FDA.reportPublic FDA data

CEFAZOLIN

Product NDC
0404-9833
11-digit product format
004049833
Labeler code
0404
Product ID
0404-9833_b7d89e4d-5b66-41d1-9a36-10c57cf0a5b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cefazolin
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Henry Schein, Inc.
Application
ANDA203661
Marketing category
ANDA
Marketing start
2022-01-09
Substance
CEFAZOLIN SODIUM
Active strength
1 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 SODIUM1 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP380M0454Z
Rxcui1665050

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
0404-9833-99CEFAZOLIN1 in 1 BAGINJECTION, POWDER, FOR SOLUTION19
0404-9833-99CEFAZOLIN1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-9833CEFAZOLIN INJECTION, POWDER, FOR SOLUTION [HENRY SCHEIN, INC.]8Current NDC, Legacy NDC, 2 package rows20240724_5a8c4bb2-a75e-4d7d-91fb-9a95f04fc94b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665050ceFAZolin 1 GM InjectionPSN5a8c4bb2-a75e-4d7d-91fb-9a95f04fc94b9
1665050cefazolin 1000 MG InjectionSCD5a8c4bb2-a75e-4d7d-91fb-9a95f04fc94b9
1665050cefazolin 1 GM (as cefazolin sodium) InjectionSY5a8c4bb2-a75e-4d7d-91fb-9a95f04fc94b9
1665050cefazolin 1 GM InjectionSY5a8c4bb2-a75e-4d7d-91fb-9a95f04fc94b9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0404-9833-99004049833991 VIAL, SINGLE-DOSE in 1 BAG (0404-9833-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE2022-01-090000-00-00NoNoCurrent