FDA.reportPublic FDA data

OSELTAMIVIR

Product NDC
46708-415
11-digit product format
467080415
Labeler code
46708
Product ID
46708-415_d5e4bb9c-4af2-407a-8c7d-d4c9cb5117f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OSELTAMIVIR
Dosage form
CAPSULE
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
c6022fcc-885e-41f7-971c-fe19ade5d9baProduct name920190926

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46708-415-102023-02-01C16284748780-1f386c649-f937-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use OSELTAMIVIR PHOSPHATE CAPSULES safely and effectively. See full prescribing information for OSELTAMIVIR PHOSPHATE CAPSULES. OSELTAMIVIR PHOSPHATE capsules, for oral use Initial U.S. Approval: 1999
46708-415-102023-01-30C16284748780-1f386c649-f937-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use OSELTAMIVIR PHOSPHATE CAPSULES safely and effectively. See full prescribing information for OSELTAMIVIR PHOSPHATE CAPSULES. OSELTAMIVIR PHOSPHATE capsules, for oral use Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-415-10OSELTAMIVIR10 in 1 CARTONCAPSULE102
46708-415-10OSELTAMIVIR1 in 1 BLISTER PACKCAPSULE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-415OSELTAMIVIR CAPSULE [ALEMBIC PHARMACEUTICALS LIMITED]2Current NDC, Legacy NDC, 2 package rows20230202_0a7181a6-e9eb-4047-a26f-4268f174db16.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728109oseltamivir phosphate 30 MG Oral CapsulePSN0a7181a6-e9eb-4047-a26f-4268f174db162
728113oseltamivir phosphate 45 MG Oral CapsulePSN0a7181a6-e9eb-4047-a26f-4268f174db162
312122oseltamivir phosphate 75 MG Oral CapsulePSN0a7181a6-e9eb-4047-a26f-4268f174db162
728109oseltamivir 30 MG Oral CapsuleSCD0a7181a6-e9eb-4047-a26f-4268f174db162
728113oseltamivir 45 MG Oral CapsuleSCD0a7181a6-e9eb-4047-a26f-4268f174db162
312122oseltamivir 75 MG Oral CapsuleSCD0a7181a6-e9eb-4047-a26f-4268f174db162
728109oseltamivir (as oseltamivir phosphate) 30 MG Oral CapsuleSY0a7181a6-e9eb-4047-a26f-4268f174db162
728113oseltamivir (as oseltamivir phosphate) 45 MG Oral CapsuleSY0a7181a6-e9eb-4047-a26f-4268f174db162
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY0a7181a6-e9eb-4047-a26f-4268f174db162

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46708-415-10467080415101 CARTON in 1 BLISTER PACK (46708-415-10) / 10 CAPSULE in 1 CARTON1 carton2019-06-250000-00-00NoNoCurrent