benztropine mesylate

Generic: benztropine mesylate

Labeler: navinta llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name benztropine mesylate
Generic Name benztropine mesylate
Labeler navinta llc
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

benztropine mesylate 1 mg/mL

Manufacturer
Navinta LLC

Identifiers & Regulatory

Product NDC 68475-512
Product ID 68475-512_521bb578-ab37-48e7-a65d-3afe458872b5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091525
Listing Expiration 2026-12-31
Marketing Start 2020-11-24

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 68475512
Hyphenated Format 68475-512

Supplemental Identifiers

RxCUI
885205
UPC
0368475512023 0368475512016
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 (68475-512-02) / 2 mL in 1 VIAL (68475-512-01)
source: ndc

Packages (1)

68475-512-02 5 VIAL in 1 CARTON (68475-512-02) / 2 mL in 1 VIAL (68475-512-01)

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": "521bb578-ab37-48e7-a65d-3afe458872b5", "openfda": {"upc": ["0368475512023", "0368475512016"], "unii": ["WMJ8TL7510"], "rxcui": ["885205"], "spl_set_id": ["f92fbafa-314d-4449-831f-26108339e6b2"], "manufacturer_name": ["Navinta LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL in 1 CARTON (68475-512-02)  / 2 mL in 1 VIAL (68475-512-01)", "package_ndc": "68475-512-02", "marketing_start_date": "20201124"}], "brand_name": "Benztropine Mesylate", "product_id": "68475-512_521bb578-ab37-48e7-a65d-3afe458872b5", "dosage_form": "INJECTION", "pharm_class": ["Anticholinergic [EPC]", "Antihistamine [EPC]", "Cholinergic Antagonists [MoA]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "68475-512", "generic_name": "Benztropine Mesylate", "labeler_name": "Navinta LLC", "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": "20201124", "listing_expiration_date": "20261231"}