benztropine mesylate

Generic: benztropine mesylate

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name benztropine mesylate
Generic Name benztropine mesylate
Labeler major pharmaceuticals
Dosage Form TABLET
Routes
ORAL
Active Ingredients

benztropine mesylate .5 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7288
Product ID 0904-7288_84795729-e08a-4fd6-97e9-0c07f691d162
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040715
Listing Expiration 2026-12-31
Marketing Start 2023-07-11

Pharmacologic Class

Classes
anticholinergic [epc] antihistamine [epc] cholinergic antagonists [moa] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047288
Hyphenated Format 0904-7288

Supplemental Identifiers

RxCUI
885209 885213 885219
UNII
WMJ8TL7510

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name benztropine mesylate (source: ndc)
Generic Name benztropine mesylate (source: ndc)
Application Number ANDA040715 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-7288-61) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7288-61 100 BLISTER PACK in 1 CARTON (0904-7288-61) / 1 TABLET in 1 BLISTER PACK

Ingredients (1)

benztropine mesylate (.5 mg/1)

Linked Drug Pages (1)

Benztropine Mesylate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "84795729-e08a-4fd6-97e9-0c07f691d162", "openfda": {"unii": ["WMJ8TL7510"], "rxcui": ["885209", "885213", "885219"], "spl_set_id": ["8b18b66c-2935-4304-8e20-ebf68dee5a1a"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-7288-61)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "0904-7288-61", "marketing_start_date": "20230711"}], "brand_name": "Benztropine Mesylate", "product_id": "0904-7288_84795729-e08a-4fd6-97e9-0c07f691d162", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Antihistamine [EPC]", "Cholinergic Antagonists [MoA]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "0904-7288", "generic_name": "benztropine mesylate", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Benztropine Mesylate", "active_ingredients": [{"name": "BENZTROPINE MESYLATE", "strength": ".5 mg/1"}], "application_number": "ANDA040715", "marketing_category": "ANDA", "marketing_start_date": "20230711", "listing_expiration_date": "20261231"}