flumazenil

Generic: flumazenil

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name flumazenil
Generic Name flumazenil
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

flumazenil .1 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-424
Product ID 63323-424_9f9520ae-2135-4731-8fb2-8a0a771c302b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076955
Listing Expiration 2026-12-31
Marketing Start 2005-04-05

Pharmacologic Class

Established (EPC)
benzodiazepine antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323424
Hyphenated Format 63323-424

Supplemental Identifiers

RxCUI
204508
UPC
0363323424015 0363323424107
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 ANDA076955 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .1 mg/mL
source: ndc
Packaging
  • 10 VIAL, MULTI-DOSE in 1 TRAY (63323-424-05) / 5 mL in 1 VIAL, MULTI-DOSE (63323-424-01)
  • 1 VIAL, MULTI-DOSE in 1 CARTON (63323-424-10) / 10 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (2)

63323-424-05 10 VIAL, MULTI-DOSE in 1 TRAY (63323-424-05) / 5 mL in 1 VIAL, MULTI-DOSE (63323-424-01) 63323-424-10 1 VIAL, MULTI-DOSE in 1 CARTON (63323-424-10) / 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": "9f9520ae-2135-4731-8fb2-8a0a771c302b", "openfda": {"nui": ["N0000175680"], "upc": ["0363323424015", "0363323424107"], "unii": ["40P7XK9392"], "rxcui": ["204508"], "spl_set_id": ["a72d9fc1-121c-455d-93a9-002378c9968f"], "pharm_class_epc": ["Benzodiazepine Antagonist [EPC]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, MULTI-DOSE in 1 TRAY (63323-424-05)  / 5 mL in 1 VIAL, MULTI-DOSE (63323-424-01)", "package_ndc": "63323-424-05", "marketing_start_date": "20050405"}, {"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (63323-424-10)  / 10 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "63323-424-10", "marketing_start_date": "20050405"}], "brand_name": "Flumazenil", "product_id": "63323-424_9f9520ae-2135-4731-8fb2-8a0a771c302b", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Benzodiazepine Antagonist [EPC]"], "product_ndc": "63323-424", "generic_name": "FLUMAZENIL", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Flumazenil", "active_ingredients": [{"name": "FLUMAZENIL", "strength": ".1 mg/mL"}], "application_number": "ANDA076955", "marketing_category": "ANDA", "marketing_start_date": "20050405", "listing_expiration_date": "20261231"}