FDA.reportPublic FDA data

Oseltamivir Phosphate

Product NDC
50090-4613
11-digit product format
500904613
Labeler code
50090
Product ID
50090-4613_ee451747-800b-4401-9573-6d260fc5e13d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir Phosphate
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA211125
Marketing category
ANDA
Marketing start
2019-07-10
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4613-02023-02-07C16284748780-1f386c64a-4841-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use OSELTAMIVIR PHOSPHATE FOR ORAL SUSPENSION safely and effectively. See full prescribing information for OSELTAMIVIR PHOSPHATE FOR ORAL SUSPENSION. OSELTAMIVIR PHOSPHATE for oral suspension Initial U.S. Approval: 1999
50090-4613-02023-01-30C16284748780-1f386c64a-4841-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use OSELTAMIVIR PHOSPHATE FOR ORAL SUSPENSION safely and effectively. See full prescribing information for OSELTAMIVIR PHOSPHATE FOR ORAL SUSPENSION. OSELTAMIVIR PHOSPHATE for oral suspension Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4613-0Oseltamivir Phosphate60 mL in 1 BOTTLEPOWDER, FOR SUSPENSION606
50090-4613-0Oseltamivir Phosphate1 in 1 CARTONPOWDER, FOR SUSPENSION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4613-0ML - Milliliter50090-461370f090ed-e3c5-4148-8f19-b6ae116c541512023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4613OSELTAMIVIR PHOSPHATE POWDER, FOR SUSPENSION [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 2 package rows20230208_73d7fa5a-8304-44b7-9456-58926a265d81.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115698oseltamivir phosphate 6 MG in 1 mL Oral SuspensionPSN73d7fa5a-8304-44b7-9456-58926a265d816
1115698oseltamivir 6 MG/ML Oral SuspensionSCD73d7fa5a-8304-44b7-9456-58926a265d816
1115698oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral SuspensionSY73d7fa5a-8304-44b7-9456-58926a265d816
1115698oseltamivir phosphate 6 MG per 1 ML Oral SuspensionSY73d7fa5a-8304-44b7-9456-58926a265d816

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4613-0500904613001 BOTTLE in 1 CARTON (50090-4613-0) / 60 mL in 1 BOTTLE1 bottle2019-10-150000-00-00NoNoCurrent