Raloxifene Hydrochloride

Product NDC
43353-253
11-digit product format
433530253
Labeler code
43353
Product ID
43353-253_293b1286-f467-418f-9b40-e5502c14c3b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Raloxifene Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA204310
Marketing category
ANDA
Marketing start
2015-08-28
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-253-60EA - Each43353-253cf216224-039a-443e-9639-f795cb5ad07312017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-253RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20171005_786f2fa3-5a47-43a7-b4f5-fbb8f4de06fa.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-253-604335302536090 TABLET, FILM COATED in 1 BOTTLE (43353-253-60) 2016-11-150000-00-00NoNoCurrent