FDA.reportPublic FDA data

Oxaliplatin

Product NDC
47335-176
11-digit product format
473350176
Labeler code
47335
Product ID
47335-176_47ebaf59-b7c2-4f6b-bf3e-292da264662c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxaliplatin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA078818
Marketing category
ANDA
Marketing start
2009-08-19
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
2019-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
47335-176-402020-01-31C16284748780-19d75b9d0-e854-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use oxaliplatin for injection safely and effectively. See full prescribing information for oxaliplatin for injection. OXALIPLATIN for Injection, USP for intravenous use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47335-176-40Oxaliplatin10 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,107
47335-176-40Oxaliplatin1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-176-40EA - Each47335-176c175f29e-3428-4f01-b653-8a0ec3db0e5312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXALIPLATINACTIVE INGREDIENT04ZR38536JOXALIPLATIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMA GLOBAL FZE]5
OXALIPLATINACTIVE MOIETY04ZR38536JOXALIPLATIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMA GLOBAL FZE]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOXALIPLATIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMA GLOBAL FZE]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-176OXALIPLATIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]7Legacy NDC, 2 package rows20181025_8efb4c07-455b-4c91-b257-6fd43854454c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736786oxaliplatin 100 MG InjectionPSN8efb4c07-455b-4c91-b257-6fd43854454c7
1736784oxaliplatin 50 MG InjectionPSN8efb4c07-455b-4c91-b257-6fd43854454c7
1736786oxaliplatin 100 MG InjectionSCD8efb4c07-455b-4c91-b257-6fd43854454c7
1736784oxaliplatin 50 MG InjectionSCD8efb4c07-455b-4c91-b257-6fd43854454c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
47335-176-404733501764010 mL in 1 VIAL, SINGLE-USE10 mlHistorical