FDA.reportPublic FDA data

Ceftriaxone

Product NDC
70594-095
11-digit product format
705940095
Labeler code
70594
Product ID
70594-095_b414c892-8c86-4df5-8085-737897006085
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ceftriaxone
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Xellia Pharmaceuticals USA LLC
Application
ANDA091049
Marketing category
ANDA
Marketing start
2022-01-06
Marketing end
0000-00-00
Substance
CEFTRIAXONE SODIUM
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
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
70594-095-022024-07-30C16284748780-11030e365-1b01-111a-e063-dadaa90a10e2CEFTRIAXONE FOR INJECTION, USP (For Intravenous or Intramuscular Use)
70594-095-022024-01-30C16284748780-11030e365-1b01-111a-e063-dadaa90a10e2CEFTRIAXONE FOR INJECTION, USP (For Intravenous or Intramuscular Use)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70594-095-01Ceftriaxone1 in 1 VIALINJECTION, POWDER, FOR SOLUTION11
70594-095-02Ceftriaxone25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION251

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70594-095-01EA - Each70594-0952ee58540-aba8-41af-bded-b07082b456ad12022-08-04
70594-095-02EA - Each70594-09565775a29-67f4-4be6-8e07-d8c01cd499e912022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70594-095CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION [XELLIA PHARMACEUTICALS USA LLC]1Legacy NDC, 2 package rows20220430_2b662308-1d22-4f44-9d4f-088db5883212.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665021cefTRIAXone 1 GM InjectionPSN2b662308-1d22-4f44-9d4f-088db58832121
1665046cefTRIAXone 2 GM InjectionPSN2b662308-1d22-4f44-9d4f-088db58832121
309092cefTRIAXone 250 MG InjectionPSN2b662308-1d22-4f44-9d4f-088db58832121
1665005cefTRIAXone 500 MG InjectionPSN2b662308-1d22-4f44-9d4f-088db58832121
1665021ceftriaxone 1000 MG InjectionSCD2b662308-1d22-4f44-9d4f-088db58832121
1665046ceftriaxone 2000 MG InjectionSCD2b662308-1d22-4f44-9d4f-088db58832121
309092ceftriaxone 250 MG InjectionSCD2b662308-1d22-4f44-9d4f-088db58832121
1665005ceftriaxone 500 MG InjectionSCD2b662308-1d22-4f44-9d4f-088db58832121
1665021ceftriaxone 1 GM (as ceftriaxone sodium) InjectionSY2b662308-1d22-4f44-9d4f-088db58832121
1665046ceftriaxone 2 GM (as ceftriaxone sodium) InjectionSY2b662308-1d22-4f44-9d4f-088db58832121
309092ceftriaxone 250 MG (as ceftriaxone sodium) InjectionSY2b662308-1d22-4f44-9d4f-088db58832121
1665005ceftriaxone 500 MG (as ceftriaxone sodium) InjectionSY2b662308-1d22-4f44-9d4f-088db58832121

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70594-095-01705940095011 in 1 VIALHistorical
70594-095-027059400950225 VIAL in 1 CARTON (70594-095-02) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70594-095-01) 25 vial2022-01-060000-00-00NoNoCurrent