benztropine mesylate

Generic: benztropine mesylate

Labeler: marlex pharmaceutical, inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name benztropine mesylate
Generic Name benztropine mesylate
Labeler marlex pharmaceutical, inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

benztropine mesylate .5 mg/1

Manufacturer
Marlex PHARMACEUTICAL, INC

Identifiers & Regulatory

Product NDC 10135-813
Product ID 10135-813_31bbcbfa-dc75-99e2-e063-6394a90aa608
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204713
Listing Expiration 2026-12-31
Marketing Start 2025-03-01

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 10135813
Hyphenated Format 10135-813

Supplemental Identifiers

RxCUI
885209 885213 885219
UPC
0310135815104 0310135813100
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 ANDA204713 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (10135-813-01)
  • 1000 TABLET in 1 BOTTLE (10135-813-10)
source: ndc

Packages (2)

10135-813-01 100 TABLET in 1 BOTTLE (10135-813-01) 10135-813-10 1000 TABLET in 1 BOTTLE (10135-813-10)

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": "31bbcbfa-dc75-99e2-e063-6394a90aa608", "openfda": {"upc": ["0310135815104", "0310135813100"], "unii": ["WMJ8TL7510"], "rxcui": ["885209", "885213", "885219"], "spl_set_id": ["31bbcbfa-dc74-99e2-e063-6394a90aa608"], "manufacturer_name": ["Marlex PHARMACEUTICAL, INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (10135-813-01)", "package_ndc": "10135-813-01", "marketing_start_date": "20250301"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (10135-813-10)", "package_ndc": "10135-813-10", "marketing_start_date": "20250301"}], "brand_name": "BENZTROPINE MESYLATE", "product_id": "10135-813_31bbcbfa-dc75-99e2-e063-6394a90aa608", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Antihistamine [EPC]", "Cholinergic Antagonists [MoA]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "10135-813", "generic_name": "benztropine mesylate", "labeler_name": "Marlex PHARMACEUTICAL, INC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BENZTROPINE MESYLATE", "active_ingredients": [{"name": "BENZTROPINE MESYLATE", "strength": ".5 mg/1"}], "application_number": "ANDA204713", "marketing_category": "ANDA", "marketing_start_date": "20250301", "listing_expiration_date": "20261231"}