Home NDC 51662-1579 FLUMAZENIL
Product NDC 51662-1579
11-digit product format 516621579
Labeler code 51662
Product ID 51662-1579_c5da455f-3214-ab11-e053-2995a90a54ee
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FLUMAZENIL
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler HF Acquisition Co LLC, DBA HealthFirst
Application ANDA076955
Marketing category ANDA
Marketing start 2021-06-28
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 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.
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 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.
Additional Listing Data#
Finished product Yes
Brand name base FLUMAZENIL
Listing expiration 2027-12-31 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 51662-1579-1 FLUMAZENIL 5 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 5 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51662-1579 FLUMAZENIL INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] 1 Current NDC, Legacy NDC, 1 package rows 20210629_c5da455f-3213-ab11-e053-2995a90a54ee.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 · 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
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 51662-1579-1 51662157901 5 mL in 1 VIAL, MULTI-DOSE (51662-1579-1) 5 ml 2021-06-28 0000-00-00 No No Current 51662-1579-3 51662157903 10 POUCH in 1 CASE (51662-1579-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1579-2) / 5 mL in 1 VIAL, MULTI-DOSE (51662-1579-1) 10 pouch 2021-06-28 0 Current