FDA.reportPublic FDA data

oseltamavir phosphate

Product NDC
53002-3387
11-digit product format
530023387
Labeler code
53002
Product ID
53002-3387_4c85da2d-993e-4a4e-8dc5-d8f554b478e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oseltamavir phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA207211
Marketing category
ANDA
Marketing start
2017-09-21
Marketing end
0000-00-00
Substance
OSELTAMIVIR PHOSPHATE
Active strength
75 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
53002-3387-12025-01-30C16284748780-19d75b9d0-0cd0-f424-e053-dadaa90a57ceThese 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
53002-3387-12023-06-07C16284748780-19d75b9d0-0cd0-f424-e053-dadaa90a57ceThese 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
53002-3387-12023-01-30C16284748780-19d75b9d0-0cd0-f424-e053-dadaa90a57ceThese 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
53002-3387-12020-12-15C16284748780-19d75b9d0-0cd0-f424-e053-dadaa90a57ceThese 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
53002-3387-12020-01-31C16284748780-19d75b9d0-0cd0-f424-e053-dadaa90a57ceThese 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
53002-3387-1oseltamavir phosphate10 in 1 BLISTER PACKCAPSULE105
53002-3387-1oseltamavir phosphate1 in 1 CARTONCAPSULE15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-3387OSELTAMAVIR PHOSPHATE CAPSULE [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 2 package rows20230609_5bb70d91-1beb-4183-902e-bdcf907be5c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312122oseltamivir phosphate 75 MG Oral CapsulePSN5bb70d91-1beb-4183-902e-bdcf907be5c35
312122oseltamivir 75 MG Oral CapsuleSCD5bb70d91-1beb-4183-902e-bdcf907be5c35
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY5bb70d91-1beb-4183-902e-bdcf907be5c35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-3387-1530023387011 BLISTER PACK in 1 CARTON (53002-3387-1) > 10 CAPSULE in 1 BLISTER PACK1 blister pack2018-10-010000-00-00NoNoCurrent