Home NDC 70710-1478 Fomepizole
Product NDC 70710-1478
11-digit product format 707101478
Labeler code 70710
Product ID 70710-1478_62ff03a3-fb25-41d8-9c6c-d1ad61ea3d31
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fomepizole
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA078537
Marketing category ANDA
Marketing start 2021-03-18
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 A078537-001 FOMEPIZOLE FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2008-03-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078537-001 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 A078537-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2008-03-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078537-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2008-03-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078537-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2008-03-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078537-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2008-03-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078537-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2008-03-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078537-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2008-03-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078537-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2008-03-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078537-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2008-03-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078537-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2008-03-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078537-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2008-03-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078537-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2008-03-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078537-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2008-03-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078537-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2008-03-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078537-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2008-03-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078537-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2008-03-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078537-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2008-03-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078537-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2008-03-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078537-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2008-03-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078537-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2008-03-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078537-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2008-03-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078537-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2008-03-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078537-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2008-03-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078537-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2008-03-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078537-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2008-03-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078537-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2008-03-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078537-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2008-03-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078537-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2008-03-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078537-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2008-03-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078537-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2008-03-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078537-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2008-03-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078537-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2008-03-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078537-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2008-03-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078537-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2008-03-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078537-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2008-03-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078537-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2008-03-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078537-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2008-03-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078537-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2008-03-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078537-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2008-03-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078537-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2008-03-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078537-001 FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE / INJECTION AP 2008-03-06 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 70710-1478-1 Fomepizole 1 in 1 CARTON INJECTION, SOLUTION 1 8 70710-1478-1 Fomepizole 1.5 mL in 1 VIAL INJECTION, SOLUTION 1.5 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70710-1478 FOMEPIZOLE INJECTION, SOLUTION [ZYDUS PHARMACEUTICALS USA INC.] 7 Current NDC, Legacy NDC, 2 package rows 20241222_256910fe-91f2-48f6-b0b4-55edc52dacd4.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 70710-1478-1 70710147801 1 VIAL in 1 CARTON (70710-1478-1) / 1.5 mL in 1 VIAL 1 vial 2021-03-18 0000-00-00 No No Current