FDA.reportPublic FDA data

Cefazolin

Product NDC
44567-845
11-digit product format
445670845
Labeler code
44567
Product ID
44567-845_976b22d4-f147-4281-a1af-d87835a9c356
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefazolin
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
WG Critical Care, LLC
Application
NDA211413
Marketing category
NDA
Marketing start
2024-05-10
Substance
CEFAZOLIN SODIUM
Active strength
3 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 SODIUM3 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP380M0454Z
Rxcui1665060, 2630753

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
44567-845-01Cefazolin1 in 1 VIALINJECTION, POWDER, FOR SOLUTION16
44567-845-25Cefazolin25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION256

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44567-845-01EA - Each44567-84563dc84a9-8f68-41e1-96ca-540dc01091f912024-08-12
44567-845-25EA - Each44567-845623f78c2-2e8c-42a4-aad5-6153d3096fcf12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44567-845CEFAZOLIN INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]4Current NDC, 2 package rows20250508_4f3a9248-a354-4c77-bf5b-9eed38f00219.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665060ceFAZolin 2 GM InjectionPSN4f3a9248-a354-4c77-bf5b-9eed38f002196
2630753ceFAZolin 3 GM InjectionPSN4f3a9248-a354-4c77-bf5b-9eed38f002196
1665060cefazolin 2000 MG InjectionSCD4f3a9248-a354-4c77-bf5b-9eed38f002196
2630753cefazolin 3000 MG InjectionSCD4f3a9248-a354-4c77-bf5b-9eed38f002196
1665060cefazolin (as cefazolin sodium) 2 GM InjectionSY4f3a9248-a354-4c77-bf5b-9eed38f002196
2630753cefazolin (as cefazolin sodium) 3 GM InjectionSY4f3a9248-a354-4c77-bf5b-9eed38f002196

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
44567-845-01445670845011 in 1 VIALHistorical
44567-845-254456708452525 VIAL in 1 CARTON (44567-845-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (44567-845-01) 25 vial2024-05-10NoNoHistorical