FDA.reportPublic FDA data

CEFTRIAXONE

Product NDC
57297-622
11-digit product format
572970622
Labeler code
57297
Product ID
57297-622_58528d70-4576-4005-a6ac-6c7807920c7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEFTRIAXONE
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
LUPIN LIMITED
Application
ANDA065125
Marketing category
ANDA
Marketing start
2009-06-01
Marketing end
0000-00-00
Substance
CEFTRIAXONE SODIUM
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57297-622-012020-01-31C16284748780-19d75b9d0-9a21-f424-e053-dadaa90a57ceCeftriaxone for Injection USP, 250 mg, 500 mg, 1 g and 2 g
57297-622-102020-01-31C16284748780-19d75b9d0-9a21-f424-e053-dadaa90a57ceCeftriaxone for Injection USP, 250 mg, 500 mg, 1 g and 2 g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57297-622-01CEFTRIAXONE1 in 1 BOXINJECTION, POWDER, FOR SOLUTION11
57297-622-10CEFTRIAXONE10 in 1 BOXINJECTION, POWDER, FOR SOLUTION101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57297-622CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [LUPIN LIMITED]1Legacy NDC, 2 package rows20160524_bc1cc991-3e16-48a3-8912-73750674143b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665021cefTRIAXone 1 GM InjectionPSNbc1cc991-3e16-48a3-8912-73750674143b1
1665046cefTRIAXone 2 GM InjectionPSNbc1cc991-3e16-48a3-8912-73750674143b1
309092cefTRIAXone 250 MG InjectionPSNbc1cc991-3e16-48a3-8912-73750674143b1
1665005cefTRIAXone 500 MG InjectionPSNbc1cc991-3e16-48a3-8912-73750674143b1
1665021ceftriaxone 1000 MG InjectionSCDbc1cc991-3e16-48a3-8912-73750674143b1
1665046ceftriaxone 2000 MG InjectionSCDbc1cc991-3e16-48a3-8912-73750674143b1
309092ceftriaxone 250 MG InjectionSCDbc1cc991-3e16-48a3-8912-73750674143b1
1665005ceftriaxone 500 MG InjectionSCDbc1cc991-3e16-48a3-8912-73750674143b1
1665021ceftriaxone 1 GM (as ceftriaxone sodium) InjectionSYbc1cc991-3e16-48a3-8912-73750674143b1
1665046ceftriaxone 2 GM (as ceftriaxone sodium) InjectionSYbc1cc991-3e16-48a3-8912-73750674143b1
309092ceftriaxone 250 MG (as ceftriaxone sodium) InjectionSYbc1cc991-3e16-48a3-8912-73750674143b1
1665005ceftriaxone 500 MG (as ceftriaxone sodium) InjectionSYbc1cc991-3e16-48a3-8912-73750674143b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
57297-622-01572970622011 in 1 BOXHistorical
57297-622-105729706221010 in 1 BOXHistorical