ROPINIROLE HYDROCHLORIDE
- Product NDC
- 64679-175
- 11-digit product format
- 646790175
- Labeler code
- 64679
- Product ID
- 64679-175_e5aa4d3e-9925-4d24-93ed-69a16f88601c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ropinirole hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Wockhardt USA LLC.
- Application
- ANDA079050
- Marketing category
- ANDA
- Marketing start
- 2008-05-29
- Marketing end
- 0000-00-00
- Substance
- ROPINIROLE HYDROCHLORIDE
- Active strength
- 4 mg/1
- Pharmacologic classes
- Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 64679-175-01 | 2024-11-15 | C162847 | 48780-1 | 9d75b9d1-1dd6-f424-e053-dadaa90a57ce | 0fa94d3d-ec03-4eb7-93b2-8e1d7ff6c3e0 |
| 64679-175-02 | 2024-11-15 | C162847 | 48780-1 | 9d75b9d1-1dd6-f424-e053-dadaa90a57ce | 0fa94d3d-ec03-4eb7-93b2-8e1d7ff6c3e0 |
| 64679-175-03 | 2024-11-15 | C162847 | 48780-1 | 9d75b9d1-1dd6-f424-e053-dadaa90a57ce | 0fa94d3d-ec03-4eb7-93b2-8e1d7ff6c3e0 |
| 64679-175-04 | 2024-11-15 | C162847 | 48780-1 | 9d75b9d1-1dd6-f424-e053-dadaa90a57ce | 0fa94d3d-ec03-4eb7-93b2-8e1d7ff6c3e0 |
| 64679-175-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-1dd6-f424-e053-dadaa90a57ce | 0fa94d3d-ec03-4eb7-93b2-8e1d7ff6c3e0 |
| 64679-175-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-1dd6-f424-e053-dadaa90a57ce | 0fa94d3d-ec03-4eb7-93b2-8e1d7ff6c3e0 |
| 64679-175-03 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-1dd6-f424-e053-dadaa90a57ce | 0fa94d3d-ec03-4eb7-93b2-8e1d7ff6c3e0 |
| 64679-175-04 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-1dd6-f424-e053-dadaa90a57ce | 0fa94d3d-ec03-4eb7-93b2-8e1d7ff6c3e0 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 64679-175-02 | EA - Each | 64679-175 | df4f3a3a-08b4-4f6a-969f-b66e20449c66 | 1 | 2012-07-24 |