FDA.reportPublic FDA data

Ceftriaxone Sodium

Product NDC
70518-2499
11-digit product format
705182499
Labeler code
70518
Product ID
70518-2499_4a2c61de-94ed-eb0b-e063-6294a90a0e2a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ceftriaxone Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
REMEDYREPACK INC.
Application
ANDA065169
Marketing category
ANDA
Marketing start
2019-12-19
Substance
CEFTRIAXONE SODIUM
Active strength
1 g/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 SODIUM1 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii023Z5BR09K
Rxcui1665021

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
70518-2499-02023-03-24C16284748780-1f386c649-ea13-0266-e053-dadaa90a7c1aCeftriaxone for Injection, USP
70518-2499-02023-01-30C16284748780-1f386c649-ea13-0266-e053-dadaa90a7c1aCeftriaxone for Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2499-0Ceftriaxone Sodium10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION108
70518-2499-1Ceftriaxone Sodium1 in 1 VIAL, SINGLE-USEINJECTION, POWDER, FOR SOLUTION18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2499-0EA - Each70518-249983bcfd45-82aa-444d-9bd5-534c3d65bbfb12026-01-08
70518-2499-1EA - Each70518-24996b171be5-39b7-416e-8af7-8faad0f3d0d012026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665021cefTRIAXone 1 GM InjectionPSN9c801096-ca61-4b29-a1e1-5f7e7813b1918
1665021ceftriaxone 1000 MG InjectionSCD9c801096-ca61-4b29-a1e1-5f7e7813b1918
1665021ceftriaxone 1 GM (as ceftriaxone sodium) InjectionSY9c801096-ca61-4b29-a1e1-5f7e7813b1918

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2499-07051824990010 VIAL, SINGLE-USE in 1 CARTON (70518-2499-0) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE (70518-2499-1) 2019-12-190000-00-00NoNoCurrent
70518-2499-1705182499011 in 1 VIAL, SINGLE-USEHistorical