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NDC 42291-0053-30 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 AvKARE. 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: 42291-0053-30Last Updated: 04/07/2024
MedLinePlus Full Drug Details: Fesoterodine
Product Information
NDC | 42291-0053 |
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Product ID | 42291-053_0995fc87-8581-8c9f-e063-6294a90ad91f |
Associated GPIs | |
GCN Sequence Number | 064000 |
GCN Sequence Number Description | fesoterodine fumarate TAB ER 24H 4 MG ORAL |
HIC3 | R1A |
HIC3 Description | URINARY TRACT ANTISPASMODIC/ANTIINCONTINENCE AGENT |
GCN | 99711 |
HICL Sequence Number | 035606 |
HICL Sequence Number Description | FESOTERODINE FUMARATE |
Brand/Generic | Generic |
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 | AvKARE |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA205002 |
Listing Certified Through | 2024-12-31 |
Package
NDC 42291-0053-30 (42291005330)
NDC Package Code | 42291-053-30 |
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Billing NDC | 42291005330 |
Package | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-053-30) |
Marketing Start Date | 2023-11-07 |
NDC Exclude Flag | N |
Pricing Information | N/A |