FDA.reportPublic FDA data

Flumazenil

Product NDC
0143-9784
11-digit product format
001439784
Labeler code
0143
Product ID
0143-9784_61456aa8-ed8f-4c3c-be90-9bf4b2d46025
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
flumazenil
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA078527
Marketing category
ANDA
Marketing start
2007-01-01
Substance
FLUMAZENIL
Active strength
.1 mg/mL
Pharmacologic classes
Benzodiazepine Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Flumazenil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUMAZENIL.1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii40P7XK9392
Rxcui204508

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9784-01Flumazenil5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION59
0143-9784-10Flumazenil10 in 1 BOXINJECTION, SOLUTION109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9784-01ML - Milliliter0143-9784c9853605-07c6-41ee-a025-9112f9b0da4e12016-05-16
0143-9784-10ML - Milliliter0143-9784cf4eda99-4c89-482c-9550-cf6650215ddd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUMAZENILACTIVE INGREDIENT40P7XK9392FLUMAZENIL INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4
FLUMAZENILACTIVE MOIETY40P7XK9392FLUMAZENIL INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PFLUMAZENIL INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KFLUMAZENIL INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBFLUMAZENIL INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TFLUMAZENIL INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHFLUMAZENIL INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XFLUMAZENIL INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IFLUMAZENIL INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9784FLUMAZENIL INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]9Current NDC, Legacy NDC, 2 package rows20240410_442ed32b-b508-40cc-9915-ff05674566da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204508flumazenil 0.1 MG/ML Injectable SolutionPSN2190e8d0-d7ca-4f53-b243-0d2c31979aa825
204508flumazenil 0.1 MG/ML Injectable SolutionSCD2190e8d0-d7ca-4f53-b243-0d2c31979aa825
204508flumazenil 0.1 MG/ML Injectable SolutionPSN442ed32b-b508-40cc-9915-ff05674566da9
204508flumazenil 0.1 MG/ML Injectable SolutionSCD442ed32b-b508-40cc-9915-ff05674566da9
204508flumazenil 0.1 MG/ML Injectable SolutionPSN74d007e9-9604-0941-e053-2a91aa0a29c48
204508flumazenil 0.1 MG/ML Injectable SolutionSCD74d007e9-9604-0941-e053-2a91aa0a29c48
204508flumazenil 0.1 MG/ML Injectable SolutionPSN6673efde-057a-a889-e053-2a91aa0a517b3
204508flumazenil 0.1 MG/ML Injectable SolutionSCD6673efde-057a-a889-e053-2a91aa0a517b3
204508flumazenil 0.1 MG/ML Injectable SolutionPSN3eefb01b-3d6a-a3eb-e063-6394a90a48292
204508flumazenil 0.1 MG/ML Injectable SolutionSCD3eefb01b-3d6a-a3eb-e063-6394a90a48292
204508flumazenil 0.1 MG/ML Injectable SolutionPSN1855bb03-392f-4a0d-8361-24fc2a0e635e1
204508flumazenil 0.1 MG/ML Injectable SolutionPSN4cc7f2af-1eba-3d01-e054-00144ff88e881
204508flumazenil 0.1 MG/ML Injectable SolutionPSN8117cab2-65ff-326b-e053-2991aa0abb9c1
204508flumazenil 0.1 MG/ML Injectable SolutionSCD1855bb03-392f-4a0d-8361-24fc2a0e635e1
204508flumazenil 0.1 MG/ML Injectable SolutionSCD4cc7f2af-1eba-3d01-e054-00144ff88e881
204508flumazenil 0.1 MG/ML Injectable SolutionSCD8117cab2-65ff-326b-e053-2991aa0abb9c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9784-01001439784015 mL in 1 VIAL, MULTI-DOSE5 mlHistorical
0143-9784-100014397841010 VIAL, MULTI-DOSE in 1 BOX (0143-9784-10) / 5 mL in 1 VIAL, MULTI-DOSE (0143-9784-01) 2007-01-010000-00-00NoNoCurrent