FDA.reportPublic FDA data

Ceftriaxone Sodium

Product NDC
67184-1005
11-digit product format
671841005
Labeler code
67184
Product ID
67184-1005_49f990ff-ec42-da5c-e063-6294a90aee7d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ceftriaxone Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Qilu Pharmaceutical Co., Ltd.
Application
ANDA203702
Marketing category
ANDA
Marketing start
2016-06-29
Substance
CEFTRIAXONE SODIUM
Active strength
250 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ceftriaxone Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFTRIAXONE SODIUM250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii023Z5BR09K
Rxcui309092, 1665005, 1665021, 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
67184-1005-1Ceftriaxone Sodium10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION104
67184-1005-1Ceftriaxone Sodium1 in 1 VIAL, SINGLE-USEINJECTION, POWDER, FOR SOLUTION14
67184-1005-2Ceftriaxone Sodium1 in 1 VIAL, SINGLE-USEINJECTION, POWDER, FOR SOLUTION14
67184-1005-2Ceftriaxone Sodium1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67184-1005CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION [QILU PHARMACEUTICAL CO., LTD.]2Current NDC, Legacy NDC, 4 package rows20181121_4cdf0743-c62b-4969-b9c9-4c6400644f6c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665021cefTRIAXone 1 GM InjectionPSN4cdf0743-c62b-4969-b9c9-4c6400644f6c4
1665046cefTRIAXone 2 GM InjectionPSN4cdf0743-c62b-4969-b9c9-4c6400644f6c4
309092cefTRIAXone 250 MG InjectionPSN4cdf0743-c62b-4969-b9c9-4c6400644f6c4
1665005cefTRIAXone 500 MG InjectionPSN4cdf0743-c62b-4969-b9c9-4c6400644f6c4
1665021ceftriaxone 1000 MG InjectionSCD4cdf0743-c62b-4969-b9c9-4c6400644f6c4
1665046ceftriaxone 2000 MG InjectionSCD4cdf0743-c62b-4969-b9c9-4c6400644f6c4
309092ceftriaxone 250 MG InjectionSCD4cdf0743-c62b-4969-b9c9-4c6400644f6c4
1665005ceftriaxone 500 MG InjectionSCD4cdf0743-c62b-4969-b9c9-4c6400644f6c4
1665021ceftriaxone 1 GM (as ceftriaxone sodium) InjectionSY4cdf0743-c62b-4969-b9c9-4c6400644f6c4
1665046ceftriaxone 2 GM (as ceftriaxone sodium) InjectionSY4cdf0743-c62b-4969-b9c9-4c6400644f6c4
309092ceftriaxone 250 MG (as ceftriaxone sodium) InjectionSY4cdf0743-c62b-4969-b9c9-4c6400644f6c4
1665005ceftriaxone 500 MG (as ceftriaxone sodium) InjectionSY4cdf0743-c62b-4969-b9c9-4c6400644f6c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67184-1005-16718410050110 VIAL, SINGLE-USE in 1 CARTON (67184-1005-1) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE2016-06-290000-00-00NoNoCurrent
67184-1005-2671841005021 VIAL, SINGLE-USE in 1 CARTON (67184-1005-2) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE2016-06-290000-00-00NoNoCurrent