FDA.reportPublic FDA data

Ceftriaxone

Product NDC
72572-061
11-digit product format
725720061
Labeler code
72572
Product ID
72572-061_36b74132-c90c-4cda-bd0c-93855b45e205
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ceftriaxone
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Civica, Inc.
Application
ANDA065342
Marketing category
ANDA
Marketing start
2020-03-01
Substance
CEFTRIAXONE 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
Ceftriaxone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFTRIAXONE SODIUM1 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii023Z5BR09K
Rxcui1665021, 1665046

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
67ae10d0-6c6a-4d52-a629-da83321859b9Product name320190201
01b0d089-049b-4c6d-8dfe-1bffad9be307Product name220180807
2d5083fe-71de-4fce-8d67-e9049cba775cProduct name120150107
1037f4ca-3bea-c9c4-2af4-fa6387b0e81eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72572-061-01Ceftriaxone1 in 1 VIALINJECTION, POWDER, FOR SOLUTION15
72572-061-25Ceftriaxone25 in 1 BOXINJECTION, POWDER, FOR SOLUTION255

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72572-061-01EA - Each72572-06139bf9ddc-01b6-4afa-956e-34378de25f2e12020-04-20
72572-061-25EA - Each72572-0613c5d6a03-ad28-4af6-b07a-af5a51d575ba12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72572-061CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [CIVICA, INC.]5Current NDC, Legacy NDC, 2 package rows20240207_96f3fc1e-84f4-4e9b-91ac-19a1692f227a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665021cefTRIAXone 1 GM InjectionPSN96f3fc1e-84f4-4e9b-91ac-19a1692f227a5
1665046cefTRIAXone 2 GM InjectionPSN96f3fc1e-84f4-4e9b-91ac-19a1692f227a5
1665021ceftriaxone 1000 MG InjectionSCD96f3fc1e-84f4-4e9b-91ac-19a1692f227a5
1665046ceftriaxone 2000 MG InjectionSCD96f3fc1e-84f4-4e9b-91ac-19a1692f227a5
1665021ceftriaxone 1 GM (as ceftriaxone sodium) InjectionSY96f3fc1e-84f4-4e9b-91ac-19a1692f227a5
1665046ceftriaxone 2 GM (as ceftriaxone sodium) InjectionSY96f3fc1e-84f4-4e9b-91ac-19a1692f227a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72572-061-01725720061011 in 1 VIALHistorical
72572-061-257257200612525 VIAL in 1 BOX (72572-061-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72572-061-01) 25 vial2020-03-010000-00-00NoNoCurrent