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NDC 65162-0369-03 Fesoterodine Fumarate 4 mg/1 Details
Fesoterodine Fumarate 4 mg/1
Fesoterodine Fumarate is a ORAL TABLET, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals LLC. The primary component is FESOTERODINE FUMARATE.
MedlinePlus Drug Summary
Fesoterodine 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). Fesoterodine is in a class of medications called antimuscarinics. It works by relaxing the bladder muscles to prevent urgent, frequent, or uncontrolled urination.
Related Packages: 65162-0369-03Last Updated: 02/19/2023
MedLinePlus Full Drug Details: Fesoterodine
Product Information
| NDC | 65162-0369 |
|---|---|
| Product ID | 65162-369_9da83697-4ecd-4da8-804a-d0c229ec3d20 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Fesoterodine Fumarate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Fesoterodine Fumarate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 4 |
| Active Ingredient Units | mg/1 |
| Substance Name | FESOTERODINE FUMARATE |
| Labeler Name | Amneal Pharmaceuticals LLC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA205002 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65162-0369-03 (65162036903)
| NDC Package Code | 65162-369-03 |
|---|---|
| Billing NDC | 65162036903 |
| Package | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-369-03) |
| Marketing Start Date | 2023-01-06 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |