FDA.reportPublic FDA data

Oseltamivir Phosphate

Product NDC
70518-3247
11-digit product format
705183247
Labeler code
70518
Product ID
70518-3247_4ceca2b4-9372-1174-e063-6294a90a6381
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir Phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA209438
Marketing category
ANDA
Marketing start
2021-10-18
Substance
OSELTAMIVIR PHOSPHATE
Active strength
75 mg/1
Pharmacologic classes
Neuraminidase Inhibitor [EPC], Neuraminidase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Oseltamivir Phosphate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OSELTAMIVIR PHOSPHATE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4A3O49NGEZ
Rxcui312122

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6022fcc-885e-41f7-971c-fe19ade5d9baProduct name920190926

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3247-02023-03-23C16284748780-1f386c64a-278c-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
70518-3247-02023-01-30C16284748780-1f386c64a-278c-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
70518-3247-0Oseltamivir Phosphate10 in 1 CARTONCAPSULE107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3247OSELTAMIVIR PHOSPHATE CAPSULE [REMEDYREPACK INC.]4Current NDC, Legacy NDC, 1 package rows20240322_ad90fe42-8d52-403e-9b07-b8536fbf335a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312122oseltamivir phosphate 75 MG Oral CapsulePSNad90fe42-8d52-403e-9b07-b8536fbf335a7
312122oseltamivir 75 MG Oral CapsuleSCDad90fe42-8d52-403e-9b07-b8536fbf335a7
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSYad90fe42-8d52-403e-9b07-b8536fbf335a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3247-07051832470010 CAPSULE in 1 CARTON (70518-3247-0) 10 capsule2021-10-180000-00-00NoNoCurrent