Home NDC 0143-9935 Cefotaxime
Product NDC 0143-9935
11-digit product format 001439935
Labeler code 0143
Product ID 0143-9935_e25af43f-54cb-4526-a8a5-6bef0a7939c7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefotaxime
Dosage form INJECTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA065071
Marketing category ANDA
Marketing start 2002-11-20
Substance CEFOTAXIME SODIUM
Active strength 10 g/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 43 .
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 A065071-001 CEFOTAXIME CEFOTAXIME SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20
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 · 43 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 2026-09-14 22:38:34 2026-08 A065071-001 CEFOTAXIME EQ 10GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065071-001 CEFOTAXIME EQ 10GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065071-001 CEFOTAXIME EQ 10GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065071-001 CEFOTAXIME EQ 10GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065071-001 CEFOTAXIME EQ 10GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065071-001 CEFOTAXIME EQ 10GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065071-001 CEFOTAXIME EQ 10GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065071-001 CEFOTAXIME EQ 10GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065071-001 CEFOTAXIME EQ 10GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065071-001 CEFOTAXIME EQ 10GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065071-001 CEFOTAXIME EQ 10GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065071-001 CEFOTAXIME EQ 10GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065071-001 CEFOTAXIME EQ 10GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065071-001 CEFOTAXIME EQ 10GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065071-001 CEFOTAXIME EQ 10GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065071-001 CEFOTAXIME EQ 10GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065071-001 CEFOTAXIME EQ 10GM BASE/VIAL INJECTABLE / INJECTION RS 2002-11-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065071-001 CEFOTAXIME EQ 10GM BASE/VIAL INJECTABLE / INJECTION RS 2002-11-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065071-001 CEFOTAXIME EQ 10GM BASE/VIAL INJECTABLE / INJECTION RS 2002-11-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065071-001 CEFOTAXIME EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2002-11-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065071-001 CEFOTAXIME EQ 10GM BASE/VIAL INJECTABLE / INJECTION RS 2002-11-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065071-001 CEFOTAXIME EQ 10GM BASE/VIAL INJECTABLE / INJECTION RS 2002-11-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065071-001 CEFOTAXIME EQ 10GM BASE/VIAL INJECTABLE / INJECTION RS 2002-11-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065071-001 CEFOTAXIME EQ 10GM BASE/VIAL INJECTABLE / INJECTION RS 2002-11-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065071-001 CEFOTAXIME EQ 10GM BASE/VIAL INJECTABLE / INJECTION RS 2002-11-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065071-001 CEFOTAXIME EQ 10GM BASE/VIAL INJECTABLE / INJECTION RS 2002-11-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065071-001 CEFOTAXIME EQ 10GM BASE/VIAL INJECTABLE / INJECTION RS 2002-11-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065071-001 CEFOTAXIME EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2002-11-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065071-001 CEFOTAXIME EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP RS 2002-11-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065071-001 CEFOTAXIME EQ 10GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065071-001 CEFOTAXIME EQ 10GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065071-001 CEFOTAXIME EQ 10GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065071-001 CEFOTAXIME EQ 10GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065071-001 CEFOTAXIME EQ 10GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065071-001 CEFOTAXIME EQ 10GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065071-001 CEFOTAXIME EQ 10GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065071-001 CEFOTAXIME EQ 10GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065071-001 CEFOTAXIME EQ 10GM BASE/VIAL INJECTABLE / INJECTION RS 2002-11-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065071-001 CEFOTAXIME EQ 10GM BASE/VIAL INJECTABLE / INJECTION RS 2002-11-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065071-001 CEFOTAXIME EQ 10GM BASE/VIAL INJECTABLE / INJECTION RS 2002-11-20 f41ea6bd6efb…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Cefotaxime
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEFOTAXIME SODIUM 10 g/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 258J72S7TZ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309065 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 0143-9935-01 Cefotaxime 1 in 1 PACKAGE INJECTION 1 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9935 CEFOTAXIME INJECTION [HIKMA PHARMACEUTICALS USA INC.] 9 Current NDC, Legacy NDC, 1 package rows 20240413_ef1a6dc6-bc3d-4f09-8f92-7ff328f56561.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 0143-9935-01 00143993501 1 INJECTION in 1 PACKAGE (0143-9935-01) 1 injection 2002-11-20 0000-00-00 No No Current