Oseltamivir phosphate

Product NDC
68071-3960
11-digit product format
680713960
Labeler code
68071
Product ID
68071-3960_497adf87-f393-e52c-e063-6394a90a4a50
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir phosphate
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA212784
Marketing category
ANDA
Marketing start
2020-05-28
Substance
OSELTAMIVIR PHOSPHATE
Active strength
6 mg/mL
Pharmacologic classes
Neuraminidase Inhibitor [EPC], Neuraminidase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Oseltamivir phosphate
Listing expiration
2027-12-31

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
68071-3960-6Oseltamivir phosphate1 in 1 CARTONFOR SUSPENSION11
68071-3960-6Oseltamivir phosphate1 in 1 POUCHFOR SUSPENSION11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115698oseltamivir phosphate 6 MG in 1 mL Oral SuspensionPSN497adf7b-9bdc-314e-e063-6394a90a63be1
1115698oseltamivir 6 MG/ML Oral SuspensionSCD497adf7b-9bdc-314e-e063-6394a90a63be1
1115698oseltamivir (as oseltamivir phosphate) 6 MG/ML Oral SuspensionSY497adf7b-9bdc-314e-e063-6394a90a63be1
1115698oseltamivir phosphate 6 MG per 1 ML Oral SuspensionSY497adf7b-9bdc-314e-e063-6394a90a63be1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3960-6680713960061 POUCH in 1 CARTON (68071-3960-6) / 1 BOTTLE in 1 POUCH / 60 mL in 1 BOTTLE1 pouch2026-01-28NoNoHistorical