DARIFENACIN
- Product NDC
- 46708-224
- 11-digit product format
- 467080224
- Labeler code
- 46708
- Product ID
- 46708-224_70d8a245-0125-4c31-b941-2137d96c43c3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DARIFENACIN
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA207681
- Marketing category
- ANDA
- Marketing start
- 2017-12-12
- 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
- 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 | 15 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | CR02EYQ8GV |
| Rxcui | 485421, 485423 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 46708-224-08 | 2023-02-01 | C162847 | 48780-1 | f386c64a-2612-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use DARIFENACIN EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DARIFENACIN EXTENDED-RELEASE TABLETS. DARIFENACIN extended-release tablets, for oral use Initial U.S. Approval: 2004 |
| 46708-224-30 | 2023-02-01 | C162847 | 48780-1 | f386c64a-2612-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use DARIFENACIN EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DARIFENACIN EXTENDED-RELEASE TABLETS. DARIFENACIN extended-release tablets, for oral use Initial U.S. Approval: 2004 |
| 46708-224-90 | 2023-02-01 | C162847 | 48780-1 | f386c64a-2612-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use DARIFENACIN EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DARIFENACIN EXTENDED-RELEASE TABLETS. DARIFENACIN extended-release tablets, for oral use Initial U.S. Approval: 2004 |
| 46708-224-91 | 2023-02-01 | C162847 | 48780-1 | f386c64a-2612-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use DARIFENACIN EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DARIFENACIN EXTENDED-RELEASE TABLETS. DARIFENACIN extended-release tablets, for oral use Initial U.S. Approval: 2004 |
| 46708-224-08 | 2023-01-30 | C162847 | 48780-1 | f386c64a-2612-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use DARIFENACIN EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DARIFENACIN EXTENDED-RELEASE TABLETS. DARIFENACIN extended-release tablets, for oral use Initial U.S. Approval: 2004 |
| 46708-224-30 | 2023-01-30 | C162847 | 48780-1 | f386c64a-2612-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use DARIFENACIN EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DARIFENACIN EXTENDED-RELEASE TABLETS. DARIFENACIN extended-release tablets, for oral use Initial U.S. Approval: 2004 |
| 46708-224-90 | 2023-01-30 | C162847 | 48780-1 | f386c64a-2612-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use DARIFENACIN EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DARIFENACIN EXTENDED-RELEASE TABLETS. DARIFENACIN extended-release tablets, for oral use Initial U.S. Approval: 2004 |
| 46708-224-91 | 2023-01-30 | C162847 | 48780-1 | f386c64a-2612-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use DARIFENACIN EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DARIFENACIN EXTENDED-RELEASE TABLETS. DARIFENACIN extended-release tablets, for oral use Initial U.S. Approval: 2004 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-224-08 | DARIFENACIN | 08 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 08 | | 3 |
| 46708-224-30 | DARIFENACIN | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 3 |
| 46708-224-90 | DARIFENACIN | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 3 |
| 46708-224-91 | DARIFENACIN | 1000 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 1000 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-224 | DARIFENACIN TABLET, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED] | 3 | Current NDC, Legacy NDC, 4 package rows | 20230202_da7c2732-232c-4e71-92d9-577ef8617f56.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 |
|---|
| 46708-224-08 | 46708022408 | 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (46708-224-08) | 2017-12-12 | 0000-00-00 | No | No | Current |
| 46708-224-30 | 46708022430 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-224-30) | 2017-12-12 | 0000-00-00 | No | No | Current |
| 46708-224-90 | 46708022490 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-224-90) | 2017-12-12 | 0000-00-00 | No | No | Current |
| 46708-224-91 | 46708022491 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-224-91) | 2017-12-12 | 0000-00-00 | No | No | Current |