FDA.reportPublic FDA data

Oseltamivir Phosphate

Product NDC
60219-1264
11-digit product format
602191264
Labeler code
60219
Product ID
60219-1264_140eca94-b0b9-491c-afa2-c4325b580972
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA209093
Marketing category
ANDA
Marketing start
2022-09-27
Substance
OSELTAMIVIR PHOSPHATE
Active strength
30 mg/1
Pharmacologic classes
Neuraminidase Inhibitor [EPC], Neuraminidase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Oseltamivir Phosphate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OSELTAMIVIR PHOSPHATE30 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
60219-1264-1Oseltamivir Phosphate10 in 1 BLISTER PACKCAPSULE106
60219-1264-1Oseltamivir Phosphate1 in 1 CARTONCAPSULE16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60219-1264-1EA - Each60219-12644cccebcf-0c5f-4045-8da1-a327338e29ea12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60219-1264OSELTAMIVIR PHOSPHATE (OSELTAMIVIR) CAPSULE [AMNEAL PHARMACEUTICALS NY LLC]4Current NDC, Legacy NDC, 2 package rows20250427_8ca926e0-4c3c-473f-9cd0-ff38032d6963.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728109oseltamivir phosphate 30 MG Oral CapsulePSN8ca926e0-4c3c-473f-9cd0-ff38032d69636
728113oseltamivir phosphate 45 MG Oral CapsulePSN8ca926e0-4c3c-473f-9cd0-ff38032d69636
312122oseltamivir phosphate 75 MG Oral CapsulePSN8ca926e0-4c3c-473f-9cd0-ff38032d69636
728109oseltamivir 30 MG Oral CapsuleSCD8ca926e0-4c3c-473f-9cd0-ff38032d69636
728113oseltamivir 45 MG Oral CapsuleSCD8ca926e0-4c3c-473f-9cd0-ff38032d69636
312122oseltamivir 75 MG Oral CapsuleSCD8ca926e0-4c3c-473f-9cd0-ff38032d69636
728109oseltamivir (as oseltamivir phosphate) 30 MG Oral CapsuleSY8ca926e0-4c3c-473f-9cd0-ff38032d69636
728113oseltamivir (as oseltamivir phosphate) 45 MG Oral CapsuleSY8ca926e0-4c3c-473f-9cd0-ff38032d69636
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY8ca926e0-4c3c-473f-9cd0-ff38032d69636

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60219-1264-1602191264011 BLISTER PACK in 1 CARTON (60219-1264-1) / 10 CAPSULE in 1 BLISTER PACK1 blister pack2022-09-270000-00-00NoNoCurrent