Darifenacin
- Product NDC
- 33342-276
- 11-digit product format
- 333420276
- Labeler code
- 33342
- Product ID
- 33342-276_2abbe156-e5ab-484c-aed7-fa4b5f06698d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Darifenacin
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA207302
- Marketing category
- ANDA
- Marketing start
- 2017-07-29
- 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 |
|---|
| 33342-276-07 | Darifenacin | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 4 |
| 33342-276-10 | Darifenacin | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 4 |
| 33342-276-12 | Darifenacin | 10 in 1 CARTON | TABLET, EXTENDED RELEASE | 10 | | 4 |
| 33342-276-12 | Darifenacin | 10 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 10 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33342-276 | DARIFENACIN TABLET, EXTENDED RELEASE [MACLEODS PHARMACEUTICALS LIMITED] | 4 | Current NDC, Legacy NDC, 4 package rows | 20230217_7ae60119-e22c-4806-a5d8-db7c9e8984a2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 33342-276-07 | 33342027607 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-276-07) | | 2017-07-29 | 0000-00-00 | No | No | Current |
| 33342-276-10 | 33342027610 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-276-10) | | 2017-07-29 | 0000-00-00 | No | No | Current |
| 33342-276-12 | 33342027612 | 10 BLISTER PACK in 1 CARTON (33342-276-12) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 10 blister pack | 2017-07-29 | 0000-00-00 | No | No | Current |