flumazenil

Generic: flumazenil

Labeler: hf acquisition co. llc, dba health first
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name flumazenil
Generic Name flumazenil
Labeler hf acquisition co. llc, dba health first
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

flumazenil .1 mg/mL

Manufacturer
HF Acquisition Co. LLC, DBA Health First

Identifiers & Regulatory

Product NDC 51662-1253
Product ID 51662-1253_101e7ca0-b5a1-f122-e063-6394a90a6649
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078527
Listing Expiration 2026-12-31
Marketing Start 2018-08-26

Pharmacologic Class

Established (EPC)
benzodiazepine antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516621253
Hyphenated Format 51662-1253

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 (51662-1253-1)
  • 10 POUCH in 1 CASE (51662-1253-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1253-2) / 10 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (2)

51662-1253-1 10 mL in 1 VIAL, MULTI-DOSE (51662-1253-1) 51662-1253-3 10 POUCH in 1 CASE (51662-1253-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1253-2) / 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": "101e7ca0-b5a1-f122-e063-6394a90a6649", "openfda": {"nui": ["N0000175680"], "unii": ["40P7XK9392"], "rxcui": ["204508"], "spl_set_id": ["744ef484-ef46-8d62-e053-2a91aa0a0c05"], "pharm_class_epc": ["Benzodiazepine Antagonist [EPC]"], "manufacturer_name": ["HF Acquisition Co. LLC, DBA Health First"]}, "finished": true, "packaging": [{"sample": false, "description": "10 mL in 1 VIAL, MULTI-DOSE (51662-1253-1)", "package_ndc": "51662-1253-1", "marketing_start_date": "20180826"}, {"sample": false, "description": "10 POUCH in 1 CASE (51662-1253-3)  / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1253-2)  / 10 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "51662-1253-3", "marketing_start_date": "20221110"}], "brand_name": "FLUMAZENIL", "product_id": "51662-1253_101e7ca0-b5a1-f122-e063-6394a90a6649", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Benzodiazepine Antagonist [EPC]"], "product_ndc": "51662-1253", "generic_name": "FLUMAZENIL", "labeler_name": "HF Acquisition Co. LLC, DBA Health First", "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": "20180826", "listing_expiration_date": "20261231"}