Home NDC 0517-0710 fomepizole
Product NDC 0517-0710
11-digit product format 005170710
Labeler code 0517
Product ID 0517-0710_aac796de-58f6-49e5-b959-f95b0c7b8889
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fomepizole
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler American Regent, Inc.
Application ANDA078368
Marketing category ANDA
Marketing start 2020-07-31
Substance FOMEPIZOLE
Active strength 1 g/mL
Pharmacologic classes Antidote [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 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078368-001 FOMEPIZOLE FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2007-12-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078368-001 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 2 · 41 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 2026-02-19 14:30 UTC 2026-02 A078368-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2007-12-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078368-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2007-12-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078368-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2007-12-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078368-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2007-12-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078368-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2007-12-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078368-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2007-12-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078368-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2007-12-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078368-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2007-12-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078368-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2007-12-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078368-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2007-12-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078368-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2007-12-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078368-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2007-12-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078368-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2007-12-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078368-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2007-12-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078368-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2007-12-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078368-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2007-12-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078368-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2007-12-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078368-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2007-12-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078368-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2007-12-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078368-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2007-12-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078368-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2007-12-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078368-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2007-12-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078368-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2007-12-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078368-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2007-12-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078368-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2007-12-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078368-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2007-12-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078368-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2007-12-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078368-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2007-12-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078368-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2007-12-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078368-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2007-12-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078368-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2007-12-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078368-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2007-12-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078368-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2007-12-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078368-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2007-12-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078368-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2007-12-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078368-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2007-12-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078368-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2007-12-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078368-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2007-12-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078368-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2007-12-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078368-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2007-12-14 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base fomepizole
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FOMEPIZOLE 1 g/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 83LCM6L2BY Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310414 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 0517-0710-01 fomepizole 1.5 mL in 1 VIAL INJECTION, SOLUTION 1.5 4 0517-0710-01 fomepizole 1 in 1 CARTON INJECTION, SOLUTION 1 4 0517-0710-88 fomepizole 1 in 1 CARTON INJECTION, SOLUTION 1 4 0517-0710-88 fomepizole 1.5 mL in 1 VIAL INJECTION, SOLUTION 1.5 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0517-0710 FOMEPIZOLE INJECTION, SOLUTION [AMERICAN REGENT, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20210126_a31d0148-2729-49de-b666-f24b0dfd2401.zip 0517-0710 FOMEPIZOLE INJECTION, SOLUTION [AMERICAN REGENT, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20210126_82dc2920-af7f-4e43-9f6d-8877a71884cd.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 · 2 matching rows.
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 0517-0710-01 00517071001 1 VIAL in 1 CARTON (0517-0710-01) / 1.5 mL in 1 VIAL 1 vial 2018-07-16 0000-00-00 No No Current 0517-0710-88 00517071088 1 VIAL in 1 CARTON (0517-0710-88) / 1.5 mL in 1 VIAL 1 vial 2020-07-31 0000-00-00 No No Current