FDA.reportPublic FDA data

Oxaliplatin

Product NDC
47335-046
11-digit product format
473350046
Labeler code
47335
Product ID
47335-046_7920a0b4-15a0-4f07-8254-4a9d8e33e43d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxaliplatin
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA202922
Marketing category
ANDA
Marketing start
2014-04-09
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
47335-046-402020-01-31C16284748780-19d75b9d0-bcc2-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use OXALIPLATIN INJECTION safely and effectively. See full prescribing information for OXALIPLATIN INJECTION. OXALIPLATIN injection, for intravenous use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47335-046-40Oxaliplatin1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE112
47335-046-40Oxaliplatin10 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION, CONCENTRATE1012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-046-40ML - Milliliter47335-046142be3be-33f7-4400-b19c-5813b15360a512014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXALIPLATINACTIVE INGREDIENT04ZR38536JOXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [SUN PHARMA GLOBAL FZE]8
OXALIPLATINACTIVE MOIETY04ZR38536JOXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [SUN PHARMA GLOBAL FZE]8
WATERINACTIVE INGREDIENT059QF0KO0ROXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [SUN PHARMA GLOBAL FZE]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-046OXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [SUN PHARMACEUTICAL INDUSTRIES, INC.]12Legacy NDC, 2 package rows20181031_20910750-2bb6-4258-8368-df9ec207bfdd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736781oxaliplatin 100 MG in 20 ML InjectionPSN20910750-2bb6-4258-8368-df9ec207bfdd12
1736776oxaliplatin 50 MG in 10 ML InjectionPSN20910750-2bb6-4258-8368-df9ec207bfdd12
173677610 ML oxaliplatin 5 MG/ML InjectionSCD20910750-2bb6-4258-8368-df9ec207bfdd12
173678120 ML oxaliplatin 5 MG/ML InjectionSCD20910750-2bb6-4258-8368-df9ec207bfdd12
1736781oxaliplatin 100 MG per 20 ML InjectionSY20910750-2bb6-4258-8368-df9ec207bfdd12
1736776oxaliplatin 50 MG per 10 ML InjectionSY20910750-2bb6-4258-8368-df9ec207bfdd12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
47335-046-40473350046401 in 1 CARTONHistorical