Pramipexole Dihydrochloride
- Product NDC
- 62332-158
- 11-digit product format
- 623320158
- Labeler code
- 62332
- Product ID
- 62332-158_3e5d0f03-6a98-44eb-8bb5-366364812d50
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pramipexole Dihydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA204518
- Marketing category
- ANDA
- Marketing start
- 2019-01-03
- Substance
- PRAMIPEXOLE DIHYDROCHLORIDE
- Active strength
- 3 mg/1
- Pharmacologic classes
- Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pramipexole Dihydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PRAMIPEXOLE DIHYDROCHLORIDE | 3 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 3D867NP06J |
| Rxcui | 901534, 901541, 901546, 901550, 901555, 1114479, 1114485 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a67b8488-0225-64b1-be81-5cbe60d285a5 | Product name | 9 | 20221116 |
| 3863aae0-7028-3427-389e-3f6c8692e587 | Product name | 3 | 20190117 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 62332-158-30 | Pramipexole Dihydrochloride | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | 13 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 901541 | pramipexole dihydrochloride 0.375 MG 24HR Extended Release Oral Tablet | PSN | e18b67b6-a085-43e5-bb2b-fe74fa00cb65 | 13 |
| 901546 | pramipexole dihydrochloride 0.75 MG 24HR Extended Release Oral Tablet | PSN | e18b67b6-a085-43e5-bb2b-fe74fa00cb65 | 13 |
| 901550 | pramipexole dihydrochloride 1.5 MG 24HR Extended Release Oral Tablet | PSN | e18b67b6-a085-43e5-bb2b-fe74fa00cb65 | 13 |
| 1114479 | pramipexole dihydrochloride 2.25 MG 24HR Extended Release Oral Tablet | PSN | e18b67b6-a085-43e5-bb2b-fe74fa00cb65 | 13 |
| 901555 | pramipexole dihydrochloride 3 MG 24HR Extended Release Oral Tablet | PSN | e18b67b6-a085-43e5-bb2b-fe74fa00cb65 | 13 |
| 1114485 | pramipexole dihydrochloride 3.75 MG 24HR Extended Release Oral Tablet | PSN | e18b67b6-a085-43e5-bb2b-fe74fa00cb65 | 13 |
| 901534 | pramipexole dihydrochloride 4.5 MG 24HR Extended Release Oral Tablet | PSN | e18b67b6-a085-43e5-bb2b-fe74fa00cb65 | 13 |
| 901541 | 24 HR pramipexole dihydrochloride 0.375 MG Extended Release Oral Tablet | SCD | e18b67b6-a085-43e5-bb2b-fe74fa00cb65 | 13 |
| 901546 | 24 HR pramipexole dihydrochloride 0.75 MG Extended Release Oral Tablet | SCD | e18b67b6-a085-43e5-bb2b-fe74fa00cb65 | 13 |
| 901550 | 24 HR pramipexole dihydrochloride 1.5 MG Extended Release Oral Tablet | SCD | e18b67b6-a085-43e5-bb2b-fe74fa00cb65 | 13 |
| 1114479 | 24 HR pramipexole dihydrochloride 2.25 MG Extended Release Oral Tablet | SCD | e18b67b6-a085-43e5-bb2b-fe74fa00cb65 | 13 |
| 901555 | 24 HR pramipexole dihydrochloride 3 MG Extended Release Oral Tablet | SCD | e18b67b6-a085-43e5-bb2b-fe74fa00cb65 | 13 |
| 1114485 | 24 HR pramipexole dihydrochloride 3.75 MG Extended Release Oral Tablet | SCD | e18b67b6-a085-43e5-bb2b-fe74fa00cb65 | 13 |
| 901534 | 24 HR pramipexole dihydrochloride 4.5 MG Extended Release Oral Tablet | SCD | e18b67b6-a085-43e5-bb2b-fe74fa00cb65 | 13 |
| 901541 | pramipexole dihydrochloride 0.375 MG 24 HR Extended Release Oral Tablet | SY | e18b67b6-a085-43e5-bb2b-fe74fa00cb65 | 13 |
| 901546 | pramipexole dihydrochloride 0.75 MG 24 HR Extended Release Oral Tablet | SY | e18b67b6-a085-43e5-bb2b-fe74fa00cb65 | 13 |
| 901550 | pramipexole dihydrochloride 1.5 MG 24 HR Extended Release Oral Tablet | SY | e18b67b6-a085-43e5-bb2b-fe74fa00cb65 | 13 |
| 1114479 | pramipexole dihydrochloride 2.25 MG 24 HR Extended Release Oral Tablet | SY | e18b67b6-a085-43e5-bb2b-fe74fa00cb65 | 13 |
| 901555 | pramipexole dihydrochloride 3 MG 24 HR Extended Release Oral Tablet | SY | e18b67b6-a085-43e5-bb2b-fe74fa00cb65 | 13 |
| 1114485 | pramipexole dihydrochloride 3.75 MG 24 HR Extended Release Oral Tablet | SY | e18b67b6-a085-43e5-bb2b-fe74fa00cb65 | 13 |
| 901534 | pramipexole dihydrochloride 4.5 MG 24 HR Extended Release Oral Tablet | SY | e18b67b6-a085-43e5-bb2b-fe74fa00cb65 | 13 |
| 901546 | pramipexole dihydrochloride 750 MCG 24 HR Extended Release Oral Tablet | SY | e18b67b6-a085-43e5-bb2b-fe74fa00cb65 | 13 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 62332-158-30 | 62332015830 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-158-30) | 2019-01-03 | 0000-00-00 | No | No | Current |