FDA.reportPublic FDA data

Oseltamivir phosphate

Product NDC
53002-3710
11-digit product format
530023710
Labeler code
53002
Product ID
53002-3710_5cfcf41c-7fe1-45d1-8b0f-fcb5173374ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA208348
Marketing category
ANDA
Marketing start
2018-02-09
Marketing end
0000-00-00
Substance
OSELTAMIVIR PHOSPHATE
Active strength
45 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-3710-12025-01-30C16284748780-1f386c649-d13e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use OSELTAMIVIR PHOSPHATE CAPSULES safely and effectively. See full prescribing information for OSELTAMIVIR PHOSPHATE CAPSULES. OSELTAMIVIR PHOSPHATE capsules, for oral use Initial U.S. Approval: 1999
53002-3710-12023-06-08C16284748780-1f386c649-d13e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use OSELTAMIVIR PHOSPHATE CAPSULES safely and effectively. See full prescribing information for OSELTAMIVIR PHOSPHATE CAPSULES. OSELTAMIVIR PHOSPHATE capsules, for oral use Initial U.S. Approval: 1999
53002-3710-12023-01-30C16284748780-1f386c649-d13e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use OSELTAMIVIR PHOSPHATE CAPSULES safely and effectively. See full prescribing information for OSELTAMIVIR PHOSPHATE CAPSULES. OSELTAMIVIR PHOSPHATE capsules, for oral use Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-3710-1Oseltamivir phosphate10 in 1 BLISTER PACKCAPSULE103
53002-3710-1Oseltamivir phosphate1 in 1 CARTONCAPSULE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-3710OSELTAMIVIR PHOSPHATE CAPSULE [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 2 package rows20230609_e33583ad-90b9-4b61-9888-a974cbd5ede8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728113oseltamivir phosphate 45 MG Oral CapsulePSNe33583ad-90b9-4b61-9888-a974cbd5ede83
728113oseltamivir 45 MG Oral CapsuleSCDe33583ad-90b9-4b61-9888-a974cbd5ede83
728113oseltamivir (as oseltamivir phosphate) 45 MG Oral CapsuleSYe33583ad-90b9-4b61-9888-a974cbd5ede83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-3710-1530023710011 BLISTER PACK in 1 CARTON (53002-3710-1) > 10 CAPSULE in 1 BLISTER PACK1 blister pack2020-01-010000-00-00NoNoCurrent