Oseltamivir Phosphate

Product NDC
53002-5387
11-digit product format
530025387
Labeler code
53002
Product ID
53002-5387_42e50056-05a9-46a5-9537-e0ec3354f42f
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
75 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
53002-5387-1Oseltamivir Phosphate10 in 1 BLISTER PACKCAPSULE101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-5387OSELTAMIVIR PHOSPHATE CAPSULE [RPK PHARMACEUTICALS, INC.]1Legacy NDC, 1 package rows20220420_9aa12239-dbf3-4655-a1c4-e9cad4876c18.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312122oseltamivir phosphate 75 MG Oral CapsulePSN9aa12239-dbf3-4655-a1c4-e9cad4876c181
312122oseltamivir 75 MG Oral CapsuleSCD9aa12239-dbf3-4655-a1c4-e9cad4876c181
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY9aa12239-dbf3-4655-a1c4-e9cad4876c181

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-5387-15300253870110 CAPSULE in 1 BLISTER PACK (53002-5387-1) 10 capsule2021-01-010000-00-00NoNoCurrent