Application 076955

Type: ANDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUMAZENIL	FLUMAZENIL	INJECTABLE;INJECTION	1MG/10ML (0.1MG/ML)	No	No
002	FLUMAZENIL	FLUMAZENIL	INJECTABLE;INJECTION	0.5MG/5ML (0.1MG/ML)	No	No

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
A076955-001	FLUMAZENIL	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2004-10-12
A076955-002	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
A076955-001	AP
A076955-002	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	A076955-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076955-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076955-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076955-002	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	A076955-001	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	A076955-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076955-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076955-002	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	A076955-001	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	A076955-002	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	A076955-001	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	A076955-002	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	A076955-001	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	A076955-002	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	A076955-001	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	A076955-002	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	A076955-001	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	A076955-002	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	A076955-001	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	A076955-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076955-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076955-002	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	A076955-001	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	A076955-002	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	A076955-001	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	A076955-002	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	A076955-001	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	A076955-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076955-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076955-002	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	A076955-001	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	A076955-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076955-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076955-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076955-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076955-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076955-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076955-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076955-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076955-002	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 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	A076955-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076955-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076955-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076955-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076955-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076955-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076955-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076955-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076955-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076955-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076955-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076955-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076955-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076955-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076955-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076955-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076955-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076955-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076955-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076955-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076955-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076955-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076955-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076955-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076955-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076955-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076955-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076955-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076955-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076955-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076955-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076955-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076955-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076955-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076955-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076955-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076955-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076955-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076955-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076955-002	AP	1	`bb7c543d1eb4…`

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 · 4 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	56452ba8-521d-1f84-e063-6294a90af6fc	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076955 application number: ANDA076955
FLUMAZENIL	FLUMAZENIL	HF Acquisition Co LLC, DBA HealthFirst	c5da455f-3213-ab11-e053-2995a90a54ee	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076955 application number: ANDA076955 ndc (product): 51662-1579
Flumazenil	FLUMAZENIL	Medical Purchasing Solutions, LLC	53d9144a-b7ee-b52a-e063-6294a90a09c5	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076955 application number: ANDA076955
Flumazenil	FLUMAZENIL	Fresenius Kabi USA, LLC	a72d9fc1-121c-455d-93a9-002378c9968f	2025-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076955 application number: ANDA076955 ndc (product): 63323-424

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51662-1579	FLUMAZENIL	FLUMAZENIL	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
63323-424	Flumazenil	FLUMAZENIL	Fresenius Kabi USA, LLC	ANDA	Current
63323-424	Flumazenil	FLUMAZENIL	Fresenius Kabi USA, LLC	ANDA	Current
70518-3456	Flumazenil	FLUMAZENIL	REMEDYREPACK INC.	ANDA	Current