PRAMIPEXOLE
- Product NDC
- 31722-908
- 11-digit product format
- 317220908
- Labeler code
- 31722
- Product ID
- 31722-908_540a17f8-b64d-41e1-a96b-d55bc8c48f3d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PRAMIPEXOLE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA203855
- Marketing category
- ANDA
- Marketing start
- 2015-08-01
- Substance
- PRAMIPEXOLE DIHYDROCHLORIDE
- Active strength
- .5 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PRAMIPEXOLE DIHYDROCHLORIDE | .5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3D867NP06J |
| Rxcui | 858625, 859033, 859040, 859044, 859048, 859052 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 31722-908-05 | PRAMIPEXOLE | 500 in 1 BOTTLE | TABLET | 500 | | 4 |
| 31722-908-10 | PRAMIPEXOLE | 1000 in 1 BOTTLE | TABLET | 1000 | | 4 |
| 31722-908-90 | PRAMIPEXOLE | 90 in 1 BOTTLE | TABLET | 90 | | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PRAMIPEXOLE DIHYDROCHLORIDE | ACTIVE INGREDIENT | 3D867NP06J | PRAMIPEXOLE TABLET [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| PRAMIPEXOLE | ACTIVE MOIETY | 83619PEU5T | PRAMIPEXOLE TABLET [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | PRAMIPEXOLE TABLET [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PRAMIPEXOLE TABLET [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | PRAMIPEXOLE TABLET [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | PRAMIPEXOLE TABLET [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | PRAMIPEXOLE TABLET [CAMBER PHARMACEUTICALS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-908 | PRAMIPEXOLE TABLET [CAMBER PHARMACEUTICALS, INC.] | 4 | Current NDC, Legacy NDC, 3 package rows | 20161129_a7405a56-de1c-4875-b57f-210c991474ba.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 31722-908-05 | 31722090805 | 500 TABLET in 1 BOTTLE (31722-908-05) | 500 tablet | 2015-08-01 | 0000-00-00 | No | No | Current |
| 31722-908-10 | 31722090810 | 1000 TABLET in 1 BOTTLE (31722-908-10) | 1000 tablet | 2015-08-01 | 0000-00-00 | No | No | Current |
| 31722-908-90 | 31722090890 | 90 TABLET in 1 BOTTLE (31722-908-90) | 90 tablet | 2015-08-01 | 0000-00-00 | No | No | Current |