Ropinirole Hydrochloride
- Product NDC
- 43353-265
- 11-digit product format
- 433530265
- Labeler code
- 43353
- Product ID
- 43353-265_137b8563-7235-4e5b-bcdf-68e788eb8d8b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ropinirole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA078881
- Marketing category
- ANDA
- Marketing start
- 2016-06-20
- Marketing end
- 0000-00-00
- Substance
- ROPINIROLE HYDROCHLORIDE
- Active strength
- 1 mg/1
- Pharmacologic classes
- Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-265 | ROPINIROLE HYDROCHLORIDE (ROPINIROLE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Legacy NDC | 20171005_471a4163-9b09-425c-8736-961d26ab11c3.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43353-265-09 | 43353026509 | 9000 TABLET in 1 BOTTLE, PLASTIC (43353-265-09) | 9000 tablet | 2016-12-01 | 0000-00-00 | No | No | Current |