Pramipexole Dihydrochloride
- Product NDC
- 0781-5248
- 11-digit product format
- 007815248
- Labeler code
- 0781
- Product ID
- 0781-5248_57121d70-d083-4862-b4e5-c69e12067089
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pramipexole Dihydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Sandoz Inc
- Application
- ANDA090190
- Marketing category
- ANDA
- Marketing start
- 2010-07-06
- Marketing end
- 0000-00-00
- Substance
- PRAMIPEXOLE DIHYDROCHLORIDE
- Active strength
- 0 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
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0781-5248-13 | 2021-04-09 | C162847 | 48780-1 | 9d75b9cf-f2bd-f424-e053-dadaa90a57ce | 5ce35518-5319-43f8-ab1a-31e3c612631e |
| 0781-5248-92 | 2021-04-09 | C162847 | 48780-1 | 9d75b9cf-f2bd-f424-e053-dadaa90a57ce | 5ce35518-5319-43f8-ab1a-31e3c612631e |
| 0781-5248-13 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-f2bd-f424-e053-dadaa90a57ce | 5ce35518-5319-43f8-ab1a-31e3c612631e |
| 0781-5248-92 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-f2bd-f424-e053-dadaa90a57ce | 5ce35518-5319-43f8-ab1a-31e3c612631e |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0781-5248-92 | EA - Each | 0781-5248 | 4a1a53f8-0e44-4149-b9b5-5abb23641e10 | 1 | 2012-07-24 |