benztropine mesylate

Generic: benztropine mesylate

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name benztropine mesylate
Generic Name benztropine mesylate
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

benztropine mesylate 1 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-840
Product ID 63187-840_6d5cf36c-417b-4b36-b570-2a757b516246
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 63187840
Hyphenated Format 63187-840

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
  • 3 TABLET in 1 BOTTLE (63187-840-03)
  • 30 TABLET in 1 BOTTLE (63187-840-30)
  • 90 TABLET in 1 BOTTLE (63187-840-60)
  • 60 TABLET in 1 BOTTLE (63187-840-90)
source: ndc

Packages (4)

63187-840-03 3 TABLET in 1 BOTTLE (63187-840-03) 63187-840-30 30 TABLET in 1 BOTTLE (63187-840-30) 63187-840-60 90 TABLET in 1 BOTTLE (63187-840-60) 63187-840-90 60 TABLET in 1 BOTTLE (63187-840-90)

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": "6d5cf36c-417b-4b36-b570-2a757b516246", "openfda": {"unii": ["WMJ8TL7510"], "rxcui": ["885213"], "spl_set_id": ["c1044563-2bd2-4f43-a951-25d083b1c679"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "3 TABLET in 1 BOTTLE (63187-840-03)", "package_ndc": "63187-840-03", "marketing_start_date": "20170501"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (63187-840-30)", "package_ndc": "63187-840-30", "marketing_start_date": "20170501"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (63187-840-60)", "package_ndc": "63187-840-60", "marketing_start_date": "20170501"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (63187-840-90)", "package_ndc": "63187-840-90", "marketing_start_date": "20170501"}], "brand_name": "BENZTROPINE MESYLATE", "product_id": "63187-840_6d5cf36c-417b-4b36-b570-2a757b516246", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Antihistamine [EPC]", "Cholinergic Antagonists [MoA]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "63187-840", "generic_name": "BENZTROPINE MESYLATE", "labeler_name": "Proficient Rx LP", "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"}