darifenacin
- Product NDC
- 59746-517
- 11-digit product format
- 597460517
- Labeler code
- 59746
- Product ID
- 59746-517_7ed533b1-0dcb-4ed4-a702-d998183568a0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- darifenacin hydrobromide
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Jubilant Cadista Pharmaceuticals Inc.
- Application
- ANDA205550
- Marketing category
- ANDA
- Marketing start
- 2016-10-12
- Marketing end
- 0000-00-00
- Substance
- DARIFENACIN HYDROBROMIDE
- Active strength
- 15 mg/1
- Pharmacologic classes
- Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
- 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 |
|---|
| 59746-517-01 | 59746051701 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59746-517-01) | 2016-10-12 | 0000-00-00 | No | No | Current |
| 59746-517-10 | 59746051710 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (59746-517-10) | 2016-10-12 | 0000-00-00 | No | No | Current |
| 59746-517-30 | 59746051730 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (59746-517-30) | 2016-10-12 | 0000-00-00 | No | No | Current |
| 59746-517-90 | 59746051790 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (59746-517-90) | 2016-10-12 | 0000-00-00 | No | No | Current |