Darifenacin
- Product NDC
- 0591-4380
- 11-digit product format
- 005914380
- Labeler code
- 0591
- Product ID
- 0591-4380_63338283-ed86-4dac-a4c5-50f75db9e220
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- darifenacin
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- NDA021513
- Marketing category
- NDA
- Marketing start
- 2016-03-15
- Marketing end
- 2021-05-31
- 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
- 0000-00-00
- 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 |
|---|
| 0591-4380-30 | 00591438030 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0591-4380-30) | 2016-03-15 | 2021-05-31 | No | No | Current |