FDA.reportPublic FDA data

CEFAZOLIN

Product NDC
63323-237
11-digit product format
633230237
Labeler code
63323
Product ID
63323-237_321ffc80-ee94-4a86-8c33-e966438d9fbb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEFAZOLIN SODIUM
Dosage form
POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA065303
Marketing category
ANDA
Marketing start
2011-07-15
Substance
CEFAZOLIN SODIUM
Active strength
1 g/3mL
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
CEFAZOLIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFAZOLIN SODIUM1 g/3mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP380M0454Z
Rxcui1665050, 1665052

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4c53c44d-0495-40c1-9f02-9d772dc7a5c7Product name120250318
53d47d5d-6076-4275-8f76-06d261cff1e8Product name120231011
9afe2d9a-f7f6-416b-9ddf-b780a2810bd5Product name120230912
6e62eeca-6666-f31f-9873-48ea9ede8354Product name220190214
afa25392-d76e-4453-8841-fde3a34824f1Product name220160309
53cae805-773b-4bc5-a836-3e22e250892eProduct name120150922
05d4c919-c877-4ec4-cb08-9fcbbbfd8c70Product name120140508
75ba2549-0297-c880-16c8-4fa502c95a9dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-237-01CEFAZOLIN3 mL in 1 VIALPOWDER, FOR SOLUTION38
63323-237-10CEFAZOLIN25 in 1 CARTONPOWDER, FOR SOLUTION258

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-237-10EA - Each63323-2378ca6489e-d684-4f7b-a91f-23ede5a7fb1d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFAZOLIN SODIUMACTIVE INGREDIENTP380M0454ZCEFAZOLIN (CEFAZOLIN SODIUM) POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]3
CEFAZOLINACTIVE MOIETYIHS69L0Y4TCEFAZOLIN (CEFAZOLIN SODIUM) POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-237CEFAZOLIN (CEFAZOLIN SODIUM) POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]8Current NDC, Legacy NDC, 2 package rows20231019_c47c8d14-1eef-40f9-9d11-f0c300b1d4be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665050ceFAZolin 1 GM InjectionPSNc47c8d14-1eef-40f9-9d11-f0c300b1d4be8
1665052ceFAZolin 500 MG InjectionPSNc47c8d14-1eef-40f9-9d11-f0c300b1d4be8
1665050cefazolin 1000 MG InjectionSCDc47c8d14-1eef-40f9-9d11-f0c300b1d4be8
1665052cefazolin 500 MG InjectionSCDc47c8d14-1eef-40f9-9d11-f0c300b1d4be8
1665052cefazolin (as cefazolin sodium) 500 MG InjectionSYc47c8d14-1eef-40f9-9d11-f0c300b1d4be8
1665050cefazolin 1 GM (as cefazolin sodium) InjectionSYc47c8d14-1eef-40f9-9d11-f0c300b1d4be8
1665050cefazolin 1 GM InjectionSYc47c8d14-1eef-40f9-9d11-f0c300b1d4be8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-237-01633230237013 mL in 1 VIAL3 mlHistorical
63323-237-106332302371025 VIAL in 1 CARTON (63323-237-10) / 3 mL in 1 VIAL (63323-237-01) 25 vial2011-07-150000-00-00NoNoCurrent