CEFOTAXIME

Product NDC
55648-986
11-digit product format
556480986
Labeler code
55648
Product ID
55648-986_ae6f86a8-6a5c-4c3a-a8cb-aee20b427b5b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEFOTAXIME
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
WOCKHARDT LIMITED
Application
ANDA065197
Marketing category
ANDA
Marketing start
2006-08-29
Marketing end
0000-00-00
Substance
CEFOTAXIME SODIUM
Active strength
1 g/mL
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55648-986IInactivated by FDA2026-10-05
excluded packagepackage55648-98655648-986-02IInactivated by FDA2026-10-05
excluded packagepackage55648-98655648-986-03IInactivated by FDA2026-10-05
excluded packagepackage55648-98655648-986-04IInactivated by FDA2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 88 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-986-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-986-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-986-03d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-986-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-986-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-986-03f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-986-042ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-986-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-986-032ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-986-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-986-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-986-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-986-04cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-986-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-986-03cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-986-04cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-986-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-986-03cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-986-04302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-986-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-986-03302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55648-986-04ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55648-986-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55648-986-03ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55648-986-040efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55648-986-020efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55648-986-030efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55648-986-04ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55648-986-02ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55648-986-03ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55648-986-04367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55648-986-02367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55648-986-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55648-986-04557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55648-986-02557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55648-986-03557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage55648-986-048af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage55648-986-028af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage55648-986-038af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage55648-986-04834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage55648-986-02834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage55648-986-03834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage55648-986-041332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage55648-986-021332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage55648-986-031332a3947898…d4bfe170f9cd…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065197-001CEFOTAXIMECEFOTAXIME SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTION2006-08-29
A065197-002CEFOTAXIME SODIUMCEFOTAXIME SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2008-06-20
A065197-003CEFOTAXIME SODIUMCEFOTAXIME SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2008-06-20

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A065197-001CEFOTAXIMEEQ 1GM BASE/VIALINJECTABLE / INJECTION2006-08-2984e616aacf4f…
2026-09-14 22:38:342026-08A065197-002CEFOTAXIME SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2008-06-2084e616aacf4f…
2026-09-14 22:38:342026-08A065197-003CEFOTAXIME SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2008-06-2084e616aacf4f…
2026-08-18 06:07:402026-07A065197-001CEFOTAXIMEEQ 1GM BASE/VIALINJECTABLE / INJECTION2006-08-29caaa826d4ba7…
2026-08-18 06:07:402026-07A065197-002CEFOTAXIME SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2008-06-20caaa826d4ba7…
2026-08-18 06:07:402026-07A065197-003CEFOTAXIME SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2008-06-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065197-001CEFOTAXIMEEQ 1GM BASE/VIALINJECTABLE / INJECTION2006-08-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065197-002CEFOTAXIME SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2008-06-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065197-003CEFOTAXIME SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2008-06-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065197-001CEFOTAXIMEEQ 1GM BASE/VIALINJECTABLE / INJECTION2006-08-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065197-002CEFOTAXIME SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2008-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065197-003CEFOTAXIME SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2008-06-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A065197-001CEFOTAXIMEEQ 1GM BASE/VIALINJECTABLE / INJECTION2006-08-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065197-002CEFOTAXIME SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2008-06-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065197-003CEFOTAXIME SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2008-06-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065197-001CEFOTAXIMEEQ 1GM BASE/VIALINJECTABLE / INJECTION2006-08-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065197-002CEFOTAXIME SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2008-06-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065197-003CEFOTAXIME SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2008-06-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065197-001CEFOTAXIMEEQ 1GM BASE/VIALINJECTABLE / INJECTION2006-08-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065197-002CEFOTAXIME SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2008-06-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065197-003CEFOTAXIME SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2008-06-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065197-001CEFOTAXIMEEQ 1GM BASE/VIALINJECTABLE / INJECTION2006-08-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065197-002CEFOTAXIME SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2008-06-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065197-003CEFOTAXIME SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2008-06-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065197-001CEFOTAXIMEEQ 1GM BASE/VIALINJECTABLE / INJECTION2006-08-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065197-002CEFOTAXIME SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2008-06-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065197-003CEFOTAXIME SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2008-06-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065197-001CEFOTAXIMEEQ 1GM BASE/VIALINJECTABLE / INJECTION2006-08-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065197-002CEFOTAXIME SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2008-06-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065197-003CEFOTAXIME SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2008-06-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065197-001CEFOTAXIMEEQ 1GM BASE/VIALINJECTABLE / INJECTION2006-08-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065197-002CEFOTAXIME SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2008-06-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065197-003CEFOTAXIME SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2008-06-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065197-001CEFOTAXIMEEQ 1GM BASE/VIALINJECTABLE / INJECTION2006-08-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A065197-002CEFOTAXIME SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2008-06-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A065197-003CEFOTAXIME SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2008-06-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065197-001CEFOTAXIMEEQ 1GM BASE/VIALINJECTABLE / INJECTION2006-08-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065197-002CEFOTAXIME SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTION2008-06-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065197-003CEFOTAXIME SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2008-06-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065197-001CEFOTAXIMEEQ 1GM BASE/VIALINJECTABLE / INJECTION2006-08-29301d65b070ca…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A065197-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065197-002AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065197-003AP174a2ff9319b5…
2019-09-15 20:21 UTC2019-09A065197-001AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09A065197-002AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09A065197-003AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065197-001AP1ea99ee380514…
2019-07-19 19:46 UTC2019-07A065197-002AP1ea99ee380514…
2019-07-19 19:46 UTC2019-07A065197-003AP1ea99ee380514…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
240c5dde-7ad4-44da-afce-de9486640146Product name220160328

