FDA.reportPublic FDA data

Cefazolin

Product NDC
0143-9923
11-digit product format
001439923
Labeler code
0143
Product ID
0143-9923_6cdaf80f-9ba2-4b0f-903d-61e0811ffaae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefazolin
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA065047
Marketing category
ANDA
Marketing start
2001-09-18
Substance
CEFAZOLIN SODIUM
Active strength
225 mg/mL
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFAZOLIN SODIUM225 mg/mL

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
0143-9923-90Cefazolin2.2 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION2.213

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9923-90EA - Each0143-9923adf6f918-67a5-463c-89ee-cec8f9f1c47012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFAZOLIN SODIUMACTIVE INGREDIENTP380M0454ZCEFAZOLIN INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP]5
CEFAZOLINACTIVE MOIETYIHS69L0Y4TCEFAZOLIN INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP]5
CEFAZOLIN SODIUMACTIVE INGREDIENTP380M0454ZCEFAZOLIN (CEFAZOLIN SODIUM) INJECTION [PHYSICIANS TOTAL CARE, INC.]1
CEFAZOLINACTIVE MOIETYIHS69L0Y4TCEFAZOLIN (CEFAZOLIN SODIUM) INJECTION [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9923CEFAZOLIN INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]12Current NDC, Legacy NDC, 1 package rows20240605_1dc9de56-e259-4546-a1db-23119a8a088e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665050ceFAZolin 1 GM InjectionPSN1dc9de56-e259-4546-a1db-23119a8a088e13
1665052ceFAZolin 500 MG InjectionPSN1dc9de56-e259-4546-a1db-23119a8a088e13
1665050cefazolin 1000 MG InjectionSCD1dc9de56-e259-4546-a1db-23119a8a088e13
1665052cefazolin 500 MG InjectionSCD1dc9de56-e259-4546-a1db-23119a8a088e13
1665052cefazolin (as cefazolin sodium) 500 MG InjectionSY1dc9de56-e259-4546-a1db-23119a8a088e13
1665050cefazolin 1 GM (as cefazolin sodium) InjectionSY1dc9de56-e259-4546-a1db-23119a8a088e13
1665050cefazolin 1 GM InjectionSY1dc9de56-e259-4546-a1db-23119a8a088e13
1665052ceFAZolin 500 MG InjectionPSN922fb1a1-ad4c-4a12-8d5d-00fe13af18e86
1665052cefazolin 500 MG InjectionSCD922fb1a1-ad4c-4a12-8d5d-00fe13af18e86
1665052cefazolin (as cefazolin sodium) 500 MG InjectionSY922fb1a1-ad4c-4a12-8d5d-00fe13af18e86

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9923-90001439923902.2 mL in 1 VIAL (0143-9923-90) 2.2 ml2001-09-180000-00-00NoNoCurrent