Home Applications 064125 Application 064125
Type ANDA
Sponsor ACS DOBFAR SPA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CEFUROXIME SODIUM CEFUROXIME SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 750MG BASE/VIAL No No 002 CEFUROXIME SODIUM CEFUROXIME SODIUM INJECTABLE;INJECTION EQ 1.5GM BASE/VIAL No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A064125-001 CEFUROXIME SODIUM CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 A064125-002 CEFUROXIME SODIUM CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30
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 · 82 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 A064125-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A064125-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A064125-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A064125-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A064125-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A064125-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A064125-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A064125-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A064125-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A064125-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A064125-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A064125-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A064125-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A064125-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A064125-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A064125-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A064125-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A064125-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A064125-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A064125-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A064125-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A064125-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A064125-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A064125-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A064125-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A064125-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A064125-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A064125-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A064125-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A064125-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A064125-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A064125-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A064125-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A064125-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A064125-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A064125-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A064125-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A064125-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A064125-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 1997-05-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A064125-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 1997-05-30 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
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 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 16 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 25021-118 Cefuroxime sodium Cefuroxime sodium Sagent Pharmaceuticals ANDA Current 25021-118 Cefuroxime sodium Cefuroxime sodium Sagent Pharmaceuticals ANDA Current 25021-118 Cefuroxime Sodium Cefuroxime Sodium Sagent Pharmaceuticals ANDA Current 25021-118 Cefuroxime sodium Cefuroxime sodium Sagent Pharmaceuticals ANDA Current 25021-119 Cefuroxime sodium Cefuroxime sodium Sagent Pharmaceuticals ANDA Current 25021-119 Cefuroxime sodium Cefuroxime sodium Sagent Pharmaceuticals ANDA Current 25021-119 Cefuroxime Sodium Cefuroxime Sodium Sagent Pharmaceuticals ANDA Current 25021-119 Cefuroxime sodium Cefuroxime sodium Sagent Pharmaceuticals ANDA Current 25021-182 Cefuroxime sodium Cefuroxime sodium Sagent Pharmaceuticals ANDA Current 25021-182 Cefuroxime Sodium Cefuroxime Sodium Sagent Pharmaceuticals ANDA Current 25021-183 Cefuroxime sodium Cefuroxime sodium Sagent Pharmaceuticals ANDA Current 25021-183 Cefuroxime Sodium Cefuroxime Sodium Sagent Pharmaceuticals ANDA Current 44567-710 Cefuroxime Cefuroxime WG Critical Care, LLC ANDA Current 44567-711 Cefuroxime Cefuroxime WG Critical Care, LLC ANDA Current 44567-720 Cefuroxime Cefuroxime WG Critical Care, LLC ANDA Current 44567-722 Cefuroxime Cefuroxime WG Critical Care, LLC ANDA Current