FDA.reportPublic FDA data

Ceftriaxone

Product NDC
68330-005
11-digit product format
683300005
Labeler code
68330
Product ID
68330-005_4e15b344-d5b4-415b-8ce1-a856dc37a13c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ceftriaxone
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Cephazone Pharma LLC
Application
ANDA065294
Marketing category
ANDA
Marketing start
2008-07-15
Marketing end
0000-00-00
Substance
CEFTRIAXONE SODIUM
Active strength
1 g/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
68330-005-102019-11-13C16284748780-197449f38-ce81-f6ea-e053-dbdaa90aa703CEFTRIAXONE FOR INJECTION, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68330-005-01Ceftriaxone1 in 1 BOXINJECTION, POWDER, FOR SOLUTION12
68330-005-01Ceftriaxone1 in 1 VIAL, PIGGYBACKINJECTION, POWDER, FOR SOLUTION12
68330-005-10Ceftriaxone10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68330-005-01EA - Each68330-00599fc54a3-135e-4d03-b2a6-ae2f155313f012013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFTRIAXONE SODIUMACTIVE INGREDIENT023Z5BR09KCEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [CEPHAZONE PHARMA LLC]2
CEFTRIAXONEACTIVE MOIETY75J73V1629CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [CEPHAZONE PHARMA LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68330-005CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [CEPHAZONE PHARMA LLC]2Legacy NDC, 3 package rows20120908_e6ac87e3-481e-4884-ac06-1fd7279cad62.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665021cefTRIAXone 1 GM InjectionPSNe6ac87e3-481e-4884-ac06-1fd7279cad622
1665046cefTRIAXone 2 GM InjectionPSNe6ac87e3-481e-4884-ac06-1fd7279cad622
309092cefTRIAXone 250 MG InjectionPSNe6ac87e3-481e-4884-ac06-1fd7279cad622
1665005cefTRIAXone 500 MG InjectionPSNe6ac87e3-481e-4884-ac06-1fd7279cad622
1665021ceftriaxone 1000 MG InjectionSCDe6ac87e3-481e-4884-ac06-1fd7279cad622
1665046ceftriaxone 2000 MG InjectionSCDe6ac87e3-481e-4884-ac06-1fd7279cad622
309092ceftriaxone 250 MG InjectionSCDe6ac87e3-481e-4884-ac06-1fd7279cad622
1665005ceftriaxone 500 MG InjectionSCDe6ac87e3-481e-4884-ac06-1fd7279cad622
1665021ceftriaxone 1 GM (as ceftriaxone sodium) InjectionSYe6ac87e3-481e-4884-ac06-1fd7279cad622
1665046ceftriaxone 2 GM (as ceftriaxone sodium) InjectionSYe6ac87e3-481e-4884-ac06-1fd7279cad622
309092ceftriaxone 250 MG (as ceftriaxone sodium) InjectionSYe6ac87e3-481e-4884-ac06-1fd7279cad622
1665005ceftriaxone 500 MG (as ceftriaxone sodium) InjectionSYe6ac87e3-481e-4884-ac06-1fd7279cad622

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68330-005-01683300005011 in 1 BOXHistorical
68330-005-106833000051010 in 1 CARTONHistorical