Home NDC 36000-149 Flumazenil
Product NDC 36000-149
11-digit product format 360000149
Labeler code 36000
Product ID 36000-149_f84ae313-68b9-444b-83de-d9f50157dad2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Flumazenil
Dosage form INJECTION
Route INTRAVENOUS
Labeler Baxter Healthcare Corporation
Application ANDA076755
Marketing category ANDA
Marketing start 2017-10-01
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 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 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 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.
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 36000-149-05 Flumazenil 10 mL in 1 VIAL, MULTI-DOSE INJECTION 10 17 36000-149-05 Flumazenil 5 in 1 PACKAGE INJECTION 5 17 36000-149-10 Flumazenil 10 in 1 PACKAGE INJECTION 10 17 36000-149-10 Flumazenil 10 mL in 1 VIAL, MULTI-DOSE INJECTION 10 17
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36000-149 FLUMAZENIL INJECTION [BAXTER HEALTHCARE CORPORATION] 16 Current NDC, Legacy NDC, 4 package rows 20240921_8175c1eb-80af-48f1-813c-c8f0e736d894.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 ndc (product): 36000-149
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 36000-149-05 36000014905 10 mL in 1 VIAL, MULTI-DOSE 10 ml Historical 36000-149-10 36000014910 10 VIAL, MULTI-DOSE in 1 PACKAGE (36000-149-10) / 10 mL in 1 VIAL, MULTI-DOSE 2017-10-01 0000-00-00 No No Current