OSELTAMIVIR

Product NDC
62332-415
11-digit product format
623320415
Labeler code
62332
Product ID
62332-415_2cf2a156-c13d-4e8e-a7e4-eac265e31492
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OSELTAMIVIR
Dosage form
CAPSULE
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA211823
Marketing category
ANDA
Marketing start
2019-06-25
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
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
62332-415-10OSELTAMIVIR10 in 1 CARTONCAPSULE1012
62332-415-10OSELTAMIVIR1 in 1 BLISTER PACKCAPSULE112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-415-10EA - Each62332-415108f15d6-257a-42bf-8ff3-9c3b3cbb498c12019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-415OSELTAMIVIR CAPSULE [ALEMBIC PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 2 package rows20211223_82685c2f-791b-440f-a1c2-5a032da7adca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728109oseltamivir phosphate 30 MG Oral CapsulePSN82685c2f-791b-440f-a1c2-5a032da7adca12
728113oseltamivir phosphate 45 MG Oral CapsulePSN82685c2f-791b-440f-a1c2-5a032da7adca12
312122oseltamivir phosphate 75 MG Oral CapsulePSN82685c2f-791b-440f-a1c2-5a032da7adca12
728109oseltamivir 30 MG Oral CapsuleSCD82685c2f-791b-440f-a1c2-5a032da7adca12
728113oseltamivir 45 MG Oral CapsuleSCD82685c2f-791b-440f-a1c2-5a032da7adca12
312122oseltamivir 75 MG Oral CapsuleSCD82685c2f-791b-440f-a1c2-5a032da7adca12
728109oseltamivir (as oseltamivir phosphate) 30 MG Oral CapsuleSY82685c2f-791b-440f-a1c2-5a032da7adca12
728113oseltamivir (as oseltamivir phosphate) 45 MG Oral CapsuleSY82685c2f-791b-440f-a1c2-5a032da7adca12
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY82685c2f-791b-440f-a1c2-5a032da7adca12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-415-10623320415101 CARTON in 1 BLISTER PACK (62332-415-10) / 10 CAPSULE in 1 CARTON1 carton2019-06-250000-00-00NoNoCurrent