FDA.reportPublic FDA data

Cefotetan

Product NDC
63323-385
11-digit product format
633230385
Labeler code
63323
Product ID
63323-385_a30c7fcf-f9c0-4b38-bfed-fbd3b1a3e2f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEFOTETAN DISODIUM
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA065374
Marketing category
ANDA
Marketing start
2009-11-18
Substance
CEFOTETAN DISODIUM
Active strength
1 g/10mL
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
Cefotetan
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFOTETAN DISODIUM1 g/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0GXP746VXB
Rxcui1722919, 1722921

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0cc1eec0-2b75-6316-520b-142bcbbb9bb7Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-385-01Cefotetan10 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION109
63323-385-10Cefotetan10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-385-01EA - Each63323-3850b911497-6dc4-43e9-a30b-b148cceebdf312024-04-05
63323-385-10EA - Each63323-3855b0a02de-e9b4-4aac-b328-a9239bea1e5012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFOTETAN DISODIUMACTIVE INGREDIENT0GXP746VXBCEFOTETAN (CEFOTETAN DISODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]4
CEFOTETANACTIVE MOIETY48SPP0PA9QCEFOTETAN (CEFOTETAN DISODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-385CEFOTETAN (CEFOTETAN DISODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]9Current NDC, Legacy NDC, 2 package rows20250116_bd22c66b-8a1c-44c8-b5b6-3ab0ce5c800e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1722919cefoTEtan 1 GM InjectionPSNbd22c66b-8a1c-44c8-b5b6-3ab0ce5c800e9
1722921cefoTEtan 2 GM InjectionPSNbd22c66b-8a1c-44c8-b5b6-3ab0ce5c800e9
1722919cefotetan 1000 MG InjectionSCDbd22c66b-8a1c-44c8-b5b6-3ab0ce5c800e9
1722921cefotetan 2000 MG InjectionSCDbd22c66b-8a1c-44c8-b5b6-3ab0ce5c800e9
1722919cefotetan (as disodium) 1 GM InjectionSYbd22c66b-8a1c-44c8-b5b6-3ab0ce5c800e9
1722921cefotetan (as disodium) 2 GM InjectionSYbd22c66b-8a1c-44c8-b5b6-3ab0ce5c800e9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-385-016332303850110 mL in 1 VIAL10 mlHistorical
63323-385-106332303851010 VIAL in 1 CARTON (63323-385-10) / 10 mL in 1 VIAL (63323-385-01) 10 vial2009-11-180000-00-00NoNoCurrent