FDA.reportPublic FDA data

Oseltamivir Phosphate

Product NDC
64380-797
11-digit product format
643800797
Labeler code
64380
Product ID
64380-797_aa0e2642-b771-4a8d-b790-cac43f40f956
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir Phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA209421
Marketing category
ANDA
Marketing start
2018-10-08
Substance
OSELTAMIVIR PHOSPHATE
Active strength
30 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 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
64380-797-01Oseltamivir Phosphate10 in 1 BLISTER PACKCAPSULE108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-797-01EA - Each64380-7971e784acf-58b6-4ab9-a8da-5e7a365d909812018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-797OSELTAMIVIR PHOSPHATE CAPSULE [STRIDES PHARMA SCIENCE LIMITED]8Current NDC, Legacy NDC, 1 package rows20221213_f26154bd-374c-44a8-983a-b2724a591653.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728109oseltamivir phosphate 30 MG Oral CapsulePSNf26154bd-374c-44a8-983a-b2724a5916538
728113oseltamivir phosphate 45 MG Oral CapsulePSNf26154bd-374c-44a8-983a-b2724a5916538
312122oseltamivir phosphate 75 MG Oral CapsulePSNf26154bd-374c-44a8-983a-b2724a5916538
728109oseltamivir 30 MG Oral CapsuleSCDf26154bd-374c-44a8-983a-b2724a5916538
728113oseltamivir 45 MG Oral CapsuleSCDf26154bd-374c-44a8-983a-b2724a5916538
312122oseltamivir 75 MG Oral CapsuleSCDf26154bd-374c-44a8-983a-b2724a5916538
728109oseltamivir (as oseltamivir phosphate) 30 MG Oral CapsuleSYf26154bd-374c-44a8-983a-b2724a5916538
728113oseltamivir (as oseltamivir phosphate) 45 MG Oral CapsuleSYf26154bd-374c-44a8-983a-b2724a5916538
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSYf26154bd-374c-44a8-983a-b2724a5916538
728109oseltamivir phosphate 30 MG Oral CapsulePSNe63b5fd6-3cef-485f-88c2-343499fe855b1
728109oseltamivir phosphate 30 MG Oral CapsulePSN92726a00-4237-49fd-9e29-5d4f5f9998741
728113oseltamivir phosphate 45 MG Oral CapsulePSN92726a00-4237-49fd-9e29-5d4f5f9998741
312122oseltamivir phosphate 75 MG Oral CapsulePSN92726a00-4237-49fd-9e29-5d4f5f9998741
728109oseltamivir 30 MG Oral CapsuleSCDe63b5fd6-3cef-485f-88c2-343499fe855b1
728109oseltamivir 30 MG Oral CapsuleSCD92726a00-4237-49fd-9e29-5d4f5f9998741
728113oseltamivir 45 MG Oral CapsuleSCD92726a00-4237-49fd-9e29-5d4f5f9998741
312122oseltamivir 75 MG Oral CapsuleSCD92726a00-4237-49fd-9e29-5d4f5f9998741
728109oseltamivir (as oseltamivir phosphate) 30 MG Oral CapsuleSY92726a00-4237-49fd-9e29-5d4f5f9998741
728109oseltamivir (as oseltamivir phosphate) 30 MG Oral CapsuleSYe63b5fd6-3cef-485f-88c2-343499fe855b1
728113oseltamivir (as oseltamivir phosphate) 45 MG Oral CapsuleSY92726a00-4237-49fd-9e29-5d4f5f9998741
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY92726a00-4237-49fd-9e29-5d4f5f9998741

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-797-016438007970110 CAPSULE in 1 BLISTER PACK (64380-797-01) 10 capsule2018-10-080000-00-00NoNoCurrent