Home NDC 63323-424 Flumazenil
Product NDC 63323-424
11-digit product format 633230424
Labeler code 63323
Product ID 63323-424_9f9520ae-2135-4731-8fb2-8a0a771c302b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FLUMAZENIL
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA076955
Marketing category ANDA
Marketing start 2005-04-05
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 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 63323-424-01 Flumazenil 5 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 5 5 63323-424-05 Flumazenil 10 in 1 TRAY INJECTION, SOLUTION 10 5 63323-424-10 Flumazenil 1 in 1 CARTON INJECTION, SOLUTION 1 5 63323-424-10 Flumazenil 10 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 10 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FLUMAZENIL ACTIVE INGREDIENT 40P7XK9392 FLUMAZENIL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 FLUMAZENIL ACTIVE MOIETY 40P7XK9392 FLUMAZENIL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 ACETIC ACID INACTIVE INGREDIENT Q40Q9N063P FLUMAZENIL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K FLUMAZENIL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB FLUMAZENIL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T FLUMAZENIL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH FLUMAZENIL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X FLUMAZENIL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I FLUMAZENIL INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-424 FLUMAZENIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 5 Current NDC, Legacy NDC, 4 package rows 20250416_a72d9fc1-121c-455d-93a9-002378c9968f.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 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
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 63323-424-01 63323042401 5 mL in 1 VIAL, MULTI-DOSE 5 ml Historical 63323-424-05 63323042405 10 VIAL, MULTI-DOSE in 1 TRAY (63323-424-05) / 5 mL in 1 VIAL, MULTI-DOSE (63323-424-01) 2005-04-05 0000-00-00 No No Current 63323-424-10 63323042410 1 VIAL, MULTI-DOSE in 1 CARTON (63323-424-10) / 10 mL in 1 VIAL, MULTI-DOSE 2005-04-05 0000-00-00 No No Current