Oxaliplatin

Product NDC
57277-002
11-digit product format
572770002
Labeler code
57277
Product ID
57277-002_b33ce586-7fb1-444d-a222-7fcddd33d9d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxaliplatin
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sanja Pharmaceuticals Company
Application
ANDA205529
Marketing category
ANDA
Marketing start
2017-09-21
Marketing end
0000-00-00
Substance
OXALIPLATIN
Active strength
5 mg/mL
Pharmacologic classes
Platinum-based Drug [EPC],Platinum-containing Compounds [EXT]
NDC exclude flag
E
Listing certified through
2018-12-31
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
57277-002-10Oxaliplatin1 in 1 CARTONINJECTION, SOLUTION12
57277-002-10Oxaliplatin20 mL in 1 VIALINJECTION, SOLUTION202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57277-002OXALIPLATIN INJECTION, SOLUTION [SANJA PHARMACEUTICALS COMPANY]2Legacy NDC, 2 package rows20170921_3c853336-2533-48ff-8b02-1bdbe196ed6b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736786oxaliplatin 100 MG InjectionPSN3c853336-2533-48ff-8b02-1bdbe196ed6b2
1736784oxaliplatin 50 MG InjectionPSN3c853336-2533-48ff-8b02-1bdbe196ed6b2
1736786oxaliplatin 100 MG InjectionSCD3c853336-2533-48ff-8b02-1bdbe196ed6b2
1736784oxaliplatin 50 MG InjectionSCD3c853336-2533-48ff-8b02-1bdbe196ed6b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
57277-002-10572770002101 in 1 CARTONHistorical