FDA.reportPublic FDA data

Cefazolin

Product NDC
0338-3503
11-digit product format
003383503
Labeler code
0338
Product ID
0338-3503_9139fd65-24ba-42a9-a084-9d6dd2d1b181
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefazolin Sodium
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
NDA207131
Marketing category
NDA
Marketing start
2015-08-07
Substance
CEFAZOLIN SODIUM
Active strength
1 g/50mL
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/50mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP380M0454Z
Rxcui1665050, 1665060, 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
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
6e62eeca-6666-f31f-9873-48ea9ede8354Product name220190214
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
afa25392-d76e-4453-8841-fde3a34824f1Product name220160309
53cae805-773b-4bc5-a836-3e22e250892eProduct name120150922
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
05d4c919-c877-4ec4-cb08-9fcbbbfd8c70Product name120140508
75ba2549-0297-c880-16c8-4fa502c95a9dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0338-3503-41Cefazolin24 in 1 CARTONINJECTION, SOLUTION2417
0338-3503-41Cefazolin50 mL in 1 BAGINJECTION, SOLUTION5017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-3503-41ML - Milliliter0338-3503a6f49c5c-fe4a-49bd-9cfd-a9d233a1179a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFAZOLIN SODIUMACTIVE INGREDIENTP380M0454ZCEFAZOLIN (CEFAZOLIN SODIUM) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]2
CEFAZOLINACTIVE MOIETYIHS69L0Y4TCEFAZOLIN (CEFAZOLIN SODIUM) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]2
DEXTROSE MONOHYDRATEINACTIVE INGREDIENTLX22YL083GCEFAZOLIN (CEFAZOLIN SODIUM) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]2
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOCEFAZOLIN (CEFAZOLIN SODIUM) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]2
WATERINACTIVE INGREDIENT059QF0KO0RCEFAZOLIN (CEFAZOLIN SODIUM) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-3503CEFAZOLIN (CEFAZOLIN SODIUM) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]15Current NDC, Legacy NDC, 2 package rows20250519_d91a8d13-99a0-4d87-88dc-71cbd37922b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665050ceFAZolin 1 GM InjectionPSNd91a8d13-99a0-4d87-88dc-71cbd37922b417
1665060ceFAZolin 2 GM InjectionPSNd91a8d13-99a0-4d87-88dc-71cbd37922b417
2630753ceFAZolin 3 GM InjectionPSNd91a8d13-99a0-4d87-88dc-71cbd37922b417
1665050cefazolin 1000 MG InjectionSCDd91a8d13-99a0-4d87-88dc-71cbd37922b417
1665060cefazolin 2000 MG InjectionSCDd91a8d13-99a0-4d87-88dc-71cbd37922b417
2630753cefazolin 3000 MG InjectionSCDd91a8d13-99a0-4d87-88dc-71cbd37922b417
1665060cefazolin (as cefazolin sodium) 2 GM InjectionSYd91a8d13-99a0-4d87-88dc-71cbd37922b417
2630753cefazolin (as cefazolin sodium) 3 GM InjectionSYd91a8d13-99a0-4d87-88dc-71cbd37922b417
1665050cefazolin 1 GM (as cefazolin sodium) InjectionSYd91a8d13-99a0-4d87-88dc-71cbd37922b417
1665050cefazolin 1 GM InjectionSYd91a8d13-99a0-4d87-88dc-71cbd37922b417

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0338-3503-410033835034124 BAG in 1 CARTON (0338-3503-41) / 50 mL in 1 BAG24 bag2015-08-070000-00-00NoNoCurrent