flumazenil

Generic: flumazenil

Labeler: henry schein, inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name flumazenil
Generic Name flumazenil
Labeler henry schein, inc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

flumazenil .1 mg/mL

Manufacturer
Henry Schein, Inc

Identifiers & Regulatory

Product NDC 0404-9860
Product ID 0404-9860_7ffd4deb-5b2a-4f5a-9fae-fe764f86fcf9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076755
Marketing Start 2022-01-10
Marketing End 2026-07-31

Pharmacologic Class

Established (EPC)
benzodiazepine antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04049860
Hyphenated Format 0404-9860

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 ANDA076755 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .1 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 BAG (0404-9860-05) / 5 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

0404-9860-05 1 VIAL, MULTI-DOSE in 1 BAG (0404-9860-05) / 5 mL in 1 VIAL, MULTI-DOSE

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": "7ffd4deb-5b2a-4f5a-9fae-fe764f86fcf9", "openfda": {"nui": ["N0000175680"], "unii": ["40P7XK9392"], "rxcui": ["204508"], "spl_set_id": ["904f7154-433a-4ea1-b622-acf79568d96b"], "pharm_class_epc": ["Benzodiazepine Antagonist [EPC]"], "manufacturer_name": ["Henry Schein, Inc"]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 BAG (0404-9860-05)  / 5 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "0404-9860-05", "marketing_end_date": "20260731", "marketing_start_date": "20220110"}], "brand_name": "Flumazenil", "product_id": "0404-9860_7ffd4deb-5b2a-4f5a-9fae-fe764f86fcf9", "dosage_form": "INJECTION", "pharm_class": ["Benzodiazepine Antagonist [EPC]"], "product_ndc": "0404-9860", "generic_name": "flumazenil", "labeler_name": "Henry Schein, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Flumazenil", "active_ingredients": [{"name": "FLUMAZENIL", "strength": ".1 mg/mL"}], "application_number": "ANDA076755", "marketing_category": "ANDA", "marketing_end_date": "20260731", "marketing_start_date": "20220110"}