Flumazenil

Product NDC: 0404-9859
Requested package NDC: 0404-9859-10
11-digit product format: 004049859
Labeler code: 0404
Product ID: 0404-9859_b8514d93-48a3-4e73-8dc4-edacdfd45627
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: flumazenil
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Henry Schein, Inc
Application: ANDA076755
Marketing category: ANDA
Marketing start: 2022-01-10
Marketing end: 0000-00-00
Substance: FLUMAZENIL
Active strength: 0 mg/mL
Pharmacologic classes: Benzodiazepine Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0404-9859	0404-9859-10	D	Discontinued by firm		2026-08-17

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076755-001	FLUMAZENIL	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2004-10-12
A076755-002	FLUMAZENIL	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2004-10-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076755-001	AP
A076755-002	AP

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076755-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076755-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076755-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076755-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076755-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076755-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076755-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076755-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076755-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076755-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076755-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076755-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076755-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076755-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076755-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076755-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076755-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076755-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076755-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076755-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076755-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076755-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076755-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076755-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076755-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076755-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076755-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076755-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076755-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076755-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076755-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076755-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076755-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076755-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076755-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076755-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076755-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION		2004-10-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076755-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION		2004-10-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076755-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076755-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A076755-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076755-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076755-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076755-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076755-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076755-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076755-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076755-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076755-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076755-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076755-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076755-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076755-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076755-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076755-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076755-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076755-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076755-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076755-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076755-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076755-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076755-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076755-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076755-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076755-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076755-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076755-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076755-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076755-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076755-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076755-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076755-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076755-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076755-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076755-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076755-002	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A076755-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076755-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076755-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076755-002	AP	1	`782e0a99824c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0404-9859	FLUMAZENIL INJECTION [HENRY SCHEIN, INC]	4	Legacy NDC	20240601_54abb0b0-8223-451b-a4f8-bccd1a7f429a.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Flumazenil	FLUMAZENIL	Medical Purchasing Solutions, LLC	28f31b54-ff30-fd0d-e063-6394a90afc18	2024-12-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076755 application number: ANDA076755
Flumazenil	FLUMAZENIL	Medical Purchasing Solutions, LLC	9f68c61a-c207-cdbe-e053-2a95a90af5a0	2023-05-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076755 application number: ANDA076755
Flumazenil	FLUMAZENIL	Baxter Healthcare Corporation	8175c1eb-80af-48f1-813c-c8f0e736d894	2020-01-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076755 application number: ANDA076755

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
40P7XK9392	FLUMAZENIL	78755-81-4	FLUMAZENIL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0404-9859-10	00404985910	1 VIAL, MULTI-DOSE in 1 BAG (0404-9859-10) > 10 mL in 1 VIAL, MULTI-DOSE	2022-01-10	0000-00-00	No	No	Current