benztropine mesylate

Generic: benztropine mesylate

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name benztropine mesylate
Generic Name benztropine mesylate
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form TABLET
Routes
ORAL
Active Ingredients

benztropine mesylate 2 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8478
Product ID 0615-8478_a5d295e0-1f2a-41a0-bff9-64b027f7bcde
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040715
Listing Expiration 2027-12-31
Marketing Start 2022-03-17

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 06158478
Hyphenated Format 0615-8478

Supplemental Identifiers

RxCUI
885209
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
  • 30 TABLET in 1 BLISTER PACK (0615-8478-39)
source: ndc

Packages (1)

0615-8478-39 30 TABLET in 1 BLISTER PACK (0615-8478-39)

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": "a5d295e0-1f2a-41a0-bff9-64b027f7bcde", "openfda": {"unii": ["WMJ8TL7510"], "rxcui": ["885209"], "spl_set_id": ["bac9dfb7-aa09-4841-9e8f-cc41bb438fe2"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (0615-8478-39)", "package_ndc": "0615-8478-39", "marketing_start_date": "20230428"}], "brand_name": "Benztropine Mesylate", "product_id": "0615-8478_a5d295e0-1f2a-41a0-bff9-64b027f7bcde", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Antihistamine [EPC]", "Cholinergic Antagonists [MoA]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "0615-8478", "generic_name": "benztropine mesylate", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "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": "20220317", "listing_expiration_date": "20271231"}