FDA.reportPublic FDA data

Oseltamivir Phosphate

Product NDC
47781-469
11-digit product format
477810469
Labeler code
47781
Product ID
47781-469_babb1e9d-f00c-aced-9553-047624d2b26a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
Alvogen Inc.
Application
ANDA202595
Marketing category
ANDA
Marketing start
2016-12-12
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
c6022fcc-885e-41f7-971c-fe19ade5d9baProduct name920190926

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47781-469-13Oseltamivir Phosphate10 in 1 BLISTER PACKCAPSULE1020
47781-469-13Oseltamivir Phosphate1 in 1 CARTONCAPSULE120

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-469-13EA - Each47781-4692ed10158-ff43-4dd5-b406-609c84d1861a12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47781-469OSELTAMIVIR PHOSPHATE CAPSULE [ALVOGEN INC.]19Current NDC, Legacy NDC, 2 package rows20241121_809f859e-0852-80d3-1a67-da87ed399c15.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728109oseltamivir phosphate 30 MG Oral CapsulePSN809f859e-0852-80d3-1a67-da87ed399c1520
728113oseltamivir phosphate 45 MG Oral CapsulePSN809f859e-0852-80d3-1a67-da87ed399c1520
312122oseltamivir phosphate 75 MG Oral CapsulePSN809f859e-0852-80d3-1a67-da87ed399c1520
728109oseltamivir 30 MG Oral CapsuleSCD809f859e-0852-80d3-1a67-da87ed399c1520
728113oseltamivir 45 MG Oral CapsuleSCD809f859e-0852-80d3-1a67-da87ed399c1520
312122oseltamivir 75 MG Oral CapsuleSCD809f859e-0852-80d3-1a67-da87ed399c1520
728109oseltamivir (as oseltamivir phosphate) 30 MG Oral CapsuleSY809f859e-0852-80d3-1a67-da87ed399c1520
728113oseltamivir (as oseltamivir phosphate) 45 MG Oral CapsuleSY809f859e-0852-80d3-1a67-da87ed399c1520
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY809f859e-0852-80d3-1a67-da87ed399c1520

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47781-469-13477810469131 BLISTER PACK in 1 CARTON (47781-469-13) / 10 CAPSULE in 1 BLISTER PACK1 blister pack2016-12-120000-00-00NoNoCurrent