FDA.reportPublic FDA data

Cefazolin

Product NDC
60505-6231
11-digit product format
605056231
Labeler code
60505
Product ID
60505-6231_10b501ca-c77f-4b3f-85df-ddf2715bfcd0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefazolin
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Apotex Corp.
Application
ANDA203661
Marketing category
ANDA
Marketing start
2022-03-18
Substance
CEFAZOLIN SODIUM
Active strength
2 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 SODIUM2 g/1

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
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
60505-6231-0Cefazolin1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION113
60505-6231-5Cefazolin25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION2513

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-6231-0EA - Each60505-62316533cda7-17d5-4947-93c1-05dc314ff1f212022-04-06
60505-6231-5EA - Each60505-623127e6f759-6db5-4c5d-91b1-330aed3468b712022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-6231CEFAZOLIN INJECTION, POWDER, FOR SOLUTION [APOTEX CORP.]12Current NDC, Legacy NDC, 2 package rows20240220_0422fe47-c372-494f-bac2-612f550b44a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665050ceFAZolin 1 GM InjectionPSN0422fe47-c372-494f-bac2-612f550b44a413
1665060ceFAZolin 2 GM InjectionPSN0422fe47-c372-494f-bac2-612f550b44a413
2630753ceFAZolin 3 GM InjectionPSN0422fe47-c372-494f-bac2-612f550b44a413
1665050cefazolin 1000 MG InjectionSCD0422fe47-c372-494f-bac2-612f550b44a413
1665060cefazolin 2000 MG InjectionSCD0422fe47-c372-494f-bac2-612f550b44a413
2630753cefazolin 3000 MG InjectionSCD0422fe47-c372-494f-bac2-612f550b44a413
1665060cefazolin (as cefazolin sodium) 2 GM InjectionSY0422fe47-c372-494f-bac2-612f550b44a413
2630753cefazolin (as cefazolin sodium) 3 GM InjectionSY0422fe47-c372-494f-bac2-612f550b44a413
1665050cefazolin 1 GM (as cefazolin sodium) InjectionSY0422fe47-c372-494f-bac2-612f550b44a413
1665050cefazolin 1 GM InjectionSY0422fe47-c372-494f-bac2-612f550b44a413

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-6231-0605056231001 in 1 VIAL, SINGLE-DOSEHistorical
60505-6231-56050562310525 VIAL, SINGLE-DOSE in 1 CARTON (60505-6231-5) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (60505-6231-0) 2022-03-180000-00-00NoNoCurrent