benztropine mesylate

Generic: benztropine mesylate

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name benztropine mesylate
Generic Name benztropine mesylate
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

benztropine mesylate 1 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-502
Product ID 71610-502_83880a96-336b-4e03-ac29-a41e62d78f3c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090168
Listing Expiration 2026-12-31
Marketing Start 2012-11-28

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 71610502
Hyphenated Format 71610-502

Supplemental Identifiers

RxCUI
885213
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 ANDA090168 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (71610-502-53)
source: ndc

Packages (1)

71610-502-53 60 TABLET in 1 BOTTLE (71610-502-53)

Ingredients (1)

benztropine mesylate (1 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": "83880a96-336b-4e03-ac29-a41e62d78f3c", "openfda": {"unii": ["WMJ8TL7510"], "rxcui": ["885213"], "spl_set_id": ["f82c6455-f36b-49d7-881e-6601d513d846"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (71610-502-53)", "package_ndc": "71610-502-53", "marketing_start_date": "20201208"}], "brand_name": "BENZTROPINE MESYLATE", "product_id": "71610-502_83880a96-336b-4e03-ac29-a41e62d78f3c", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Antihistamine [EPC]", "Cholinergic Antagonists [MoA]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "71610-502", "generic_name": "BENZTROPINE MESYLATE", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BENZTROPINE MESYLATE", "active_ingredients": [{"name": "BENZTROPINE MESYLATE", "strength": "1 mg/1"}], "application_number": "ANDA090168", "marketing_category": "ANDA", "marketing_start_date": "20121128", "listing_expiration_date": "20261231"}