Oseltamivir Phosphate

Product NDC
50090-4188
11-digit product format
500904188
Labeler code
50090
Product ID
50090-4188_18da07a0-8914-4e1a-9196-1ac023659e3d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir Phosphate
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA208347
Marketing category
ANDA
Marketing start
2018-02-21
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

openFDA Listing Details

Product ID
50090-4188_18da07a0-8914-4e1a-9196-1ac023659e3d
SPL ID
18da07a0-8914-4e1a-9196-1ac023659e3d
Product type
HUMAN PRESCRIPTION DRUG
Finished product
Yes
Brand name base
Oseltamivir Phosphate
Generic name
Oseltamivir Phosphate
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Marketing start
2018-02-21
Marketing category
ANDA
Application number
ANDA208347
Pharmacologic classes
Neuraminidase Inhibitor [EPC]; Neuraminidase Inhibitors [MoA]
Listing expiration
2026-12-31

openFDA Active Ingredients

IngredientStrength
OSELTAMIVIR PHOSPHATE6 mg/mL

openFDA Harmonized Identifiers

FieldValues
Unii4A3O49NGEZ
Rxcui1115698
Spl Set Id5194bb90-0876-48c4-a967-c862fbccd110
Manufacturer NameA-S Medication Solutions

openFDA Package Details

Package NDCDescriptionMarketing startSample
50090-4188-01 BOTTLE, GLASS in 1 CARTON (50090-4188-0) / 60 mL in 1 BOTTLE, GLASS2019-03-14No

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
4A3O49NGEZOSELTAMIVIR PHOSPHATE204255-11-8OSELTAMIVIR PHOSPHATE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-4188-0500904188001 BOTTLE, GLASS in 1 CARTON (50090-4188-0) / 60 mL in 1 BOTTLE, GLASS2019-03-14NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Oseltamivir PhosphateA-S Medication Solutions2023-07-06HUMAN PRESCRIPTION DRUG LABEL5