FDA.reportPublic FDA data

Raloxifene Hydrochloride

Product NDC
0440-5295
11-digit product format
004405295
Labeler code
0440
Product ID
0440-5295_3a9a9dae-0c0a-465f-887a-bd7454e4c79c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Raloxifene Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Liberty Pharmaceuticals, Inc.
Application
ANDA090842
Marketing category
ANDA
Marketing start
2014-11-12
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
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7ad62b49-6132-2a8c-4edd-73f39b2bf45cProduct name620210312

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0440-5295-012020-01-31C16284748780-19d75b9cf-de59-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use raloxifene hydrochloride tablets, USP safely and effectively. See full prescribing information for raloxifene hydrochloride tablets, USP. Raloxifene Hydrochloride Tablets, USP for Oral Use Initial U.S. Approval: 1997
0440-5295-052020-01-31C16284748780-19d75b9cf-de59-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use raloxifene hydrochloride tablets, USP safely and effectively. See full prescribing information for raloxifene hydrochloride tablets, USP. Raloxifene Hydrochloride Tablets, USP for Oral Use Initial U.S. Approval: 1997
0440-5295-302020-01-31C16284748780-19d75b9cf-de59-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use raloxifene hydrochloride tablets, USP safely and effectively. See full prescribing information for raloxifene hydrochloride tablets, USP. Raloxifene Hydrochloride Tablets, USP for Oral Use Initial U.S. Approval: 1997
0440-5295-602020-01-31C16284748780-19d75b9cf-de59-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use raloxifene hydrochloride tablets, USP safely and effectively. See full prescribing information for raloxifene hydrochloride tablets, USP. Raloxifene Hydrochloride Tablets, USP for Oral Use Initial U.S. Approval: 1997
0440-5295-812020-01-31C16284748780-19d75b9cf-de59-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use raloxifene hydrochloride tablets, USP safely and effectively. See full prescribing information for raloxifene hydrochloride tablets, USP. Raloxifene Hydrochloride Tablets, USP for Oral Use Initial U.S. Approval: 1997
0440-5295-902020-01-31C16284748780-19d75b9cf-de59-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use raloxifene hydrochloride tablets, USP safely and effectively. See full prescribing information for raloxifene hydrochloride tablets, USP. Raloxifene Hydrochloride Tablets, USP for Oral Use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0440-5295-01Raloxifene Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1002
0440-5295-05Raloxifene Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5002
0440-5295-30Raloxifene Hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
0440-5295-60Raloxifene Hydrochloride60 in 1 BOTTLETABLET, FILM COATED602
0440-5295-81Raloxifene Hydrochloride300 in 1 BOTTLETABLET, FILM COATED3002
0440-5295-90Raloxifene Hydrochloride90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0440-5295-05EA - Each0440-529538163895-790e-4b41-8f1b-ad549ef1cd4112017-08-11
0440-5295-30EA - Each0440-5295d7e80340-aa20-4051-a1c5-f877529630af12017-08-11
0440-5295-60EA - Each0440-52954bcb3859-54ac-4ab6-b8d4-4f9fc604c1fa12017-08-11
0440-5295-81EA - Each0440-52958daf2f69-12ff-4b0c-96e8-f1a4493f82b312018-04-19
0440-5295-90EA - Each0440-529518d24795-bd09-4225-bb13-2712357c4b7412017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0440-5295RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]2Legacy NDC, 6 package rows20161019_c9b60ef1-c88b-4363-9a28-5854b7ff8a50.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1490065raloxifene HCl 60 MG Oral TabletPSNc9b60ef1-c88b-4363-9a28-5854b7ff8a502
1490065raloxifene hydrochloride 60 MG Oral TabletSCDc9b60ef1-c88b-4363-9a28-5854b7ff8a502

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0440-5295-0100440529501100 in 1 BOTTLEHistorical
0440-5295-0500440529505500 in 1 BOTTLEHistorical
0440-5295-300044052953030 in 1 BOTTLEHistorical
0440-5295-600044052956060 in 1 BOTTLEHistorical
0440-5295-8100440529581300 in 1 BOTTLEHistorical
0440-5295-900044052959090 in 1 BOTTLEHistorical