FDA.reportPublic FDA data

Oseltamivir Phosphate

Product NDC
50090-3710
11-digit product format
500903710
Labeler code
50090
Product ID
50090-3710_46d9feb1-02f0-4261-a981-b84f2aad7c2a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir Phosphate
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA209113
Marketing category
ANDA
Marketing start
2017-09-14
Marketing end
0000-00-00
Substance
OSELTAMIVIR PHOSPHATE
Active strength
6 mg/mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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
50090-3710-02023-01-30C16284748780-1f386c649-c436-0266-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
50090-3710-0Oseltamivir Phosphate1 in 1 CARTONFOR SUSPENSION14
50090-3710-0Oseltamivir Phosphate60 mL in 1 BOTTLEFOR SUSPENSION604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3710OSELTAMIVIR PHOSPHATE FOR SUSPENSION [A-S MEDICATION SOLUTIONS]4Legacy NDC, 2 package rows20200121_9a486c32-1cc8-465c-bf57-43e71b09446e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115698oseltamivir phosphate 6 MG in 1 mL Oral SuspensionPSN9a486c32-1cc8-465c-bf57-43e71b09446e4
1115698oseltamivir 6 MG/ML Oral SuspensionSCD9a486c32-1cc8-465c-bf57-43e71b09446e4
1115698oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral SuspensionSY9a486c32-1cc8-465c-bf57-43e71b09446e4
1115698oseltamivir phosphate 6 MG per 1 ML Oral SuspensionSY9a486c32-1cc8-465c-bf57-43e71b09446e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3710-0500903710001 BOTTLE in 1 CARTON (50090-3710-0) > 60 mL in 1 BOTTLE1 bottle2018-10-230000-00-00NoNoCurrent