FDA.reportPublic FDA data

Oseltamivir Phosphate

Product NDC
53217-280
11-digit product format
532170280
Labeler code
53217
Product ID
53217-280_b71630b8-6cea-458d-9d81-bc8bd7fcb092
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA202595
Marketing category
ANDA
Marketing start
2016-12-12
Marketing end
0000-00-00
Substance
OSELTAMIVIR PHOSPHATE
Active strength
75 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
c6022fcc-885e-41f7-971c-fe19ade5d9baProduct name920190926

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53217-280-012020-01-31C16284748780-19d75b9d0-297a-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 USP, for oral use Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-280-01Oseltamivir Phosphate10 in 1 BLISTER PACKCAPSULE101
53217-280-01Oseltamivir Phosphate1 in 1 CARTONCAPSULE11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-280-01EA - Each53217-280e64a20e2-ba4d-4474-a786-3dab619e913012017-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-280OSELTAMIVIR PHOSPHATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 2 package rows20170422_394365f1-056d-437c-b46b-dd907a67a9cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312122oseltamivir phosphate 75 MG Oral CapsulePSN394365f1-056d-437c-b46b-dd907a67a9cb1
312122oseltamivir 75 MG Oral CapsuleSCD394365f1-056d-437c-b46b-dd907a67a9cb1
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY394365f1-056d-437c-b46b-dd907a67a9cb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-280-015321702800110 in 1 BLISTER PACKHistorical