benztropine mesylate

Generic: benztropine mesylate

Labeler: quagen pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

benztropine mesylate .5 mg/1

Manufacturer
QUAGEN PHARMACEUTICALS LLC

Identifiers & Regulatory

Product NDC 70752-123
Product ID 70752-123_073409b4-0ae6-43d5-804a-a15ca581ecd9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212694
Listing Expiration 2026-12-31
Marketing Start 2025-08-11

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 70752123
Hyphenated Format 70752-123

Supplemental Identifiers

RxCUI
885209 885213 885219
UNII
WMJ8TL7510

Packaging Origin

Original Packager
true

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 ANDA212694 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (70752-123-10)
  • 1000 TABLET in 1 BOTTLE, PLASTIC (70752-123-11)
source: ndc

Packages (2)

Ingredients (1)

benztropine mesylate (.5 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "073409b4-0ae6-43d5-804a-a15ca581ecd9", "openfda": {"unii": ["WMJ8TL7510"], "rxcui": ["885209", "885213", "885219"], "spl_set_id": ["e1f0a249-e660-4592-9ffc-1c02b1022778"], "manufacturer_name": ["QUAGEN PHARMACEUTICALS LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (70752-123-10)", "package_ndc": "70752-123-10", "marketing_start_date": "20250811"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (70752-123-11)", "package_ndc": "70752-123-11", "marketing_start_date": "20250811"}], "brand_name": "BENZTROPINE MESYLATE", "product_id": "70752-123_073409b4-0ae6-43d5-804a-a15ca581ecd9", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Antihistamine [EPC]", "Cholinergic Antagonists [MoA]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "70752-123", "generic_name": "BENZTROPINE MESYLATE", "labeler_name": "QUAGEN PHARMACEUTICALS LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BENZTROPINE MESYLATE", "active_ingredients": [{"name": "BENZTROPINE MESYLATE", "strength": ".5 mg/1"}], "application_number": "ANDA212694", "marketing_category": "ANDA", "marketing_start_date": "20250811", "listing_expiration_date": "20261231"}