benztropine mesylate

Generic: benztropine mesylate

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name benztropine mesylate
Generic Name benztropine mesylate
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

benztropine mesylate 1 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9233
Product ID 0143-9233_a86273c1-08ac-4b57-a796-24989c8a2842
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209442
Listing Expiration 2026-12-31
Marketing Start 2021-10-14

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 01439233
Hyphenated Format 0143-9233

Supplemental Identifiers

RxCUI
885205
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 ANDA209442 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 5 VIAL in 1 BOX (0143-9233-05) / 2 mL in 1 VIAL (0143-9233-01)
source: ndc

Packages (1)

0143-9233-05 5 VIAL in 1 BOX (0143-9233-05) / 2 mL in 1 VIAL (0143-9233-01)

Ingredients (1)

benztropine mesylate (1 mg/mL)

Linked Drug Pages (1)

Benztropine Mesylate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "a86273c1-08ac-4b57-a796-24989c8a2842", "openfda": {"unii": ["WMJ8TL7510"], "rxcui": ["885205"], "spl_set_id": ["accd7e33-ca6e-46e6-a2ae-20b9bcd8fb89"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL in 1 BOX (0143-9233-05)  / 2 mL in 1 VIAL (0143-9233-01)", "package_ndc": "0143-9233-05", "marketing_start_date": "20211014"}], "brand_name": "Benztropine Mesylate", "product_id": "0143-9233_a86273c1-08ac-4b57-a796-24989c8a2842", "dosage_form": "INJECTION", "pharm_class": ["Anticholinergic [EPC]", "Antihistamine [EPC]", "Cholinergic Antagonists [MoA]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "0143-9233", "generic_name": "Benztropine Mesylate", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Benztropine Mesylate", "active_ingredients": [{"name": "BENZTROPINE MESYLATE", "strength": "1 mg/mL"}], "application_number": "ANDA209442", "marketing_category": "ANDA", "marketing_start_date": "20211014", "listing_expiration_date": "20261231"}