OSELTAMIVIR PHOSPHATE

Product NDC
69315-174
11-digit product format
693150174
Labeler code
69315
Product ID
69315-174_473d55b2-bec6-4f76-b5a2-275431b2eb09
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OSELTAMIVIR PHOSPHATE
Dosage form
SUSPENSION
Route
ORAL
Labeler
Leading Pharma, LLC
Application
ANDA214949
Marketing category
ANDA
Marketing start
2022-06-01
Substance
OSELTAMIVIR PHOSPHATE
Active strength
6 mg/mL
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 PHOSPHATE6 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4A3O49NGEZ
Rxcui1115698

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
69315-174-60OSELTAMIVIR PHOSPHATE60 mL in 1 BOTTLESUSPENSION608

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69315-174OSELTAMIVIR PHOSPHATE SUSPENSION [LEADING PHARMA, LLC]8Current NDC, Legacy NDC, 1 package rows20241009_ef093e4d-5b1a-463f-a1a3-b795a4387a81.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115698oseltamivir phosphate 6 MG in 1 mL Oral SuspensionPSNef093e4d-5b1a-463f-a1a3-b795a4387a818
1115698oseltamivir 6 MG/ML Oral SuspensionSCDef093e4d-5b1a-463f-a1a3-b795a4387a818
1115698oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral SuspensionSYef093e4d-5b1a-463f-a1a3-b795a4387a818
1115698oseltamivir phosphate 6 MG per 1 ML Oral SuspensionSYef093e4d-5b1a-463f-a1a3-b795a4387a818

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69315-174-606931501746060 mL in 1 BOTTLE (69315-174-60) 60 ml2022-06-010000-00-00NoNoCurrent