Home NDC 25021-118 Cefuroxime sodium
Product NDC 25021-118
11-digit product format 250210118
Labeler code 25021
Product ID 25021-118_da170a9c-def7-432b-8999-701e7b878fe8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefuroxime sodium
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Sagent Pharmaceuticals
Application ANDA064125
Marketing category ANDA
Marketing start 2016-09-01
Substance CEFUROXIME SODIUM
Active strength 750 mg/1
Pharmacologic classes Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 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.
Additional Listing Data#
Finished product Yes
Brand name base Cefuroxime sodium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEFUROXIME SODIUM 750 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R8A7M9MY61 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1665444 Internal RxNorm lookup 1665449 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 25021-118-10 Cefuroxime sodium 25 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 25 10 25021-118-10 Cefuroxime sodium 1 in 1 VIAL INJECTION, POWDER, FOR SOLUTION 1 10
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 25021-118 CEFUROXIME SODIUM INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS] 9 Current NDC, Legacy NDC, 2 package rows 20250304_0a145288-733a-4966-b7ae-dc96eb103d8c.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 · 1 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 25021-118-10 25021011810 25 VIAL in 1 CARTON (25021-118-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL 25 vial 2016-09-01 0000-00-00 No No Current