FDA.reportPublic FDA data

Oseltamivir Phosphate

Product NDC
68788-7600
11-digit product format
687887600
Labeler code
68788
Product ID
68788-7600_c0622a5a-99ef-40df-9e02-1b1321d97f98
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir Phosphate
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA209113
Marketing category
ANDA
Marketing start
2020-02-13
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
c6022fcc-885e-41f7-971c-fe19ade5d9baProduct name920190926

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7600-6Oseltamivir Phosphate1 in 1 CARTONFOR SUSPENSION16
68788-7600-6Oseltamivir Phosphate60 mL in 1 BOTTLEFOR SUSPENSION606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7600-6ML - Milliliter68788-7600a30496ac-17f5-42fc-8988-2a8381ce63bd12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7600OSELTAMIVIR PHOSPHATE FOR SUSPENSION [PREFERRED PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 2 package rows20240726_b1abef84-d074-4872-9193-48a52cbabbd6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115698oseltamivir phosphate 6 MG in 1 mL Oral SuspensionPSNb1abef84-d074-4872-9193-48a52cbabbd66
1115698oseltamivir 6 MG/ML Oral SuspensionSCDb1abef84-d074-4872-9193-48a52cbabbd66
1115698oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral SuspensionSYb1abef84-d074-4872-9193-48a52cbabbd66
1115698oseltamivir phosphate 6 MG per 1 ML Oral SuspensionSYb1abef84-d074-4872-9193-48a52cbabbd66

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7600-6687887600061 BOTTLE in 1 CARTON (68788-7600-6) / 60 mL in 1 BOTTLE1 bottle2020-02-130000-00-00NoNoCurrent