Prescription drug · ANDA
Pramipexole Dihydrochloride Extended-Release (Pramipexole dihydrochloride) NDC 71034-003
Pramipexole dihydrochloride .75 mg/1 · Tablet, Extended release · Oral · Xiamen LP Pharmaceutical Co., Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71034-003-30 | 71034000330 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71034-003-30)Marketed from Jun 11, 2021 |
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 Extended-ReleaseSuffix: Extended-Release
- Generic name (nonproprietary)
- pramipexole dihydrochloride
- Active ingredients
- Pramipexole dihydrochloride — .75 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Xiamen LP Pharmaceutical Co., Ltd.NDC labeler code 71034
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212797
- Marketing start
- Listing expires
- Other FDA classes
- Dopamine Agonists (Mechanism)
- Identifiers
- Product ID 71034-003_c4ddb97d-cba5-9f6b-e053-2a95a90a4956SPL ID c4ddb97d-cba5-9f6b-e053-2a95a90a4956SPL set ID 1cbd8ddf-4fc1-4cd0-906d-a55a4b8b1c3cRxCUI 901541, 901546UNII 3D867NP06JUPC 0371034003306, 0371034002309
- 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
N471034000330followed by a unit qualifier and the quantityPackage 71034-0003-30. 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.
About NDC 71034-003
- What is NDC 71034-003?
- 71034-003 is the product NDC for Pramipexole Dihydrochloride Extended-Release, Pramipexole dihydrochloride .75 mg/1 tablet, extended release, listed with the FDA by Xiamen LP Pharmaceutical Co., Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pramipexole Dihydrochloride Extended-Release (Pramipexole Dihydrochloride).
- What is the active ingredient?
- Pramipexole dihydrochloride.
- Who is the labeler?
- Xiamen LP Pharmaceutical Co., Ltd., NDC labeler code 71034. 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 Extended-Release?
- 2 other product NDCs are listed under this name. See all Pramipexole Dihydrochloride Extended-Release 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 Extended-Release 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 Extended-Releasepramipexole dihydrochloride | Pramipexole dihydrochloride .375 mg/1 | Tablet, Extended releaseOral | Vitruvias Therapeutics, Inc. | 69680-145 | 69680-0145-30 |
| Pramipexole Dihydrochloride Extended-Releasepramipexole dihydrochloride | Pramipexole dihydrochloride .375 mg/1 | Tablet, Extended releaseOral | Xiamen LP Pharmaceutical Co., Ltd. | 71034-002 | 71034-0002-30 |
Other NDCs under ANDA 212797
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 | Tablet, Extended releaseOral | Vitruvias Therapeutics, Inc. | 69680-146 |
| Pramipexole Dihydrochloride Extended-Releasepramipexole dihydrochloride | Pramipexole dihydrochloride .375 mg/1 | Tablet, Extended releaseOral | Vitruvias Therapeutics, Inc. | 69680-145 |
| Pramipexole Dihydrochloride Extended-Releasepramipexole dihydrochloride | Pramipexole dihydrochloride .375 mg/1 | Tablet, Extended releaseOral | Xiamen LP Pharmaceutical Co., Ltd. | 71034-002 |