Home NDC 0143-9933 Cefotaxime
Product NDC 0143-9933
11-digit product format 001439933
Labeler code 0143
Product ID 0143-9933_7e0897ec-2275-4438-9cc5-4c951e52ad97
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefotaxime
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA065072
Marketing category ANDA
Marketing start 2002-11-20
Substance CEFOTAXIME SODIUM
Active strength 2 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065072-001 CEFOTAXIME CEFOTAXIME SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2002-11-20 A065072-002 CEFOTAXIME CEFOTAXIME SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 A065072-003 CEFOTAXIME CEFOTAXIME SODIUM EQ 2GM 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 4 · 129 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 A065072-001 CEFOTAXIME EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2002-11-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065072-002 CEFOTAXIME EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065072-003 CEFOTAXIME EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065072-001 CEFOTAXIME EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2002-11-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065072-002 CEFOTAXIME EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065072-003 CEFOTAXIME EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065072-001 CEFOTAXIME EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2002-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065072-002 CEFOTAXIME EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065072-003 CEFOTAXIME EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065072-001 CEFOTAXIME EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2002-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065072-002 CEFOTAXIME EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065072-003 CEFOTAXIME EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065072-001 CEFOTAXIME EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2002-11-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065072-002 CEFOTAXIME EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065072-003 CEFOTAXIME EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065072-001 CEFOTAXIME EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2002-11-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065072-002 CEFOTAXIME EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065072-003 CEFOTAXIME EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065072-001 CEFOTAXIME EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2002-11-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065072-002 CEFOTAXIME EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065072-003 CEFOTAXIME EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065072-001 CEFOTAXIME EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2002-11-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065072-002 CEFOTAXIME EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065072-003 CEFOTAXIME EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065072-001 CEFOTAXIME EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2002-11-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065072-002 CEFOTAXIME EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065072-003 CEFOTAXIME EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065072-001 CEFOTAXIME EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2002-11-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065072-002 CEFOTAXIME EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065072-003 CEFOTAXIME EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065072-001 CEFOTAXIME EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2002-11-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065072-002 CEFOTAXIME EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065072-003 CEFOTAXIME EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065072-001 CEFOTAXIME EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2002-11-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065072-002 CEFOTAXIME EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065072-003 CEFOTAXIME EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065072-001 CEFOTAXIME EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2002-11-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065072-002 CEFOTAXIME EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065072-003 CEFOTAXIME EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2002-11-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065072-001 CEFOTAXIME EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2002-11-20 301d65b070ca…
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 2 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309068 Internal RxNorm lookup 1656313 Internal RxNorm lookup 1656318 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 0143-9933-01 Cefotaxime 1 in 1 VIAL INJECTION, POWDER, FOR SOLUTION 1 14 0143-9933-25 Cefotaxime 25 in 1 PACKAGE INJECTION, POWDER, FOR SOLUTION 25 14
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9933 CEFOTAXIME INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 14 Current NDC, Legacy NDC, 2 package rows 20240413_ed23b6bc-32c7-4c50-a53d-313ae78e5623.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 0143-9933-01 00143993301 1 in 1 VIAL Historical 0143-9933-25 00143993325 25 VIAL in 1 PACKAGE (0143-9933-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9933-01) 25 vial 2002-11-20 0000-00-00 No No Current