FDA.reportPublic FDA data

Cefazolin

Product NDC
0781-3451
11-digit product format
007813451
Labeler code
0781
Product ID
0781-3451_05cd44b2-275f-44f5-b4f8-22393df834a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefazolin
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; PARENTERAL
Labeler
Sandoz Inc
Application
ANDA062831
Marketing category
ANDA
Marketing start
1988-12-09
Substance
CEFAZOLIN SODIUM
Active strength
1 g/1
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 SODIUM1 g/1

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
0781-3451-70Cefazolin1 in 1 VIALINJECTION, POWDER, FOR SOLUTION119
0781-3451-95Cefazolin10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1019
0781-3451-96Cefazolin25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION2519

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3451-70EA - Each0781-3451fd19e2c6-ac4c-4b95-820c-cf6729e1e1c412012-07-24
0781-3451-95EA - Each0781-34519a4d0156-0c96-43d9-b915-ce95df0c599412026-03-17
0781-3451-96EA - Each0781-34512f8aed59-d555-4962-985f-e2441005291f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFAZOLIN SODIUMACTIVE INGREDIENTP380M0454ZCEFAZOLIN INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]12
CEFAZOLINACTIVE MOIETYIHS69L0Y4TCEFAZOLIN INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3451CEFAZOLIN INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]18Current NDC, Legacy NDC, 3 package rows20241218_18e7366a-1b3e-4010-8f4a-dd559d4f2146.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665050ceFAZolin 1 GM InjectionPSN18e7366a-1b3e-4010-8f4a-dd559d4f214619
1665052ceFAZolin 500 MG InjectionPSN18e7366a-1b3e-4010-8f4a-dd559d4f214619
1665050cefazolin 1000 MG InjectionSCD18e7366a-1b3e-4010-8f4a-dd559d4f214619
1665052cefazolin 500 MG InjectionSCD18e7366a-1b3e-4010-8f4a-dd559d4f214619
1665052cefazolin (as cefazolin sodium) 500 MG InjectionSY18e7366a-1b3e-4010-8f4a-dd559d4f214619
1665050cefazolin 1 GM (as cefazolin sodium) InjectionSY18e7366a-1b3e-4010-8f4a-dd559d4f214619
1665050cefazolin 1 GM InjectionSY18e7366a-1b3e-4010-8f4a-dd559d4f214619

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-3451-70007813451701 in 1 VIALHistorical
0781-3451-950078134519510 VIAL in 1 CARTON (0781-3451-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-3451-70) 10 vial2026-01-05NoNoHistorical
0781-3451-960078134519625 VIAL in 1 CARTON (0781-3451-96) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-3451-70) 25 vial1988-12-090000-00-00NoNoCurrent