FDA.reportPublic FDA data

Cefotaxime

Product NDC
21586-011
11-digit product format
215860011
Labeler code
21586
Product ID
21586-011_425c90b3-5006-427e-95f6-93ee7918fb8b
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
1 g/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cefotaxime
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFOTAXIME SODIUM1 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii258J72S7TZ

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
21586-011-01Cefotaxime1 in 1 VIALPOWDER, FOR SOLUTION16
21586-011-02Cefotaxime10 in 1 PACKAGEPOWDER, FOR SOLUTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21586-011-01EA - Each21586-01168a635ef-a8aa-4888-bbe0-f582204d6fdc12022-11-07
21586-011-02EA - Each21586-011605844a2-e1fc-49ab-b24f-8e5308d55fd412022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21586-011CEFOTAXIME (CEFOTAXIME INJECTION) POWDER, FOR SOLUTION [STERIMAX INC.]6Current NDC, Legacy NDC, 2 package rows20241215_8efe3bd0-c43a-2bd6-e053-2a95a90a92fa.zip

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
21586-011-01215860011011 in 1 VIALHistorical
21586-011-022158600110210 VIAL in 1 PACKAGE (21586-011-02) / 1 POWDER, FOR SOLUTION in 1 VIAL (21586-011-01) 10 vial2019-08-010000-00-00NoNoCurrent