FDA.reportPublic FDA data

Oseltamivir Phosphate

Product NDC
69238-1266
11-digit product format
692381266
Labeler code
69238
Product ID
69238-1266_1a821b0c-d9cd-4915-8b49-4b60bddfbe43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA209093
Marketing category
ANDA
Marketing start
2017-05-21
Substance
OSELTAMIVIR PHOSPHATE
Active strength
75 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 PHOSPHATE75 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
69238-1266-1Oseltamivir Phosphate10 in 1 BLISTER PACKCAPSULE1022
69238-1266-1Oseltamivir Phosphate1 in 1 CARTONCAPSULE122

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1266-1EA - Each69238-126639bc3954-9424-4d34-966d-e2149438609612017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1266OSELTAMIVIR PHOSPHATE (OSELTAMIVIR) CAPSULE [AMNEAL PHARMACEUTICALS NY LLC]22Current NDC, Legacy NDC, 2 package rows20231231_d306e22c-0cb8-46cb-9a40-8194a2bc9e85.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728109oseltamivir phosphate 30 MG Oral CapsulePSNd306e22c-0cb8-46cb-9a40-8194a2bc9e8522
728113oseltamivir phosphate 45 MG Oral CapsulePSNd306e22c-0cb8-46cb-9a40-8194a2bc9e8522
312122oseltamivir phosphate 75 MG Oral CapsulePSNd306e22c-0cb8-46cb-9a40-8194a2bc9e8522
728109oseltamivir 30 MG Oral CapsuleSCDd306e22c-0cb8-46cb-9a40-8194a2bc9e8522
728113oseltamivir 45 MG Oral CapsuleSCDd306e22c-0cb8-46cb-9a40-8194a2bc9e8522
312122oseltamivir 75 MG Oral CapsuleSCDd306e22c-0cb8-46cb-9a40-8194a2bc9e8522
728109oseltamivir (as oseltamivir phosphate) 30 MG Oral CapsuleSYd306e22c-0cb8-46cb-9a40-8194a2bc9e8522
728113oseltamivir (as oseltamivir phosphate) 45 MG Oral CapsuleSYd306e22c-0cb8-46cb-9a40-8194a2bc9e8522
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSYd306e22c-0cb8-46cb-9a40-8194a2bc9e8522
312122oseltamivir phosphate 75 MG Oral CapsulePSN5445db5c-d262-45f4-9979-b1edcda08d5a5
312122oseltamivir 75 MG Oral CapsuleSCD5445db5c-d262-45f4-9979-b1edcda08d5a5
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY5445db5c-d262-45f4-9979-b1edcda08d5a5
312122oseltamivir phosphate 75 MG Oral CapsulePSN1fc21a67-c618-af75-e063-6394a90ae1e81
312122oseltamivir 75 MG Oral CapsuleSCD1fc21a67-c618-af75-e063-6394a90ae1e81
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY1fc21a67-c618-af75-e063-6394a90ae1e81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1266-1692381266011 BLISTER PACK in 1 CARTON (69238-1266-1) / 10 CAPSULE in 1 BLISTER PACK1 blister pack2017-05-210000-00-00NoNoCurrent