benztropine mesylate

Generic: benztropine mesylate

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

Drug Facts

Product Profile

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

benztropine mesylate 1 mg/mL

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-860
Product ID 68382-860_c4849b63-a84f-4cf0-b937-7ca4b33f2d25
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091525
Listing Expiration 2026-12-31
Marketing Start 2020-12-30

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 68382860
Hyphenated Format 68382-860

Supplemental Identifiers

RxCUI
885205
UPC
0368382860101 0368382860026
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 ANDA091525 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 5 VIAL in 1 CARTON (68382-860-10) / 2 mL in 1 VIAL (68382-860-02)
source: ndc

Packages (1)

68382-860-10 5 VIAL in 1 CARTON (68382-860-10) / 2 mL in 1 VIAL (68382-860-02)

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": "c4849b63-a84f-4cf0-b937-7ca4b33f2d25", "openfda": {"upc": ["0368382860101", "0368382860026"], "unii": ["WMJ8TL7510"], "rxcui": ["885205"], "spl_set_id": ["ecaeaadf-0847-4605-a205-a674f75f8bb2"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL in 1 CARTON (68382-860-10)  / 2 mL in 1 VIAL (68382-860-02)", "package_ndc": "68382-860-10", "marketing_start_date": "20201230"}], "brand_name": "Benztropine Mesylate", "product_id": "68382-860_c4849b63-a84f-4cf0-b937-7ca4b33f2d25", "dosage_form": "INJECTION", "pharm_class": ["Anticholinergic [EPC]", "Antihistamine [EPC]", "Cholinergic Antagonists [MoA]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "68382-860", "generic_name": "Benztropine Mesylate", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Benztropine Mesylate", "active_ingredients": [{"name": "BENZTROPINE MESYLATE", "strength": "1 mg/mL"}], "application_number": "ANDA091525", "marketing_category": "ANDA", "marketing_start_date": "20201230", "listing_expiration_date": "20261231"}