Home NDC 0143-9976 Cefuroxime
Product NDC 0143-9976
11-digit product format 001439976
Labeler code 0143
Product ID 0143-9976_5621cde0-74c5-45b2-8f76-329eb22b4a0a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefuroxime
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA065046
Marketing category ANDA
Marketing start 2004-01-09
Substance CEFUROXIME SODIUM
Active strength 750 mg/8mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065046-001 CEFUROXIME SODIUM CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION 2004-01-09
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 · 42 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 A065046-001 CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION 2004-01-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065046-001 CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION 2004-01-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065046-001 CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION 2004-01-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065046-001 CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION 2004-01-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065046-001 CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION 2004-01-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065046-001 CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION 2004-01-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065046-001 CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION 2004-01-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065046-001 CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION 2004-01-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065046-001 CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION 2004-01-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065046-001 CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION 2004-01-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065046-001 CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION 2004-01-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065046-001 CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION 2004-01-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065046-001 CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION 2004-01-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065046-001 CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION 2004-01-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065046-001 CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION 2004-01-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065046-001 CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION AP 2004-01-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065046-001 CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION AP 2004-01-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065046-001 CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION AP 2004-01-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065046-001 CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION AP 2004-01-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065046-001 CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION AP 2004-01-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065046-001 CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION AP 2004-01-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065046-001 CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION AP 2004-01-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065046-001 CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION AP 2004-01-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065046-001 CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION AP 2004-01-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065046-001 CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION AP 2004-01-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065046-001 CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION AP 2004-01-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065046-001 CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION AP 2004-01-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065046-001 CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION AP 2004-01-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065046-001 CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION 2004-01-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065046-001 CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION 2004-01-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065046-001 CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION 2004-01-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065046-001 CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION 2004-01-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065046-001 CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION 2004-01-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065046-001 CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION 2004-01-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065046-001 CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION AP 2004-01-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065046-001 CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION AP 2004-01-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065046-001 CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION AP 2004-01-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065046-001 CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION AP 2004-01-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065046-001 CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION AP 2004-01-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065046-001 CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION AP 2004-01-09 e64feba35796…
Observed Orange Book normalized TE history# 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/8mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309101 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 0143-9976-03 Cefuroxime 10 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 10 8 0143-9976-91 Cefuroxime 82.5 mL in 1 VIAL, PHARMACY BULK PACKAGE INJECTION, POWDER, FOR SOLUTION 82.5 8
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9976 CEFUROXIME INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 8 Current NDC, Legacy NDC, 2 package rows 20220820_65daa2aa-cc4a-4eba-b7dc-7a151806865a.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 0143-9976-03 00143997603 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0143-9976-03) / 82.5 mL in 1 VIAL, PHARMACY BULK PACKAGE (0143-9976-91) 2004-01-09 0000-00-00 No No Current 0143-9976-91 00143997691 82.5 mL in 1 VIAL, PHARMACY BULK PACKAGE 82.5 ml Historical