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NDC 33342-0276-12 Darifenacin 7.5 mg/1 Details
Darifenacin 7.5 mg/1
Darifenacin is a ORAL TABLET, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Macleods Pharmaceuticals Limited. The primary component is DARIFENACIN HYDROBROMIDE.
MedlinePlus Drug Summary
Darifenacin is used to treat an overactive bladder (a condition in which the bladder muscles contract uncontrollably and cause frequent urination, urgent need to urinate, and inability to control urination). Darifenacin is in a class of medications called antimuscarinics. It works by relaxing the bladder muscles to prevent urgent, frequent, or uncontrolled urination.
Related Packages: 33342-0276-12Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Darifenacin
Product Information
| NDC | 33342-0276 |
|---|---|
| Product ID | 33342-276_2abbe156-e5ab-484c-aed7-fa4b5f06698d |
| Associated GPIs | 54100010207520 |
| GCN Sequence Number | 058576 |
| GCN Sequence Number Description | darifenacin hydrobromide TAB ER 24H 7.5 MG ORAL |
| HIC3 | R1I |
| HIC3 Description | URINARY TRACT ANTISPASMODIC, M(3) SELECTIVE ANTAG. |
| GCN | 24043 |
| HICL Sequence Number | 026820 |
| HICL Sequence Number Description | DARIFENACIN HYDROBROMIDE |
| Brand/Generic | Generic |
| Proprietary Name | Darifenacin |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Darifenacin |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 7.5 |
| Active Ingredient Units | mg/1 |
| Substance Name | DARIFENACIN HYDROBROMIDE |
| Labeler Name | Macleods Pharmaceuticals Limited |
| Pharmaceutical Class | Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA207302 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 33342-0276-12 (33342027612)
| NDC Package Code | 33342-276-12 |
|---|---|
| Billing NDC | 33342027612 |
| Package | 10 BLISTER PACK in 1 CARTON (33342-276-12) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| Marketing Start Date | 2017-07-29 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |