FLUMAZENIL

Product NDC
0404-9793
11-digit product format
004049793
Labeler code
0404
Product ID
0404-9793_bd300433-4b66-48b5-bd42-4b311b701907
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
flumazenil
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Henry Schein, Inc.
Application
ANDA078527
Marketing category
ANDA
Marketing start
2025-02-14
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078527-001FLUMAZENILFLUMAZENIL0.5MG/5ML (0.1MG/ML)INJECTABLE / INJECTIONAP2009-03-23
A078527-002FLUMAZENILFLUMAZENIL1MG/10ML (0.1MG/ML)INJECTABLE / INJECTIONAPRS2009-03-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A078527-001AP
A078527-002AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078527-001FLUMAZENIL0.5MG/5ML (0.1MG/ML)INJECTABLE / INJECTIONAP2009-03-23caaa826d4ba7…
2026-08-18 06:07:402026-07A078527-002FLUMAZENIL1MG/10ML (0.1MG/ML)INJECTABLE / INJECTIONAPRS2009-03-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078527-001FLUMAZENIL0.5MG/5ML (0.1MG/ML)INJECTABLE / INJECTIONAP2009-03-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078527-002FLUMAZENIL1MG/10ML (0.1MG/ML)INJECTABLE / INJECTIONAPRS2009-03-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078527-001FLUMAZENIL0.5MG/5ML (0.1MG/ML)INJECTABLE / INJECTIONAP2009-03-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078527-002FLUMAZENIL1MG/10ML (0.1MG/ML)INJECTABLE / INJECTIONAPRS2009-03-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A078527-001FLUMAZENIL0.5MG/5ML (0.1MG/ML)INJECTABLE / INJECTIONAP2009-03-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078527-002FLUMAZENIL1MG/10ML (0.1MG/ML)INJECTABLE / INJECTIONAPRS2009-03-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078527-001FLUMAZENIL0.5MG/5ML (0.1MG/ML)INJECTABLE / INJECTIONAP2009-03-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078527-002FLUMAZENIL1MG/10ML (0.1MG/ML)INJECTABLE / INJECTIONAPRS2009-03-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078527-001FLUMAZENIL0.5MG/5ML (0.1MG/ML)INJECTABLE / INJECTIONAP2009-03-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078527-002FLUMAZENIL1MG/10ML (0.1MG/ML)INJECTABLE / INJECTIONAPRS2009-03-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078527-001FLUMAZENIL0.5MG/5ML (0.1MG/ML)INJECTABLE / INJECTIONAP2009-03-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078527-002FLUMAZENIL1MG/10ML (0.1MG/ML)INJECTABLE / INJECTIONAPRS2009-03-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078527-001FLUMAZENIL0.5MG/5ML (0.1MG/ML)INJECTABLE / INJECTIONAP2009-03-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078527-002FLUMAZENIL1MG/10ML (0.1MG/ML)INJECTABLE / INJECTIONAPRS2009-03-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078527-001FLUMAZENIL0.5MG/5ML (0.1MG/ML)INJECTABLE / INJECTIONAP2009-03-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078527-002FLUMAZENIL1MG/10ML (0.1MG/ML)INJECTABLE / INJECTIONAPRS2009-03-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078527-001FLUMAZENIL0.5MG/5ML (0.1MG/ML)INJECTABLE / INJECTIONAP2009-03-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078527-002FLUMAZENIL1MG/10ML (0.1MG/ML)INJECTABLE / INJECTIONAPRS2009-03-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078527-001FLUMAZENIL0.5MG/5ML (0.1MG/ML)INJECTABLE / INJECTIONAP2009-03-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A078527-002FLUMAZENIL1MG/10ML (0.1MG/ML)INJECTABLE / INJECTIONAPRS2009-03-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078527-001FLUMAZENIL0.5MG/5ML (0.1MG/ML)INJECTABLE / INJECTIONAP2009-03-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078527-002FLUMAZENIL1MG/10ML (0.1MG/ML)INJECTABLE / INJECTIONAPRS2009-03-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078527-001FLUMAZENIL0.5MG/5ML (0.1MG/ML)INJECTABLE / INJECTIONAP2009-03-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078527-002FLUMAZENIL1MG/10ML (0.1MG/ML)INJECTABLE / INJECTIONAPRS2009-03-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078527-001FLUMAZENIL0.5MG/5ML (0.1MG/ML)INJECTABLE / INJECTIONAP2009-03-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078527-002FLUMAZENIL1MG/10ML (0.1MG/ML)INJECTABLE / INJECTIONAPRS2009-03-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078527-001FLUMAZENIL0.5MG/5ML (0.1MG/ML)INJECTABLE / INJECTIONAP2009-03-238072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078527-002FLUMAZENIL1MG/10ML (0.1MG/ML)INJECTABLE / INJECTIONAPRS2009-03-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078527-001FLUMAZENIL0.5MG/5ML (0.1MG/ML)INJECTABLE / INJECTIONAP2009-03-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078527-002FLUMAZENIL1MG/10ML (0.1MG/ML)INJECTABLE / INJECTIONAPRS2009-03-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078527-001FLUMAZENIL0.5MG/5ML (0.1MG/ML)INJECTABLE / INJECTIONAP2009-03-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078527-002FLUMAZENIL1MG/10ML (0.1MG/ML)INJECTABLE / INJECTIONAPRS2009-03-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078527-001FLUMAZENIL0.5MG/5ML (0.1MG/ML)INJECTABLE / INJECTIONAP2009-03-234b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078527-002FLUMAZENIL1MG/10ML (0.1MG/ML)INJECTABLE / INJECTIONAPRS2009-03-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078527-001FLUMAZENIL0.5MG/5ML (0.1MG/ML)INJECTABLE / INJECTIONAP2009-03-2374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078527-002FLUMAZENIL1MG/10ML (0.1MG/ML)INJECTABLE / INJECTIONAPRS2009-03-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078527-001FLUMAZENIL0.5MG/5ML (0.1MG/ML)INJECTABLE / INJECTIONAP2009-03-23bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078527-002FLUMAZENIL1MG/10ML (0.1MG/ML)INJECTABLE / INJECTIONAPRS2009-03-23bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A078527-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A078527-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078527-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078527-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078527-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078527-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078527-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078527-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078527-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078527-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078527-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078527-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078527-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078527-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078527-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078527-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078527-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078527-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078527-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078527-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078527-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078527-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078527-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078527-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078527-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078527-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078527-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078527-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078527-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078527-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078527-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078527-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078527-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078527-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078527-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078527-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078527-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078527-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078527-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078527-002AP1bb7c543d1eb4…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
40P7XK9392Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
204508Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1855bb03-392f-4a0d-8361-24fc2a0e635eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
0404-9793-05FLUMAZENIL1 in 1 BAGINJECTION, SOLUTION11
0404-9793-05FLUMAZENIL5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-9793FLUMAZENIL INJECTION, SOLUTION [HENRY SCHEIN, INC.]1Current NDC, 2 package rows20250221_1855bb03-392f-4a0d-8361-24fc2a0e635e.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FLUMAZENILFLUMAZENILHF Acquisition Co. LLC, DBA HealthFirst74d007e9-9604-0941-e053-2a91aa0a29c42026-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078527
application number: ANDA078527
FlumazenilFLUMAZENILProPharma Distribution3eefb01b-3d6a-a3eb-e063-6394a90a48292025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078527
application number: ANDA078527
FlumazenilFLUMAZENILProPharma Distribution3f7a30b5-2728-0c82-e063-6394a90a92dd2025-09-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078527
application number: ANDA078527
FLUMAZENILFLUMAZENILHenry Schein, Inc.1855bb03-392f-4a0d-8361-24fc2a0e635e2025-02-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078527
application number: ANDA078527
ndc (product): 0404-9793
FLUMAZENILFLUMAZENILHenry Schein, Inc.3ea41cbe-bc07-4c95-8bb2-7dfc2e96a8742025-02-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078527
application number: ANDA078527
FlumazenilFLUMAZENILHikma Pharmaceuticals USA Inc.436f5616-9626-4b6a-9deb-2986444179d02024-06-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078527
application number: ANDA078527
FlumazenilFLUMAZENILA-S Medication Solutions2190e8d0-d7ca-4f53-b243-0d2c31979aa82024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078527
application number: ANDA078527
FlumazenilFLUMAZENILHikma Pharmaceuticals USA Inc.442ed32b-b508-40cc-9915-ff05674566da2024-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078527
application number: ANDA078527
FLUMAZENILFLUMAZENILHF Acquisition Co. LLC, DBA Health First744ef484-ef46-8d62-e053-2a91aa0a0c052024-01-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078527
application number: ANDA078527
FlumazenilFLUMAZENILMedical Purchasing Solutions, LLC6673efde-057a-a889-e053-2a91aa0a517b2023-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078527
application number: ANDA078527
FlumazenilFLUMAZENILMedical Purchasing Solutions, LLC6671d89f-cc82-c03c-e053-2a91aa0aa5fa2022-10-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078527
application number: ANDA078527

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204508flumazenil 0.1 MG/ML Injectable SolutionPSN1855bb03-392f-4a0d-8361-24fc2a0e635e1
204508flumazenil 0.1 MG/ML Injectable SolutionSCD1855bb03-392f-4a0d-8361-24fc2a0e635e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0404-9793-05004049793051 VIAL, MULTI-DOSE in 1 BAG (0404-9793-05) / 5 mL in 1 VIAL, MULTI-DOSE2025-02-14NoNoCurrent