pramipexole Dihydrochloride, Pramipexole dihydrochloride .125 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pramipexole Dihydrochloride.
- What is the active ingredient?
- Pramipexole dihydrochloride.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 63629. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pramipexole Dihydrochloride?
- 127 other product NDCs are listed under this name. See all Pramipexole Dihydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pramipexole Dihydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Pramipexole dihydrochloride | Pramipexole dihydrochloride .375 mg/1 | Tablet, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-331 | 50742-0331-30 |
| Pramipexole dihydrochloride | Pramipexole dihydrochloride 2.25 mg/1 | Tablet, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-334 | 50742-0334-30 |
| Pramipexole dihydrochloride | Pramipexole dihydrochloride .75 mg/1 | Tablet, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-332 | 50742-0332-30 |
| Pramipexole dihydrochloride | Pramipexole dihydrochloride 1.5 mg/1 | Tablet, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-333 | 50742-0333-30 |
| Pramipexole dihydrochloride | Pramipexole dihydrochloride 3 mg/1 | Tablet, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-335 | 50742-0335-30 |
| Pramipexole dihydrochloride | Pramipexole dihydrochloride 3.75 mg/1 | Tablet, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-336 | 50742-0336-30 |
| Pramipexole dihydrochloride | Pramipexole dihydrochloride 4.5 mg/1 | Tablet, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-337 | 50742-0337-30 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .75 mg/1 | Tablet, Extended releaseOral | Vitruvias Therapeutics, Inc. | 69680-146 | 69680-0146-30 |
| pramipexole dihydrochloride | Pramipexole dihydrochloride .125 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-746 | 64380-0746-05 |
| pramipexole dihydrochloride | Pramipexole dihydrochloride 1 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-750 | 64380-0750-0164380-0750-05 |
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 .25 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6704 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .125 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-091 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .25 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-092 |
| 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 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .75 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-184 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride 1.5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7816 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .25 mg/1 | TabletOral | American Health Packaging | 60687-570 |
| 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 .25 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-5013 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0584 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride 1 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2167 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .75 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2569 |