FDA.reportPublic FDA data

OSELTAMIVIR PHOSPHATE

Product NDC
42806-554
11-digit product format
428060554
Labeler code
42806
Product ID
42806-554_6cafa8bf-ca67-4fcf-9da1-e417e7c242c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OSELTAMIVIR PHOSPHATE
Dosage form
CAPSULE
Route
ORAL
Labeler
EPIC PHARMA, LLC
Application
ANDA215208
Marketing category
ANDA
Marketing start
2021-10-01
Substance
OSELTAMIVIR PHOSPHATE
Active strength
45 mg/1
Pharmacologic classes
Neuraminidase Inhibitor [EPC], Neuraminidase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
OSELTAMIVIR PHOSPHATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OSELTAMIVIR PHOSPHATE45 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4A3O49NGEZ
Rxcui312122, 728109, 728113

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
c6022fcc-885e-41f7-971c-fe19ade5d9baProduct name920190926

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42806-554-01OSELTAMIVIR PHOSPHATE100 in 1 BOTTLECAPSULE1004
42806-554-11OSELTAMIVIR PHOSPHATE10 in 1 BOTTLECAPSULE104
42806-554-80OSELTAMIVIR PHOSPHATE10 in 1 BLISTER PACKCAPSULE104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-554OSELTAMIVIR PHOSPHATE CAPSULE [EPIC PHARMA, LLC]4Current NDC, 3 package rows20240919_141c4005-89de-447e-961f-3780f62eded4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728109oseltamivir phosphate 30 MG Oral CapsulePSN141c4005-89de-447e-961f-3780f62eded44
728113oseltamivir phosphate 45 MG Oral CapsulePSN141c4005-89de-447e-961f-3780f62eded44
312122oseltamivir phosphate 75 MG Oral CapsulePSN141c4005-89de-447e-961f-3780f62eded44
728109oseltamivir 30 MG Oral CapsuleSCD141c4005-89de-447e-961f-3780f62eded44
728113oseltamivir 45 MG Oral CapsuleSCD141c4005-89de-447e-961f-3780f62eded44
312122oseltamivir 75 MG Oral CapsuleSCD141c4005-89de-447e-961f-3780f62eded44
728109oseltamivir (as oseltamivir phosphate) 30 MG Oral CapsuleSY141c4005-89de-447e-961f-3780f62eded44
728113oseltamivir (as oseltamivir phosphate) 45 MG Oral CapsuleSY141c4005-89de-447e-961f-3780f62eded44
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY141c4005-89de-447e-961f-3780f62eded44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42806-554-0142806055401100 CAPSULE in 1 BOTTLE (42806-554-01) 100 capsule2023-12-04NoNoCurrent
42806-554-114280605541110 CAPSULE in 1 BOTTLE (42806-554-11) 10 capsule2023-12-04NoNoCurrent
42806-554-804280605548010 CAPSULE in 1 BLISTER PACK (42806-554-80) 10 capsule2021-10-01NoNoCurrent