ropinirole hydrochloride
- Product NDC
- 43353-198
- 11-digit product format
- 433530198
- Labeler code
- 43353
- Product ID
- 43353-198_f70e20d8-079c-48fa-9dde-acc3025d487e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ropinirole hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA078110
- Marketing category
- ANDA
- Marketing start
- 2011-09-20
- Marketing end
- 0000-00-00
- Substance
- ROPINIROLE HYDROCHLORIDE
- Active strength
- 2 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
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| dc920868-8845-b908-7ca8-0dee3e345af5 | Product name | 2 | 20230123 |
| e24bc1b4-1e16-908e-3d09-29da3ca2fb1f | Product name | 2 | 20170517 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 43353-198-09 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-99a6-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use ropinirole hydrochloride tablets safely and effectively. See full prescribing information for ropinirole hydrochloride tablets. ROPINIROLE Hydrochloride Tablets, USP, film coated for oral use Initial U.S. Approval: 1997 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43353-198-09 | ropinirole hydrochloride | 9000 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 9000 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43353-198-09 | EA - Each | 43353-198 | 1916fc22-9f58-46ea-91fa-7cf9e6839708 | 1 | 2016-10-06 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312845 | rOPINIRole HCl 0.25 MG Oral Tablet | PSN | 70e6fca5-554e-48d4-9d11-9879009c4bd8 | 1 |
| 312846 | rOPINIRole HCl 0.5 MG Oral Tablet | PSN | 70e6fca5-554e-48d4-9d11-9879009c4bd8 | 1 |
| 314208 | rOPINIRole HCl 1 MG Oral Tablet | PSN | 70e6fca5-554e-48d4-9d11-9879009c4bd8 | 1 |
| 312847 | rOPINIRole HCl 2 MG Oral Tablet | PSN | 70e6fca5-554e-48d4-9d11-9879009c4bd8 | 1 |
| 312845 | ropinirole 0.25 MG Oral Tablet | SCD | 70e6fca5-554e-48d4-9d11-9879009c4bd8 | 1 |
| 312846 | ropinirole 0.5 MG Oral Tablet | SCD | 70e6fca5-554e-48d4-9d11-9879009c4bd8 | 1 |
| 314208 | ropinirole 1 MG Oral Tablet | SCD | 70e6fca5-554e-48d4-9d11-9879009c4bd8 | 1 |
| 312847 | ropinirole 2 MG Oral Tablet | SCD | 70e6fca5-554e-48d4-9d11-9879009c4bd8 | 1 |
| 312845 | ropinirole 0.25 MG (as ropinirole hydrochloride) Oral Tablet | SY | 70e6fca5-554e-48d4-9d11-9879009c4bd8 | 1 |
| 312846 | ropinirole 0.5 MG (as ropinirole hydrochloride) Oral Tablet | SY | 70e6fca5-554e-48d4-9d11-9879009c4bd8 | 1 |
| 314208 | ropinirole 1 MG (as ropinirole hydrochloride) Oral Tablet | SY | 70e6fca5-554e-48d4-9d11-9879009c4bd8 | 1 |
| 312847 | ropinirole 2 MG (as ropinirole hydrochloride) Oral Tablet | SY | 70e6fca5-554e-48d4-9d11-9879009c4bd8 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 43353-198-09 | 43353019809 | 9000 in 1 BOTTLE, PLASTIC | Historical |