Flumazenil

Product NDC: 71872-7008
Requested package NDC: 71872-7008-1
11-digit product format: 718727008
Labeler code: 71872
Product ID: 71872-7008_eaeea17c-3d8f-d4eb-e053-2a95a90a9541
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: flumazenil
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Medical Purchasing Solutions, LLC
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A078527-001	FLUMAZENIL	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23
A078527-002	FLUMAZENIL	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078527-001	AP
A078527-002	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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078527-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078527-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078527-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078527-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078527-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078527-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078527-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078527-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078527-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078527-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078527-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078527-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078527-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078527-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078527-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078527-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078527-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078527-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078527-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078527-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078527-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078527-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078527-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078527-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078527-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078527-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078527-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078527-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078527-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078527-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078527-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078527-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078527-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078527-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078527-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078527-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078527-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078527-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078527-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078527-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078527-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078527-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078527-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078527-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078527-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078527-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078527-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078527-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078527-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078527-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078527-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078527-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078527-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078527-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078527-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078527-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078527-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078527-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078527-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078527-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078527-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078527-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078527-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078527-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078527-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078527-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078527-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078527-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078527-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078527-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078527-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078527-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078527-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078527-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078527-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078527-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078527-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078527-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078527-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078527-002	AP	1	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUMAZENIL	.1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
40P7XK9392	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
6671d89f-cc82-c03c-e053-2a91aa0aa5fa	Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71872-7008-1	Flumazenil	10 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	10		3
71872-7008-1	Flumazenil	1 in 1 BAG	INJECTION, SOLUTION	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71872-7008	FLUMAZENIL INJECTION, SOLUTION [MEDICAL PURCHASING SOLUTIONS, LLC]	3	Current NDC, Legacy NDC, 2 package rows	20221014_6671d89f-cc82-c03c-e053-2a91aa0aa5fa.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FLUMAZENIL	FLUMAZENIL	HF Acquisition Co. LLC, DBA HealthFirst	74d007e9-9604-0941-e053-2a91aa0a29c4	2026-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078527 application number: ANDA078527
Flumazenil	FLUMAZENIL	ProPharma Distribution	3eefb01b-3d6a-a3eb-e063-6394a90a4829	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078527 application number: ANDA078527
Flumazenil	FLUMAZENIL	ProPharma Distribution	3f7a30b5-2728-0c82-e063-6394a90a92dd	2025-09-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078527 application number: ANDA078527
FLUMAZENIL	FLUMAZENIL	Henry Schein, Inc.	1855bb03-392f-4a0d-8361-24fc2a0e635e	2025-02-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078527 application number: ANDA078527
FLUMAZENIL	FLUMAZENIL	Henry Schein, Inc.	3ea41cbe-bc07-4c95-8bb2-7dfc2e96a874	2025-02-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078527 application number: ANDA078527
Flumazenil	FLUMAZENIL	Hikma Pharmaceuticals USA Inc.	436f5616-9626-4b6a-9deb-2986444179d0	2024-06-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078527 application number: ANDA078527
Flumazenil	FLUMAZENIL	A-S Medication Solutions	2190e8d0-d7ca-4f53-b243-0d2c31979aa8	2024-06-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078527 application number: ANDA078527
Flumazenil	FLUMAZENIL	Hikma Pharmaceuticals USA Inc.	442ed32b-b508-40cc-9915-ff05674566da	2024-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078527 application number: ANDA078527
FLUMAZENIL	FLUMAZENIL	HF Acquisition Co. LLC, DBA Health First	744ef484-ef46-8d62-e053-2a91aa0a0c05	2024-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078527 application number: ANDA078527
Flumazenil	FLUMAZENIL	Medical Purchasing Solutions, LLC	6673efde-057a-a889-e053-2a91aa0a517b	2023-05-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078527 application number: ANDA078527
Flumazenil	FLUMAZENIL	Medical Purchasing Solutions, LLC	6671d89f-cc82-c03c-e053-2a91aa0aa5fa	2022-10-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078527 application number: ANDA078527 ndc (package): 71872-7008-1 ndc (product): 71872-7008 ndc11 (package): 71872700801

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
204508	flumazenil 0.1 MG/ML Injectable Solution	PSN	6671d89f-cc82-c03c-e053-2a91aa0aa5fa	3
204508	flumazenil 0.1 MG/ML Injectable Solution	SCD	6671d89f-cc82-c03c-e053-2a91aa0aa5fa	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71872-7008-1	71872700801	1 VIAL, MULTI-DOSE in 1 BAG (71872-7008-1) / 10 mL in 1 VIAL, MULTI-DOSE	2018-02-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FLUMAZENIL INJECTION, USP	Medical Purchasing Solutions, LLC	2022-10-13	HUMAN PRESCRIPTION DRUG LABEL	3