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NDC 43353-0580-53 Benztropine Mesylate 1 mg/1 Details
Benztropine Mesylate 1 mg/1
Benztropine Mesylate is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aphena Pharma Solutions - Tennnessee, LLC. The primary component is BENZTROPINE MESYLATE.
MedlinePlus Drug Summary
Benztropine is used along with other medications to treat the symptoms of Parkinson's disease (PD; a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) and tremors caused by other medical problems or medications. Benztropine is in a class of medications called anticholinergics. It works by blocking a certain natural substance (acetylcholine) to help to decrease symptoms in people with Parkinson's disease.
Related Packages: 43353-0580-53Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Benztropine
Product Information
| NDC | 43353-0580 |
|---|---|
| Product ID | 43353-580_492e8cdc-125f-46b9-b95d-3c05ab07fe87 |
| Associated GPIs | 73100010100310 |
| GCN Sequence Number | 004590 |
| GCN Sequence Number Description | benztropine mesylate TABLET 1 MG ORAL |
| HIC3 | H6B |
| HIC3 Description | ANTIPARKINSONISM DRUGS,ANTICHOLINERGIC |
| GCN | 17621 |
| HICL Sequence Number | 001905 |
| HICL Sequence Number Description | BENZTROPINE MESYLATE |
| Brand/Generic | Generic |
| Proprietary Name | Benztropine Mesylate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | benztropine mesylate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 1 |
| Active Ingredient Units | mg/1 |
| Substance Name | BENZTROPINE MESYLATE |
| Labeler Name | Aphena Pharma Solutions - Tennnessee, LLC |
| Pharmaceutical Class | Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA204713 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 43353-0580-53 (43353058053)
| NDC Package Code | 43353-580-53 |
|---|---|
| Billing NDC | 43353058053 |
| Package | 60 TABLET in 1 BOTTLE, PLASTIC (43353-580-53) |
| Marketing Start Date | 2017-07-25 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |