Oseltamivir Phosphate

Product NDC
50090-7346
11-digit product format
500907346
Labeler code
50090
Product ID
50090-7346_b4f2d2eb-d365-479d-b63d-63fdf95344bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oseltamivir phosphate
Dosage form
SUSPENSION
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA213594
Marketing category
ANDA
Marketing start
2023-07-13
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
c6022fcc-885e-41f7-971c-fe19ade5d9baProduct name920190926
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7346-0Oseltamivir Phosphate1 in 1 CARTONSUSPENSION11
50090-7346-0Oseltamivir Phosphate60 mL in 1 BOTTLE, PLASTICSUSPENSION601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7346-0ML - Milliliter50090-734610d5b3f8-9199-4b57-822c-8b348c19bfd212024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7346OSELTAMIVIR PHOSPHATE SUSPENSION [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20241023_40390bf9-f2c4-4608-b5c4-315457b92821.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115698oseltamivir phosphate 6 MG in 1 mL Oral SuspensionPSN40390bf9-f2c4-4608-b5c4-315457b928211
1115698oseltamivir 6 MG/ML Oral SuspensionSCD40390bf9-f2c4-4608-b5c4-315457b928211
1115698oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral SuspensionSY40390bf9-f2c4-4608-b5c4-315457b928211
1115698oseltamivir phosphate 6 MG per 1 ML Oral SuspensionSY40390bf9-f2c4-4608-b5c4-315457b928211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7346-0500907346001 BOTTLE, PLASTIC in 1 CARTON (50090-7346-0) / 60 mL in 1 BOTTLE, PLASTIC2024-10-16NoNoCurrent