FDA.reportPublic FDA data

Oseltamivir phosphate

Product NDC
69539-110
11-digit product format
695390110
Labeler code
69539
Product ID
69539-110_1eceb65e-b7b6-42ff-9fb7-2d47a6e978c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
MSN LABORATORIES PRIVATE LIMITED
Application
ANDA212544
Marketing category
ANDA
Marketing start
2020-05-22
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
69539-110-11Oseltamivir phosphate10 in 1 BLISTER PACKCAPSULE106
69539-110-33Oseltamivir phosphate1 in 1 CARTONCAPSULE16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69539-110OSELTAMIVIR PHOSPHATE CAPSULE [MSN LABORATORIES PRIVATE LIMITED]5Current NDC, Legacy NDC, 2 package rows20221204_1b7a02ca-ee0e-4853-91e6-71a79f2bc040.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728109oseltamivir phosphate 30 MG Oral CapsulePSN1b7a02ca-ee0e-4853-91e6-71a79f2bc0406
728113oseltamivir phosphate 45 MG Oral CapsulePSN1b7a02ca-ee0e-4853-91e6-71a79f2bc0406
312122oseltamivir phosphate 75 MG Oral CapsulePSN1b7a02ca-ee0e-4853-91e6-71a79f2bc0406
728109oseltamivir 30 MG Oral CapsuleSCD1b7a02ca-ee0e-4853-91e6-71a79f2bc0406
728113oseltamivir 45 MG Oral CapsuleSCD1b7a02ca-ee0e-4853-91e6-71a79f2bc0406
312122oseltamivir 75 MG Oral CapsuleSCD1b7a02ca-ee0e-4853-91e6-71a79f2bc0406
728109oseltamivir (as oseltamivir phosphate) 30 MG Oral CapsuleSY1b7a02ca-ee0e-4853-91e6-71a79f2bc0406
728113oseltamivir (as oseltamivir phosphate) 45 MG Oral CapsuleSY1b7a02ca-ee0e-4853-91e6-71a79f2bc0406
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY1b7a02ca-ee0e-4853-91e6-71a79f2bc0406

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69539-110-116953901101110 in 1 BLISTER PACKHistorical
69539-110-33695390110331 BLISTER PACK in 1 CARTON (69539-110-33) > 10 CAPSULE in 1 BLISTER PACK (69539-110-11) 1 blister pack2020-05-220000-00-00NoNoCurrent