Prescription drug · ANDA
Pramipexole Dihydrochloride NDC 62332-154
Pramipexole dihydrochloride .375 mg/1 · Tablet, Extended release · Oral · Alembic Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62332-154-30 | 62332015430 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-154-30)Marketed from Jan 3, 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 — .375 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204518
- Marketing start
- Listing expires
- Other FDA classes
- Dopamine Agonists (Mechanism)
- Identifiers
- Product ID 62332-154_3e5d0f03-6a98-44eb-8bb5-366364812d50SPL ID 3e5d0f03-6a98-44eb-8bb5-366364812d50SPL set ID e18b67b6-a085-43e5-bb2b-fe74fa00cb65RxCUI 901534, 901541, 901546, 901550, 901555, 1114479, 1114485UNII 3D867NP06JUPC 0362332154302, 0362332155309, 0362332158300, 0362332156306, 0362332160303, 0362332157303, 0362332159307
- 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
N462332015430followed by a unit qualifier and the quantityPackage 62332-0154-30. 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 is 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 204518
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 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-576 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride 2.25 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-577 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride 3 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-578 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .75 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-575 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .375 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-574 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride 4.5 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Inc. | 62332-159 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride 3.75 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Inc. | 62332-160 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride 3 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Inc. | 62332-158 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride 3.75 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-579 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride .75 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Inc. | 62332-155 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride 4.5 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-580 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride 1.5 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Inc. | 62332-156 |
| Pramipexole Dihydrochloride | Pramipexole dihydrochloride 2.25 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Inc. | 62332-157 |