FDA.reportPublic FDA data

Cefazolin

Product NDC
44567-708
11-digit product format
445670708
Labeler code
44567
Product ID
44567-708_d94c6e64-269c-4cbb-b5e5-77a338d8c7f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefazolin
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
WG Critical Care, LLC
Application
ANDA065306
Marketing category
ANDA
Marketing start
2015-03-06
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
44567-708-10Cefazolin1 in 1 VIALINJECTION, POWDER, FOR SOLUTION110
44567-708-10Cefazolin10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44567-708-10EA - Each44567-70819437ac2-c3af-402d-b2a9-b639e76f600a12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFAZOLIN SODIUMACTIVE INGREDIENTP380M0454ZCEFAZOLIN INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]6
CEFAZOLINACTIVE MOIETYIHS69L0Y4TCEFAZOLIN INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44567-708CEFAZOLIN INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]10Current NDC, Legacy NDC, 2 package rows20211003_1999084a-124c-45f9-801f-416a1b942c96.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313920ceFAZolin 200 MG/ML InjectionPSN1999084a-124c-45f9-801f-416a1b942c9610
313920cefazolin 200 MG/ML Injectable SolutionSCD1999084a-124c-45f9-801f-416a1b942c9610
313920cefazolin (as cefazolin sodium) 200 MG/ML Injectable SolutionSY1999084a-124c-45f9-801f-416a1b942c9610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44567-708-104456707081010 VIAL in 1 CARTON (44567-708-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL10 vial2015-03-060000-00-00NoNoCurrent