Home NDC 0404-9860 Flumazenil
Product NDC 0404-9860
11-digit product format 004049860
Labeler code 0404
Product ID 0404-9860_7ffd4deb-5b2a-4f5a-9fae-fe764f86fcf9
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 2026-07-31
Substance FLUMAZENIL
Active strength .1 mg/mL
Pharmacologic classes Benzodiazepine Antagonist [EPC]
NDC exclude flag No
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-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.
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 RLD / RS 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0404-9860-05 Flumazenil 1 in 1 BAG INJECTION 1 5 0404-9860-05 Flumazenil 5 mL in 1 VIAL, MULTI-DOSE INJECTION 5 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0404-9860 FLUMAZENIL INJECTION [HENRY SCHEIN, INC] 4 Current NDC, Legacy NDC, 2 package rows 20240529_904f7154-433a-4ea1-b622-acf79568d96b.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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0404-9860-05 00404986005 1 VIAL, MULTI-DOSE in 1 BAG (0404-9860-05) / 5 mL in 1 VIAL, MULTI-DOSE 2022-01-10 2026-07-31 No No Current