FDA.reportPublic FDA data

Cefazolin

Product NDC
60505-6244
11-digit product format
605056244
Labeler code
60505
Product ID
60505-6244_0c841753-3bec-fb8a-e063-6294a90a0d2b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefazolin
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Apotex Corp.
Application
ANDA209217
Marketing category
ANDA
Marketing start
2022-09-01
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
60505-6244-0Cefazolin1 in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, POWDER, FOR SOLUTION12
60505-6244-4Cefazolin10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-6244-0EA - Each60505-62440964bc75-39a7-4f74-a5d6-ad05e6616edc12022-12-07
60505-6244-4EA - Each60505-6244b30d7742-00b0-4931-9023-dc0018d0ceec12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-6244CEFAZOLIN INJECTION, POWDER, FOR SOLUTION [APOTEX CORP.]2Current NDC, Legacy NDC, 2 package rows20231215_0e8d4462-7642-4296-a605-6c1493e91ffd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313920ceFAZolin 200 MG/ML InjectionPSN0e8d4462-7642-4296-a605-6c1493e91ffd2
313920cefazolin 200 MG/ML Injectable SolutionSCD0e8d4462-7642-4296-a605-6c1493e91ffd2
313920cefazolin (as cefazolin sodium) 200 MG/ML Injectable SolutionSY0e8d4462-7642-4296-a605-6c1493e91ffd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-6244-0605056244001 in 1 VIAL, PHARMACY BULK PACKAGEHistorical
60505-6244-46050562440410 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (60505-6244-4) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE (60505-6244-0) 2022-09-010000-00-00NoNoCurrent