Flumazenil

Product NDC: 0781-3003
11-digit product format: 007813003
Labeler code: 0781
Product ID: 0781-3003_37418d42-f4fc-4f86-a9d2-4b33b85c4460
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Flumazenil
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Sandoz Inc
Application: ANDA077071
Marketing category: ANDA
Marketing start: 2005-05-03
Marketing end: 0000-00-00
Substance: FLUMAZENIL
Active strength: 0 mg/mL
Pharmacologic classes: Benzodiazepine Antagonist [EPC]
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0781-3003		D	Discontinued by firm	2026-08-17
excluded package	package	0781-3003	0781-3003-92	D	Discontinued by firm	2026-08-17
excluded package	package	0781-3003	0781-3003-95	D	Discontinued by firm	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0781-3003-95	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0781-3003-92	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0781-3003-95	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0781-3003-92	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0781-3003-95	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0781-3003-92	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0781-3003-95	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0781-3003-92	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0781-3003-95	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0781-3003-92	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0781-3003-95	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0781-3003-92	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0781-3003-95	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0781-3003-92	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0781-3003-95	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0781-3003-92	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0781-3003-95	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0781-3003-92	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0781-3003-95	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0781-3003-92	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0781-3003-95	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0781-3003-92	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0781-3003-95	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0781-3003-92	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A077071-001	FLUMAZENIL	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2005-05-03
A077071-002	FLUMAZENIL	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2005-05-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077071-001	AP
A077071-002	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	A077071-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2005-05-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077071-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2005-05-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077071-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2005-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077071-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2005-05-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077071-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2005-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077071-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2005-05-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077071-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2005-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077071-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2005-05-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077071-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2005-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077071-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2005-05-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077071-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2005-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077071-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2005-05-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077071-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2005-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077071-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2005-05-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077071-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2005-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077071-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2005-05-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077071-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2005-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077071-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2005-05-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077071-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2005-05-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077071-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2005-05-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077071-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2005-05-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077071-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2005-05-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077071-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2005-05-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077071-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2005-05-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077071-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2005-05-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077071-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2005-05-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077071-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2005-05-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077071-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2005-05-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077071-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2005-05-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077071-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2005-05-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077071-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2005-05-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077071-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2005-05-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077071-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2005-05-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077071-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2005-05-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077071-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2005-05-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077071-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2005-05-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077071-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2005-05-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077071-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2005-05-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077071-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2005-05-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077071-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2005-05-03	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A077071-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077071-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077071-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077071-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077071-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077071-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077071-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077071-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077071-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077071-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077071-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077071-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077071-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077071-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077071-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077071-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077071-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077071-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077071-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077071-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077071-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077071-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077071-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077071-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077071-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077071-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077071-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077071-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077071-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077071-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077071-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077071-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077071-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077071-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077071-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077071-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077071-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077071-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077071-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077071-002	AP	1	`bb7c543d1eb4…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-3003-70	ML - Milliliter	0781-3003	c5bea606-8733-403f-9922-27e7cac36f13	1	2012-07-24
0781-3003-75	ML - Milliliter	0781-3003	05b8546b-a7c0-4026-a387-1c23686a3b14	1	2012-07-24
0781-3003-92	ML - Milliliter	0781-3003	733f9055-a903-4ed2-b48c-7d44cb248059	1	2012-07-24
0781-3003-95	ML - Milliliter	0781-3003	a6c41535-8339-4e65-88d7-dcfa7adbfaed	1	2012-07-24