Darifenacin Hydrobromide
- Product NDC
- 10370-171
- 11-digit product format
- 103700171
- Labeler code
- 10370
- Product ID
- 10370-171_eb3fd9ee-dfb4-443d-8c9e-0635a658ed8e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Darifenacin Hydrobromide
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Par Pharmaceutical, Inc.
- Application
- ANDA091190
- Marketing category
- ANDA
- Marketing start
- 2016-03-15
- Marketing end
- 2021-02-28
- 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 |
|---|
| 10370-171-09 | 10370017109 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (10370-171-09) | 2016-03-15 | 2021-02-28 | No | No | Current |
| 10370-171-11 | 10370017111 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (10370-171-11) | 2016-03-15 | 2021-02-28 | No | No | Current |