FDA.reportPublic FDA data

OSELTAMIVIR PHOSPHATE

Product NDC
53002-1387
11-digit product format
530021387
Labeler code
53002
Product ID
53002-1387_931285a2-66e6-4ad3-99ef-b0648b8086aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OSELTAMIVIR PHOSPHATE
Dosage form
CAPSULE
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA208578
Marketing category
ANDA
Marketing start
2017-02-24
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
53002-1387-12025-01-30C16284748780-19d75b9d0-bcb0-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
53002-1387-12023-06-07C16284748780-19d75b9d0-bcb0-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
53002-1387-12023-01-30C16284748780-19d75b9d0-bcb0-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
53002-1387-12020-12-15C16284748780-19d75b9d0-bcb0-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
53002-1387-12020-01-31C16284748780-19d75b9d0-bcb0-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
53002-1387-1OSELTAMIVIR PHOSPHATE1 in 1 CARTONCAPSULE18
53002-1387-1OSELTAMIVIR PHOSPHATE10 in 1 BLISTER PACKCAPSULE108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53002-1387-1EA - Each53002-13873289a125-ccd7-4984-b8e7-f2aada5d03be12018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-1387OSELTAMIVIR PHOSPHATE CAPSULE [RPK PHARMACEUTICALS, INC.]8Legacy NDC, 2 package rows20230609_82fc6ef1-cc49-4f65-a91d-04a8572689cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728113oseltamivir phosphate 45 MG Oral CapsulePSN82fc6ef1-cc49-4f65-a91d-04a8572689cb8
312122oseltamivir phosphate 75 MG Oral CapsulePSN82fc6ef1-cc49-4f65-a91d-04a8572689cb8
728113oseltamivir 45 MG Oral CapsuleSCD82fc6ef1-cc49-4f65-a91d-04a8572689cb8
312122oseltamivir 75 MG Oral CapsuleSCD82fc6ef1-cc49-4f65-a91d-04a8572689cb8
728113oseltamivir (as oseltamivir phosphate) 45 MG Oral CapsuleSY82fc6ef1-cc49-4f65-a91d-04a8572689cb8
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY82fc6ef1-cc49-4f65-a91d-04a8572689cb8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-1387-1530021387011 BLISTER PACK in 1 CARTON (53002-1387-1) > 10 CAPSULE in 1 BLISTER PACK1 blister pack2017-09-010000-00-00NoNoCurrent