flumazenil

Generic: flumazenil

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name flumazenil
Generic Name flumazenil
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

flumazenil .1 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9684
Product ID 0143-9684_0ecaa504-add6-48df-817f-e5d5eef9fc8b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078527
Listing Expiration 2026-12-31
Marketing Start 2009-03-23

Pharmacologic Class

Established (EPC)
benzodiazepine antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439684
Hyphenated Format 0143-9684

Supplemental Identifiers

RxCUI
204508
UPC
0301439683100 0301439684107
UNII
40P7XK9392
NUI
N0000175680

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 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 VIAL, MULTI-DOSE in 1 BOX (0143-9684-10) / 5 mL in 1 VIAL, MULTI-DOSE (0143-9684-01)
source: ndc

Packages (1)

0143-9684-10 10 VIAL, MULTI-DOSE in 1 BOX (0143-9684-10) / 5 mL in 1 VIAL, MULTI-DOSE (0143-9684-01)

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": "0ecaa504-add6-48df-817f-e5d5eef9fc8b", "openfda": {"nui": ["N0000175680"], "upc": ["0301439683100", "0301439684107"], "unii": ["40P7XK9392"], "rxcui": ["204508"], "spl_set_id": ["436f5616-9626-4b6a-9deb-2986444179d0"], "pharm_class_epc": ["Benzodiazepine Antagonist [EPC]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, MULTI-DOSE in 1 BOX (0143-9684-10)  / 5 mL in 1 VIAL, MULTI-DOSE (0143-9684-01)", "package_ndc": "0143-9684-10", "marketing_start_date": "20090323"}], "brand_name": "Flumazenil", "product_id": "0143-9684_0ecaa504-add6-48df-817f-e5d5eef9fc8b", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Benzodiazepine Antagonist [EPC]"], "product_ndc": "0143-9684", "generic_name": "Flumazenil", "labeler_name": "Hikma Pharmaceuticals USA 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": "20090323", "listing_expiration_date": "20261231"}