Oseltamivir phosphate

Product NDC
70518-3927
11-digit product format
705183927
Labeler code
70518
Product ID
70518-3927_3ba40b10-c008-03ae-e063-6394a90a8aac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA208348
Marketing category
ANDA
Marketing start
2023-11-28
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OSELTAMIVIR PHOSPHATE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4A3O49NGEZ

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
70518-3927-0Oseltamivir phosphate10 in 1 BLISTER PACKCAPSULE104
70518-3927-0Oseltamivir phosphate1 in 1 CARTONCAPSULE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3927OSELTAMIVIR PHOSPHATE CAPSULE [REMEDYREPACK INC.]3Current NDC, 2 package rows20240404_ad765459-e0d2-418e-8bae-8f6d16dfc1d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312122oseltamivir phosphate 75 MG Oral CapsulePSNad765459-e0d2-418e-8bae-8f6d16dfc1d84
312122oseltamivir 75 MG Oral CapsuleSCDad765459-e0d2-418e-8bae-8f6d16dfc1d84
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSYad765459-e0d2-418e-8bae-8f6d16dfc1d84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3927-0705183927001 BLISTER PACK in 1 CARTON (70518-3927-0) / 10 CAPSULE in 1 BLISTER PACK1 blister pack2023-11-28NoNoCurrent