Oseltamivir Phosphate

Product NDC
53002-4710
11-digit product format
530024710
Labeler code
53002
Product ID
53002-4710_d20d698c-cf89-4f40-854b-e6beeae37bd9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir Phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA209421
Marketing category
ANDA
Marketing start
2018-10-05
Marketing end
0000-00-00
Substance
OSELTAMIVIR PHOSPHATE
Active strength
45 mg/1
Pharmacologic classes
Neuraminidase Inhibitor [EPC], Neuraminidase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6022fcc-885e-41f7-971c-fe19ade5d9baProduct name920190926

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-4710-1Oseltamivir Phosphate10 in 1 BLISTER PACKCAPSULE101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-4710OSELTAMIVIR PHOSPHATE CAPSULE [RPK PHARMACEUTICALS, INC.]1Legacy NDC, 1 package rows20220421_50f4ad66-0ca6-4003-ab6e-3a521cf36b3f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728113oseltamivir phosphate 45 MG Oral CapsulePSN50f4ad66-0ca6-4003-ab6e-3a521cf36b3f1
728113oseltamivir 45 MG Oral CapsuleSCD50f4ad66-0ca6-4003-ab6e-3a521cf36b3f1
728113oseltamivir (as oseltamivir phosphate) 45 MG Oral CapsuleSY50f4ad66-0ca6-4003-ab6e-3a521cf36b3f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-4710-15300247100110 CAPSULE in 1 BLISTER PACK (53002-4710-1) 10 capsule2022-10-010000-00-00NoNoCurrent