Cefotaxime

Product NDC
21586-012
Requested package NDC
21586-012-02
11-digit product format
215860012
Labeler code
21586
Product ID
21586-012_7a77a18a-3d8c-4bac-8d21-54a88db396f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cefotaxime injection
Dosage form
POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
SteriMax Inc.
Marketing category
UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
Marketing start
2019-08-01
Substance
CEFOTAXIME SODIUM
Active strength
2 g/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFOTAXIME SODIUM2 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
258J72S7TZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1656313Internal RxNorm lookup
1656318Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8efe3bd0-c43a-2bd6-e053-2a95a90a92faAvailable on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21586-012-01Cefotaxime1 in 1 VIALPOWDER, FOR SOLUTION16
21586-012-02Cefotaxime10 in 1 PACKAGEPOWDER, FOR SOLUTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21586-012-01EA - Each21586-0123bc41caa-c2d4-43c1-8fac-77750c71950f12022-11-07
21586-012-02EA - Each21586-0127108843f-bd85-4ac3-ae34-351e1bcebe4112022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21586-012CEFOTAXIME (CEFOTAXIME INJECTION) POWDER, FOR SOLUTION [STERIMAX INC.]6Current NDC, Legacy NDC, 2 package rows20241215_8efe3bd0-c43a-2bd6-e053-2a95a90a92fa.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CefotaximeCEFOTAXIME INJECTIONSteriMax Inc.8efe3bd0-c43a-2bd6-e053-2a95a90a92fa2026-06-15Exact identifier
ndc (package): 21586-012-02
ndc (product): 21586-012
ndc11 (package): 21586001202

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1656313cefotaxime 1 GM InjectionPSN8efe3bd0-c43a-2bd6-e053-2a95a90a92fa6
1656318cefotaxime 2 GM InjectionPSN8efe3bd0-c43a-2bd6-e053-2a95a90a92fa6
1656313cefotaxime 1000 MG InjectionSCD8efe3bd0-c43a-2bd6-e053-2a95a90a92fa6
1656318cefotaxime 2000 MG InjectionSCD8efe3bd0-c43a-2bd6-e053-2a95a90a92fa6
1656313cefotaxime (as cefotaxime sodium) 1 GM InjectionSY8efe3bd0-c43a-2bd6-e053-2a95a90a92fa6
1656318cefotaxime (as cefotaxime sodium) 2 GM InjectionSY8efe3bd0-c43a-2bd6-e053-2a95a90a92fa6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21586-012-022158600120210 VIAL in 1 PACKAGE (21586-012-02) / 1 POWDER, FOR SOLUTION in 1 VIAL (21586-012-01) 10 vial2019-08-010000-00-00NoNoCurrent