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NDC 62332-0176-91 Fesoterodine Fumarate 8 mg/1 Details
Fesoterodine Fumarate 8 mg/1
Fesoterodine Fumarate is a ORAL TABLET, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Alembic Pharmaceuticals Inc.. The primary component is FESOTERODINE FUMARATE.
Product Information
| NDC | 62332-0176 |
|---|---|
| Product ID | 62332-176_d347263f-9458-4986-be65-e626f490bb3b |
| Associated GPIs | |
| GCN Sequence Number | 064001 |
| GCN Sequence Number Description | fesoterodine fumarate TAB ER 24H 8 MG ORAL |
| HIC3 | R1A |
| HIC3 Description | URINARY TRACT ANTISPASMODIC/ANTIINCONTINENCE AGENT |
| GCN | 99712 |
| 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 | 8 |
| Active Ingredient Units | mg/1 |
| Substance Name | FESOTERODINE FUMARATE |
| Labeler Name | Alembic Pharmaceuticals Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA204973 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 62332-0176-91 (62332017691)
| NDC Package Code | 62332-176-91 |
|---|---|
| Billing NDC | 62332017691 |
| Package | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-176-91) |
| Marketing Start Date | 2023-01-06 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |