Oxaliplatin

Product NDC
79672-825
11-digit product format
796720825
Labeler code
79672
Product ID
79672-825_7c421a07-6b7a-4cff-a9dd-b7d6ca44debd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXALIPLATIN
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Nextgen Pharmaceuticals LLC
Application
ANDA204616
Marketing category
ANDA
Marketing start
2020-07-01
Marketing end
0000-00-00
Substance
OXALIPLATIN
Active strength
50 mg/10mL
Pharmacologic classes
Platinum-based Drug [EPC],Platinum-containing Compounds [EXT]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0364c41f-a4ea-b691-2739-986f76e794e5Product name920190125
b153e9b5-916b-4df6-8413-d22b82f1d312Product name220170720

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79672-825-02Oxaliplatin10 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,103
79672-825-02Oxaliplatin1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
79672-825-02EA - Each79672-8254bb3bac3-1401-47d0-9472-8f83b3db14e912021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79672-825OXALIPLATIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NEXTGEN PHARMACEUTICALS LLC]3Legacy NDC, 2 package rows20231226_95b05292-36a1-4946-b8b3-835a3a77f4a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736786oxaliplatin 100 MG InjectionPSN95b05292-36a1-4946-b8b3-835a3a77f4a73
1736784oxaliplatin 50 MG InjectionPSN95b05292-36a1-4946-b8b3-835a3a77f4a73
1736786oxaliplatin 100 MG InjectionSCD95b05292-36a1-4946-b8b3-835a3a77f4a73
1736784oxaliplatin 50 MG InjectionSCD95b05292-36a1-4946-b8b3-835a3a77f4a73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
79672-825-02796720825021 VIAL, SINGLE-USE in 1 CARTON (79672-825-02) > 10 mL in 1 VIAL, SINGLE-USE2020-07-010000-00-00NoNoCurrent