Home NDC 0143-9568 Cefuroxime
Product NDC 0143-9568
11-digit product format 001439568
Labeler code 0143
Product ID 0143-9568_e43d5edd-fd78-43d3-b8d2-4b22b7541042
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefuroxime
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA065048
Marketing category ANDA
Marketing start 2004-01-09
Substance CEFUROXIME SODIUM
Active strength 750 mg/1
Pharmacologic classes Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
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 A065048-001 CEFUROXIME SODIUM CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB RS 2004-01-09 A065048-002 CEFUROXIME SODIUM CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP RS 2004-01-09
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 A065048-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB RS 2004-01-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065048-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP RS 2004-01-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065048-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB RS 2004-01-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065048-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP RS 2004-01-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065048-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB RS 2004-01-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065048-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP RS 2004-01-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065048-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB RS 2004-01-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065048-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP RS 2004-01-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065048-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB RS 2004-01-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065048-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP RS 2004-01-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065048-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB RS 2004-01-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065048-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP RS 2004-01-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065048-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB RS 2004-01-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065048-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP RS 2004-01-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065048-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB RS 2004-01-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065048-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP RS 2004-01-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065048-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB RS 2004-01-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065048-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP RS 2004-01-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065048-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB RS 2004-01-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065048-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP RS 2004-01-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065048-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB RS 2004-01-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065048-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP RS 2004-01-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065048-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB RS 2004-01-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065048-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP RS 2004-01-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065048-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB RS 2004-01-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065048-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP RS 2004-01-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065048-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB RS 2004-01-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065048-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP RS 2004-01-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065048-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB RS 2004-01-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065048-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP RS 2004-01-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065048-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 2004-01-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065048-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 2004-01-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065048-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 2004-01-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065048-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 2004-01-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065048-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 2004-01-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065048-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 2004-01-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065048-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 2004-01-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065048-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 2004-01-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065048-001 CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AB 2004-01-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065048-002 CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION AP 2004-01-09 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 Cefuroxime
Listing expiration 2026-12-31 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 0143-9568-01 Cefuroxime 1 in 1 VIAL INJECTION, POWDER, FOR SOLUTION 1 3 0143-9568-25 Cefuroxime 25 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 25 3
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9568 CEFUROXIME INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 3 Current NDC, Legacy NDC, 2 package rows 20220820_19902965-d2d6-433f-982d-0095014df4e8.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 0143-9568-01 00143956801 1 in 1 VIAL Historical 0143-9568-25 00143956825 25 VIAL in 1 CARTON (0143-9568-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9568-01) 25 vial 2004-01-09 0000-00-00 No No Current