ropinirole hydrochloride
- Product NDC
- 68382-338
- 11-digit product format
- 683820338
- Labeler code
- 68382
- Product ID
- 68382-338_cc4d9bb0-3b78-4e6c-85bb-d1280da83039
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ropinirole hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals (USA) Inc.
- Application
- ANDA090411
- Marketing category
- ANDA
- Marketing start
- 2009-09-23
- Marketing end
- 0000-00-00
- Substance
- ROPINIROLE HYDROCHLORIDE
- Active strength
- 0 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
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68382-338-01 | 68382033801 | 100 TABLET, FILM COATED in 1 BOTTLE (68382-338-01) | 2009-09-23 | 0000-00-00 | No | No | Current |
| 68382-338-10 | 68382033810 | 1000 TABLET, FILM COATED in 1 BOTTLE (68382-338-10) | 2009-09-23 | 0000-00-00 | No | No | Current |