Pramipexole Dihydrochloride
- Product NDC
- 68151-3645
- 11-digit product format
- 681513645
- Labeler code
- 68151
- Product ID
- 68151-3645_a8261a2f-3381-4684-b33d-f84fec00bf26
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pramipexole Dihydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Carilion Materials Management
- Application
- ANDA090865
- Marketing category
- ANDA
- Marketing start
- 2010-10-08
- Marketing end
- 0000-00-00
- Substance
- PRAMIPEXOLE DIHYDROCHLORIDE
- Active strength
- 1 mg/1
- Pharmacologic classes
- Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68151-3645-9 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-a531-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use Pramipexole Dihydrochloride Tablets safely and effectively. See full prescribing information for pramipexole dihydrochloride tablets. PRAMIPEXOLE dihydrochloride tablets, for oral use Initial U.S. Approval: 1997 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68151-3645-9 | Pramipexole Dihydrochloride | 1 in 1 PACKAGE | TABLET | 1 | 4 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| PRAMIPEXOLE DIHYDROCHLORIDE | ACTIVE INGREDIENT | 3D867NP06J | PRAMIPEXOLE DIHYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT] | 3 | |
| PRAMIPEXOLE | ACTIVE MOIETY | 83619PEU5T | PRAMIPEXOLE DIHYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT] | 3 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | PRAMIPEXOLE DIHYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PRAMIPEXOLE DIHYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT] | 3 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | PRAMIPEXOLE DIHYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT] | 3 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | PRAMIPEXOLE DIHYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | PRAMIPEXOLE DIHYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | PRAMIPEXOLE DIHYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT] | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68151-3645 | PRAMIPEXOLE DIHYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT] | 4 | Legacy NDC, 1 package rows | 20160806_cf89d9ae-decf-4078-8c97-59a6f199ad24.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 859052 | pramipexole dihydrochloride 1 MG Oral Tablet | PSN | cf89d9ae-decf-4078-8c97-59a6f199ad24 | 4 |
| 859052 | pramipexole dihydrochloride 1 MG Oral Tablet | SCD | cf89d9ae-decf-4078-8c97-59a6f199ad24 | 4 |
| 859052 | pramipexole dihydrochloride 1 MG (pramipexole 0.7 MG) Oral Tablet | SY | cf89d9ae-decf-4078-8c97-59a6f199ad24 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 68151-3645-9 | 68151364509 | 1 in 1 PACKAGE | Historical |