FDA.reportPublic FDA data

Cefazolin

Product NDC
72572-056
11-digit product format
725720056
Labeler code
72572
Product ID
72572-056_d7b6aa18-1b83-48d3-b52e-b753f1793778
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefazolin
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Civica, Inc.
Application
ANDA065143
Marketing category
ANDA
Marketing start
2022-03-01
Substance
CEFAZOLIN SODIUM
Active strength
10 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 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
72572-056-01Cefazolin1 in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, POWDER, FOR SOLUTION12
72572-056-10Cefazolin10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72572-056-01EA - Each72572-056db2382ef-0bf8-4761-904f-34ee895d6c0c12022-08-04
72572-056-10EA - Each72572-056c02fae4a-f391-4839-a0c1-5c097cc795cb12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72572-056CEFAZOLIN INJECTION, POWDER, FOR SOLUTION [CIVICA, INC.]1Current NDC, Legacy NDC, 2 package rows20220305_c24e604f-16ca-4945-8e9d-277cc67a8c68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313920ceFAZolin 200 MG/ML InjectionPSNc24e604f-16ca-4945-8e9d-277cc67a8c682
313920cefazolin 200 MG/ML Injectable SolutionSCDc24e604f-16ca-4945-8e9d-277cc67a8c682
313920cefazolin (as cefazolin sodium) 200 MG/ML Injectable SolutionSYc24e604f-16ca-4945-8e9d-277cc67a8c682

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72572-056-01725720056011 in 1 VIAL, PHARMACY BULK PACKAGEHistorical
72572-056-107257200561010 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (72572-056-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE (72572-056-01) 2022-03-010000-00-00NoNoCurrent