Darifenacin
- Product NDC
- 52605-067
- 11-digit product format
- 526050067
- Labeler code
- 52605
- Product ID
- 52605-067_46abf1bc-3aaf-4d26-8f2b-b0340e9b32e4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Darifenacin Hydrobromide
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- POLYGEN PHARMACEUTICALS INC.
- Application
- ANDA211045
- Marketing category
- ANDA
- Marketing start
- 2020-12-01
- Substance
- DARIFENACIN HYDROBROMIDE
- Active strength
- 7.5 mg/1
- Pharmacologic classes
- Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Darifenacin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DARIFENACIN HYDROBROMIDE | 7.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | CR02EYQ8GV |
| Rxcui | 485421, 485423 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 52605-067-10 | Darifenacin | 1000 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 1000 | | 3 |
| 52605-067-19 | Darifenacin | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52605-067 | DARIFENACIN (DARIFENACIN HYDROBROMIDE) TABLET, EXTENDED RELEASE [POLYGEN PHARMACEUTICALS INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20221214_62a72d3e-3c33-4f2d-b3d0-2e014f704c63.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 52605-067-10 | 52605006710 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (52605-067-10) | 2020-12-01 | 0000-00-00 | No | No | Current |
| 52605-067-19 | 52605006719 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (52605-067-19) | 2020-12-01 | 0000-00-00 | No | No | Current |