benztropine mesylate

Generic: benztropine mesylate

Labeler: leading pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name benztropine mesylate
Generic Name benztropine mesylate
Labeler leading pharma, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

benztropine mesylate .5 mg/1

Manufacturer
Leading Pharma, LLC

Identifiers & Regulatory

Product NDC 69315-136
Product ID 69315-136_f61e0118-7898-42cf-9e27-e5f2dabe6ea4
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 69315136
Hyphenated Format 69315-136

Supplemental Identifiers

RxCUI
885209 885213 885219
UPC
0369315137109 0369315137017 0369315138014 0369315136102 0369315138106 0369315136010
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 ANDA090168 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (69315-136-01)
  • 1000 TABLET in 1 BOTTLE (69315-136-10)
source: ndc

Packages (2)

69315-136-01 100 TABLET in 1 BOTTLE (69315-136-01) 69315-136-10 1000 TABLET in 1 BOTTLE (69315-136-10)

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": "f61e0118-7898-42cf-9e27-e5f2dabe6ea4", "openfda": {"upc": ["0369315137109", "0369315137017", "0369315138014", "0369315136102", "0369315138106", "0369315136010"], "unii": ["WMJ8TL7510"], "rxcui": ["885209", "885213", "885219"], "spl_set_id": ["fe002ec4-07cb-41ca-a58c-33b3a8682101"], "manufacturer_name": ["Leading Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (69315-136-01)", "package_ndc": "69315-136-01", "marketing_start_date": "20160515"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (69315-136-10)", "package_ndc": "69315-136-10", "marketing_start_date": "20160515"}], "brand_name": "BENZTROPINE MESYLATE", "product_id": "69315-136_f61e0118-7898-42cf-9e27-e5f2dabe6ea4", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Antihistamine [EPC]", "Cholinergic Antagonists [MoA]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "69315-136", "generic_name": "BENZTROPINE MESYLATE", "labeler_name": "Leading Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BENZTROPINE MESYLATE", "active_ingredients": [{"name": "BENZTROPINE MESYLATE", "strength": ".5 mg/1"}], "application_number": "ANDA090168", "marketing_category": "ANDA", "marketing_start_date": "20121128", "listing_expiration_date": "20261231"}