FDA.reportPublic FDA data

Cefazolin

Product NDC
0143-9983
11-digit product format
001439983
Labeler code
0143
Product ID
0143-9983_a1fc6bdd-6f1b-402f-9e84-b6e5ed5febb4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefazolin
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA065143
Marketing category
ANDA
Marketing start
2004-10-18
Substance
CEFAZOLIN SODIUM
Active strength
10 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
Cefazolin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFAZOLIN SODIUM10 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP380M0454Z
Rxcui313920

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
0143-9983-03Cefazolin10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1015
0143-9983-91Cefazolin1 in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, POWDER, FOR SOLUTION115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9983-03EA - Each0143-99833001ae6a-f260-483d-bba1-f3c7fa7b0fdc12012-07-24
0143-9983-91EA - Each0143-998320375fd5-ad1f-4080-8395-b0b15d2faf2b12013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFAZOLIN SODIUMACTIVE INGREDIENTP380M0454ZCEFAZOLIN INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP]12
CEFAZOLINACTIVE MOIETYIHS69L0Y4TCEFAZOLIN INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9983CEFAZOLIN INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]15Current NDC, Legacy NDC, 2 package rows20240420_06091653-e568-4e82-acc7-aefbce16de17.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313920ceFAZolin 200 MG/ML InjectionPSN06091653-e568-4e82-acc7-aefbce16de1715
313920cefazolin 200 MG/ML Injectable SolutionSCD06091653-e568-4e82-acc7-aefbce16de1715
313920cefazolin (as cefazolin sodium) 200 MG/ML Injectable SolutionSY06091653-e568-4e82-acc7-aefbce16de1715

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0143-9983-030014399830310 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0143-9983-03) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE (0143-9983-91) 2004-10-180000-00-00NoNoCurrent
0143-9983-91001439983911 in 1 VIAL, PHARMACY BULK PACKAGEHistorical