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, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

flumazenil .1 mg/mL

Manufacturer
Henry Schein, Inc.

Identifiers & Regulatory

Product NDC 0404-9794
Product ID 0404-9794_cc861fb6-616a-4f44-8713-f1951a73fd5b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078527
Listing Expiration 2026-12-31
Marketing Start 2025-02-14

Pharmacologic Class

Established (EPC)
benzodiazepine antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04049794
Hyphenated Format 0404-9794

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
  • 1 VIAL, MULTI-DOSE in 1 BAG (0404-9794-10) / 10 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

0404-9794-10 1 VIAL, MULTI-DOSE in 1 BAG (0404-9794-10) / 10 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": "cc861fb6-616a-4f44-8713-f1951a73fd5b", "openfda": {"nui": ["N0000175680"], "unii": ["40P7XK9392"], "rxcui": ["204508"], "spl_set_id": ["3ea41cbe-bc07-4c95-8bb2-7dfc2e96a874"], "pharm_class_epc": ["Benzodiazepine Antagonist [EPC]"], "manufacturer_name": ["Henry Schein, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 BAG (0404-9794-10)  / 10 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "0404-9794-10", "marketing_start_date": "20250214"}], "brand_name": "FLUMAZENIL", "product_id": "0404-9794_cc861fb6-616a-4f44-8713-f1951a73fd5b", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Benzodiazepine Antagonist [EPC]"], "product_ndc": "0404-9794", "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": "ANDA078527", "marketing_category": "ANDA", "marketing_start_date": "20250214", "listing_expiration_date": "20261231"}