Oseltamivir Phosphate

Product NDC
76420-597
11-digit product format
764200597
Labeler code
76420
Product ID
76420-597_045b5851-b429-0639-e063-6394a90aa208
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir Phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA209421
Marketing category
ANDA
Marketing start
2018-10-05
Substance
OSELTAMIVIR PHOSPHATE
Active strength
75 mg/1
Pharmacologic classes
Neuraminidase Inhibitor [EPC], Neuraminidase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-597-107642005971010 CAPSULE in 1 BLISTER PACK (76420-597-10) 10 capsule2023-09-02NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Oseltamivir PhosphateAsclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM2023-09-02HUMAN PRESCRIPTION DRUG LABEL1