OSELTAMIVIR PHOSPHATE

Product NDC
76282-704
11-digit product format
762820704
Labeler code
76282
Product ID
76282-704_89fabbee-3f3a-4ca4-b53e-4a7eb354c333
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OSELTAMIVIR PHOSPHATE
Dosage form
CAPSULE
Route
ORAL
Labeler
Exelan Pharmaceuticals, Inc.
Application
ANDA217467
Marketing category
ANDA
Marketing start
2023-12-01
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76282-704-45OSELTAMIVIR PHOSPHATE10 in 1 BLISTER PACKCAPSULE102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-704OSELTAMIVIR PHOSPHATE CAPSULE [EXELAN PHARMACEUTICALS, INC.]1Current NDC, 1 package rows20231209_31c90a2e-9d14-4236-8dc2-b2a862e8cbac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728109oseltamivir phosphate 30 MG Oral CapsulePSN31c90a2e-9d14-4236-8dc2-b2a862e8cbac2
728113oseltamivir phosphate 45 MG Oral CapsulePSN31c90a2e-9d14-4236-8dc2-b2a862e8cbac2
312122oseltamivir phosphate 75 MG Oral CapsulePSN31c90a2e-9d14-4236-8dc2-b2a862e8cbac2
728109oseltamivir 30 MG Oral CapsuleSCD31c90a2e-9d14-4236-8dc2-b2a862e8cbac2
728113oseltamivir 45 MG Oral CapsuleSCD31c90a2e-9d14-4236-8dc2-b2a862e8cbac2
312122oseltamivir 75 MG Oral CapsuleSCD31c90a2e-9d14-4236-8dc2-b2a862e8cbac2
728109oseltamivir (as oseltamivir phosphate) 30 MG Oral CapsuleSY31c90a2e-9d14-4236-8dc2-b2a862e8cbac2
728113oseltamivir (as oseltamivir phosphate) 45 MG Oral CapsuleSY31c90a2e-9d14-4236-8dc2-b2a862e8cbac2
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY31c90a2e-9d14-4236-8dc2-b2a862e8cbac2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76282-704-457628207044510 CAPSULE in 1 BLISTER PACK (76282-704-45) 10 capsule2023-12-01NoNoCurrent