benztropine mesylate

Generic: benztropine mesylate

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name benztropine mesylate
Generic Name benztropine mesylate
Labeler american health packaging
Dosage Form TABLET
Routes
ORAL
Active Ingredients

benztropine mesylate 2 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 68084-389
Product ID 68084-389_43e32855-d7c9-07e1-e063-6294a90af347
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040715
Listing Expiration 2026-12-31
Marketing Start 2013-07-01

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 68084389
Hyphenated Format 68084-389

Supplemental Identifiers

RxCUI
885209 885213 885219
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 ANDA040715 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-389-01) / 1 TABLET in 1 BLISTER PACK (68084-389-11)
source: ndc

Packages (1)

68084-389-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-389-01) / 1 TABLET in 1 BLISTER PACK (68084-389-11)

Ingredients (1)

benztropine mesylate (2 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": "43e32855-d7c9-07e1-e063-6294a90af347", "openfda": {"unii": ["WMJ8TL7510"], "rxcui": ["885209", "885213", "885219"], "spl_set_id": ["b7f915a9-cd53-4a74-8ee5-35ee5c5c991e"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-389-01)  / 1 TABLET in 1 BLISTER PACK (68084-389-11)", "package_ndc": "68084-389-01", "marketing_start_date": "20130701"}], "brand_name": "Benztropine Mesylate", "product_id": "68084-389_43e32855-d7c9-07e1-e063-6294a90af347", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Antihistamine [EPC]", "Cholinergic Antagonists [MoA]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "68084-389", "generic_name": "Benztropine Mesylate", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Benztropine Mesylate", "active_ingredients": [{"name": "BENZTROPINE MESYLATE", "strength": "2 mg/1"}], "application_number": "ANDA040715", "marketing_category": "ANDA", "marketing_start_date": "20130701", "listing_expiration_date": "20261231"}