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-986-01CEFOTAXIME1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION11
55648-986-01CEFOTAXIME10 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION101
55648-986-02CEFOTAXIME10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION101
55648-986-03CEFOTAXIME25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION251
55648-986-04CEFOTAXIME50 in 1 CARTONINJECTION, POWDER, FOR SOLUTION501

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFOTAXIME SODIUMACTIVE INGREDIENT258J72S7TZCEFOTAXIME INJECTION, POWDER, FOR SOLUTION [WOCKHARDT LIMITED]1
CEFOTAXIMEACTIVE MOIETYN2GI8B1GK7CEFOTAXIME INJECTION, POWDER, FOR SOLUTION [WOCKHARDT LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-986CEFOTAXIME INJECTION, POWDER, FOR SOLUTION [WOCKHARDT LIMITED]1Legacy NDC, 5 package rows20101026_a401a44e-2c5c-4c4a-81d8-56a3ef9d57f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1656313cefotaxime 1 GM InjectionPSNa401a44e-2c5c-4c4a-81d8-56a3ef9d57f71
1656318cefotaxime 2 GM InjectionPSNa401a44e-2c5c-4c4a-81d8-56a3ef9d57f71
309068cefotaxime 500 MG InjectionPSNa401a44e-2c5c-4c4a-81d8-56a3ef9d57f71
1656313cefotaxime 1000 MG InjectionSCDa401a44e-2c5c-4c4a-81d8-56a3ef9d57f71
1656318cefotaxime 2000 MG InjectionSCDa401a44e-2c5c-4c4a-81d8-56a3ef9d57f71
309068cefotaxime 500 MG InjectionSCDa401a44e-2c5c-4c4a-81d8-56a3ef9d57f71
1656313cefotaxime (as cefotaxime sodium) 1 GM InjectionSYa401a44e-2c5c-4c4a-81d8-56a3ef9d57f71
1656318cefotaxime (as cefotaxime sodium) 2 GM InjectionSYa401a44e-2c5c-4c4a-81d8-56a3ef9d57f71
309068cefotaxime (as cefotaxime sodium) 500 MG InjectionSYa401a44e-2c5c-4c4a-81d8-56a3ef9d57f71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-986-01556480986011 in 1 CARTONHistorical
55648-986-025564809860210 in 1 CARTONHistorical
55648-986-035564809860325 in 1 CARTONHistorical
55648-986-045564809860450 in 1 CARTONHistorical