Home NDC 67457-447 Flumazenil
Product NDC 67457-447
11-digit product format 674570447
Labeler code 67457
Product ID 67457-447_0a508dbb-3679-4f85-87c7-833eafb65ed6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Flumazenil
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Mylan Institutional LLC
Application ANDA078595
Marketing category ANDA
Marketing start 2011-05-10
Marketing end 2021-11-30
Substance FLUMAZENIL
Active strength 0 mg/mL
Pharmacologic classes Benzodiazepine Antagonist [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record 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 · 24 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 67457-447-53 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 67457-447-53 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 67457-447-53 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 67457-447-53 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 67457-447-53 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 67457-447-53 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 67457-447-53 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 67457-447-53 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 67457-447-53 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 67457-447-53 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 67457-447-53 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 67457-447-53 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A078595-001 FLUMAZENIL FLUMAZENIL 0.5MG/5ML (0.1MG/ML) INJECTABLE / INJECTION AP 2008-05-13 A078595-002 FLUMAZENIL FLUMAZENIL 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION 2008-05-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078595-001 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 · 88 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 2026-10-15 13:18:30 2026-09 A078595-001 FLUMAZENIL 0.5MG/5ML (0.1MG/ML) INJECTABLE / INJECTION AP 2008-05-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078595-002 FLUMAZENIL 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION 2008-05-13 c2088c7a36db…2026-09-14 22:38:34 2026-08 A078595-001 FLUMAZENIL 0.5MG/5ML (0.1MG/ML) INJECTABLE / INJECTION AP 2008-05-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078595-002 FLUMAZENIL 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION 2008-05-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078595-001 FLUMAZENIL 0.5MG/5ML (0.1MG/ML) INJECTABLE / INJECTION AP 2008-05-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078595-002 FLUMAZENIL 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION 2008-05-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078595-001 FLUMAZENIL 0.5MG/5ML (0.1MG/ML) INJECTABLE / INJECTION AP 2008-05-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078595-002 FLUMAZENIL 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION 2008-05-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078595-001 FLUMAZENIL 0.5MG/5ML (0.1MG/ML) INJECTABLE / INJECTION AP 2008-05-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078595-002 FLUMAZENIL 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION 2008-05-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078595-001 FLUMAZENIL 0.5MG/5ML (0.1MG/ML) INJECTABLE / INJECTION AP 2008-05-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078595-002 FLUMAZENIL 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION 2008-05-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078595-001 FLUMAZENIL 0.5MG/5ML (0.1MG/ML) INJECTABLE / INJECTION AP 2008-05-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078595-002 FLUMAZENIL 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION 2008-05-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078595-001 FLUMAZENIL 0.5MG/5ML (0.1MG/ML) INJECTABLE / INJECTION AP 2008-05-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078595-002 FLUMAZENIL 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION 2008-05-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078595-001 FLUMAZENIL 0.5MG/5ML (0.1MG/ML) INJECTABLE / INJECTION AP 2008-05-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078595-002 FLUMAZENIL 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION 2008-05-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078595-001 FLUMAZENIL 0.5MG/5ML (0.1MG/ML) INJECTABLE / INJECTION AP 2008-05-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078595-002 FLUMAZENIL 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION 2008-05-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078595-001 FLUMAZENIL 0.5MG/5ML (0.1MG/ML) INJECTABLE / INJECTION AP 2008-05-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078595-002 FLUMAZENIL 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION 2008-05-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078595-001 FLUMAZENIL 0.5MG/5ML (0.1MG/ML) INJECTABLE / INJECTION AP 2008-05-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078595-002 FLUMAZENIL 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION 2008-05-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078595-001 FLUMAZENIL 0.5MG/5ML (0.1MG/ML) INJECTABLE / INJECTION AP 2008-05-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078595-002 FLUMAZENIL 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION 2008-05-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078595-001 FLUMAZENIL 0.5MG/5ML (0.1MG/ML) INJECTABLE / INJECTION AP 2008-05-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078595-002 FLUMAZENIL 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION 2008-05-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078595-001 FLUMAZENIL 0.5MG/5ML (0.1MG/ML) INJECTABLE / INJECTION AP 2008-05-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078595-002 FLUMAZENIL 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION 2008-05-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078595-001 FLUMAZENIL 0.5MG/5ML (0.1MG/ML) INJECTABLE / INJECTION AP 2008-05-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078595-002 FLUMAZENIL 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION 2008-05-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078595-001 FLUMAZENIL 0.5MG/5ML (0.1MG/ML) INJECTABLE / INJECTION AP 2008-05-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078595-002 FLUMAZENIL 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION 2008-05-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078595-001 FLUMAZENIL 0.5MG/5ML (0.1MG/ML) INJECTABLE / INJECTION AP 2008-05-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078595-002 FLUMAZENIL 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION 2008-05-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078595-001 FLUMAZENIL 0.5MG/5ML (0.1MG/ML) INJECTABLE / INJECTION AP 2008-05-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078595-002 FLUMAZENIL 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION 2008-05-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078595-001 FLUMAZENIL 0.5MG/5ML (0.1MG/ML) INJECTABLE / INJECTION AP 2008-05-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078595-002 FLUMAZENIL 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION 2008-05-13 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 45 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FLUMAZENIL ACTIVE INGREDIENT 40P7XK9392 FLUMAZENIL INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC ] 1 FLUMAZENIL ACTIVE MOIETY 40P7XK9392 FLUMAZENIL INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC ] 1 ACETIC ACID INACTIVE INGREDIENT Q40Q9N063P FLUMAZENIL INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC ] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K FLUMAZENIL INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC ] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB FLUMAZENIL INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC ] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T FLUMAZENIL INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC ] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH FLUMAZENIL INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC ] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X FLUMAZENIL INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC ] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I FLUMAZENIL INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC ] 1 WATER INACTIVE INGREDIENT 059QF0KO0R FLUMAZENIL INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC ] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67457-447-53 67457044753 10 VIAL in 1 CARTON (67457-447-53) > 5 mL in 1 VIAL (67457-447-00) 10 vial 2011-05-10 2021-11-30 No No Current