Raloxifene Hydrochloride

Product NDC
71610-524
11-digit product format
716100524
Labeler code
71610
Product ID
71610-524_4dfb7a20-54ea-4e48-9f0d-03099593073f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Raloxifene
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA090842
Marketing category
ANDA
Marketing start
2016-06-29
Substance
RALOXIFENE HYDROCHLORIDE
Active strength
60 mg/1
Pharmacologic classes
Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
4F86W47BR6RALOXIFENE HYDROCHLORIDE82640-04-8RALOXIFENE HYDROCHLORIDE
YX9162EO3IRALOXIFENE84449-90-1Raloxifene

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-524-607161005246090 TABLET in 1 BOTTLE (71610-524-60) 90 tablet2021-02-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Raloxifene HydrochlorideAphena Pharma Solutions - Tennessee, LLC2021-03-17HUMAN PRESCRIPTION DRUG LABEL1