flumazenil

Generic: flumazenil

Labeler: propharma distribution
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name flumazenil
Generic Name flumazenil
Labeler propharma distribution
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

flumazenil .1 mg/mL

Manufacturer
ProPharma Distribution

Identifiers & Regulatory

Product NDC 84549-783
Product ID 84549-783_3f7a30b5-2727-0c82-e063-6394a90a92dd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078527
Listing Expiration 2026-12-31
Marketing Start 2007-01-01

Pharmacologic Class

Established (EPC)
benzodiazepine antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 84549783
Hyphenated Format 84549-783

Supplemental Identifiers

RxCUI
204508
UNII
40P7XK9392
NUI
N0000175680

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 flumazenil (source: ndc)
Generic Name flumazenil (source: ndc)
Application Number ANDA078527 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .1 mg/mL
source: ndc
Packaging
  • 10 mL in 1 VIAL, MULTI-DOSE (84549-783-10)
source: ndc

Packages (1)

84549-783-10 10 mL in 1 VIAL, MULTI-DOSE (84549-783-10)

Ingredients (1)

flumazenil (.1 mg/mL)

Linked Drug Pages (1)

Flumazenil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "3f7a30b5-2727-0c82-e063-6394a90a92dd", "openfda": {"nui": ["N0000175680"], "unii": ["40P7XK9392"], "rxcui": ["204508"], "spl_set_id": ["3f7a30b5-2728-0c82-e063-6394a90a92dd"], "pharm_class_epc": ["Benzodiazepine Antagonist [EPC]"], "manufacturer_name": ["ProPharma Distribution"]}, "finished": true, "packaging": [{"sample": false, "description": "10 mL in 1 VIAL, MULTI-DOSE (84549-783-10)", "package_ndc": "84549-783-10", "marketing_start_date": "20250923"}], "brand_name": "Flumazenil", "product_id": "84549-783_3f7a30b5-2727-0c82-e063-6394a90a92dd", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Benzodiazepine Antagonist [EPC]"], "product_ndc": "84549-783", "generic_name": "flumazenil", "labeler_name": "ProPharma Distribution", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Flumazenil", "active_ingredients": [{"name": "FLUMAZENIL", "strength": ".1 mg/mL"}], "application_number": "ANDA078527", "marketing_category": "ANDA", "marketing_start_date": "20070101", "listing_expiration_date": "20261231"}