benztropine mesylate

Generic: benztropine mesylate

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name benztropine mesylate
Generic Name benztropine mesylate
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

benztropine mesylate 1 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-970
Product ID 63323-970_11222231-55b1-48ee-a8f8-3385f1a2eb36
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090233
Listing Expiration 2026-12-31
Marketing Start 2011-05-31

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 63323970
Hyphenated Format 63323-970

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 ANDA090233 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 5 VIAL in 1 BOX (63323-970-02) / 2 mL in 1 VIAL
source: ndc

Packages (1)

63323-970-02 5 VIAL in 1 BOX (63323-970-02) / 2 mL in 1 VIAL

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": "11222231-55b1-48ee-a8f8-3385f1a2eb36", "openfda": {"unii": ["WMJ8TL7510"], "rxcui": ["885205"], "spl_set_id": ["b03bd28e-3b44-41e4-9a7e-28b9d7975245"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL in 1 BOX (63323-970-02)  / 2 mL in 1 VIAL", "package_ndc": "63323-970-02", "marketing_start_date": "20110531"}], "brand_name": "BENZTROPINE MESYLATE", "product_id": "63323-970_11222231-55b1-48ee-a8f8-3385f1a2eb36", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Antihistamine [EPC]", "Cholinergic Antagonists [MoA]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "63323-970", "generic_name": "BENZTROPINE MESYLATE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BENZTROPINE MESYLATE", "active_ingredients": [{"name": "BENZTROPINE MESYLATE", "strength": "1 mg/mL"}], "application_number": "ANDA090233", "marketing_category": "ANDA", "marketing_start_date": "20110531", "listing_expiration_date": "20261231"}