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NDC 65862-0878-03 Solifenacin Succinate 5 mg/1 Details
Solifenacin Succinate 5 mg/1
Solifenacin Succinate is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is SOLIFENACIN SUCCINATE.
MedlinePlus Drug Summary
Solifenacin (VESIcare) is used to treat overactive bladder (a condition in which the bladder muscles contract uncontrollably and cause frequent urination, urgent need to urinate, and inability to control urination). Solifenacin (VESIcare LS) is used to treat neurogenic detrusor overactivity (a bladder control condition caused by brain, spinal cord or nerve problem) in children 2 years of age and older. Solifenacin is in a class of medications called antimuscarinics. It works by relaxing the bladder muscles.
Related Packages: 65862-0878-03Last Updated: 02/19/2023
MedLinePlus Full Drug Details: Solifenacin
Product Information
| NDC | 65862-0878 |
|---|---|
| Product ID | 65862-878_23e11677-e5e3-44a1-9de8-5e40a2c92200 |
| Associated GPIs | |
| GCN Sequence Number | 057982 |
| GCN Sequence Number Description | solifenacin succinate TABLET 5 MG ORAL |
| HIC3 | R1I |
| HIC3 Description | URINARY TRACT ANTISPASMODIC, M(3) SELECTIVE ANTAG. |
| GCN | 23276 |
| HICL Sequence Number | 026595 |
| HICL Sequence Number Description | SOLIFENACIN SUCCINATE |
| Brand/Generic | Generic |
| Proprietary Name | Solifenacin Succinate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Solifenacin Succinate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/1 |
| Substance Name | SOLIFENACIN SUCCINATE |
| Labeler Name | Aurobindo Pharma Limited |
| Pharmaceutical Class | Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA206817 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65862-0878-03 (65862087803)
| NDC Package Code | 65862-878-03 |
|---|---|
| Billing NDC | 65862087803 |
| Package | 3 BLISTER PACK in 1 CARTON (65862-878-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-878-10) |
| Marketing Start Date | 2022-12-27 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |