FDA.reportPublic FDA data

Ceftriaxone Sodium

Product NDC
0409-7336
11-digit product format
004097336
Labeler code
0409
Product ID
0409-7336_8e4ee031-a0df-403f-8a7e-de9626a7e501
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ceftriaxone Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc
Application
ANDA065204
Marketing category
ANDA
Marketing start
2005-07-20
Marketing end
2027-04-30
Substance
CEFTRIAXONE SODIUM
Active strength
2 g/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ceftriaxone Sodium

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFTRIAXONE SODIUM2 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
0409-7336-04Ceftriaxone Sodium10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1021
0409-7336-11Ceftriaxone Sodium1 in 1 VIAL, SINGLE-USEINJECTION, POWDER, FOR SOLUTION121
0409-7336-49Ceftriaxone Sodium1 in 1 VIAL, SINGLE-USEINJECTION, POWDER, FOR SOLUTION120
0409-7336-49Ceftriaxone Sodium10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-7336-04EA - Each0409-7336cd778995-0272-4ad6-9c34-0212f6cfb61812012-07-24
0409-7336-11EA - Each0409-73364ce55e99-af3d-42f9-bedd-a7b7f986d9fd12019-03-12
0409-7336-49EA - Each0409-7336ad1c6311-8cc9-4d25-96e7-e7bfd5f5fc0f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFTRIAXONE SODIUMACTIVE INGREDIENT023Z5BR09KCEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION [HOSPIRA, INC]16
CEFTRIAXONE SODIUMACTIVE INGREDIENT023Z5BR09KCEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION [HOSPIRA, INC]16
CEFTRIAXONEACTIVE MOIETY75J73V1629CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION [HOSPIRA, INC]16
CEFTRIAXONEACTIVE MOIETY75J73V1629CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION [HOSPIRA, INC]16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-7336CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION [HOSPIRA, INC]20Current NDC, Legacy NDC, 2 package rows20240113_128bb292-d174-4769-b3e6-9f16617f31e3.zip
0409-7336CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION [HOSPIRA, INC]20Current NDC, Legacy NDC, 2 package rows20241225_9d1f630b-e759-4395-9d01-ddc90e4fea75.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665021cefTRIAXone 1 GM InjectionPSN128bb292-d174-4769-b3e6-9f16617f31e321
1665046cefTRIAXone 2 GM InjectionPSN128bb292-d174-4769-b3e6-9f16617f31e321
1665021ceftriaxone 1000 MG InjectionSCD128bb292-d174-4769-b3e6-9f16617f31e321
1665046ceftriaxone 2000 MG InjectionSCD128bb292-d174-4769-b3e6-9f16617f31e321
1665021ceftriaxone 1 GM (as ceftriaxone sodium) InjectionSY128bb292-d174-4769-b3e6-9f16617f31e321
1665046ceftriaxone 2 GM (as ceftriaxone sodium) InjectionSY128bb292-d174-4769-b3e6-9f16617f31e321
1665021cefTRIAXone 1 GM InjectionPSN9d1f630b-e759-4395-9d01-ddc90e4fea7520
1665046cefTRIAXone 2 GM InjectionPSN9d1f630b-e759-4395-9d01-ddc90e4fea7520
1665021ceftriaxone 1000 MG InjectionSCD9d1f630b-e759-4395-9d01-ddc90e4fea7520
1665046ceftriaxone 2000 MG InjectionSCD9d1f630b-e759-4395-9d01-ddc90e4fea7520
1665021ceftriaxone 1 GM (as ceftriaxone sodium) InjectionSY9d1f630b-e759-4395-9d01-ddc90e4fea7520
1665046ceftriaxone 2 GM (as ceftriaxone sodium) InjectionSY9d1f630b-e759-4395-9d01-ddc90e4fea7520

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0409-7336-040040973360410 VIAL, SINGLE-USE in 1 CARTON (0409-7336-04) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE (0409-7336-11) 2005-07-202027-04-30NoNoCurrent
0409-7336-11004097336111 in 1 VIAL, SINGLE-USEHistorical
0409-7336-49004097336491 in 1 VIAL, SINGLE-USEHistorical