FDA.reportPublic FDA data

Raloxifene hydrochloride

Product NDC
72162-2418
11-digit product format
721622418
Labeler code
72162
Product ID
72162-2418_098f2903-afc3-4a47-8c22-9cc1ce9d50c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Raloxifene hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA211324
Marketing category
ANDA
Marketing start
2017-12-30
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

Additional Listing Data#

Finished product
Yes
Brand name base
Raloxifene hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RALOXIFENE HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4F86W47BR6
Rxcui1490065

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2418-0Raloxifene hydrochloride1000 in 1 BOTTLETABLET, COATED1000100
72162-2418-1Raloxifene hydrochloride100 in 1 BOTTLETABLET, COATED100100
72162-2418-3Raloxifene hydrochloride30 in 1 BOTTLETABLET, COATED30100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2418-0EA - Each72162-24186c7fb739-b1a1-4b48-a47d-1b1e0e4ecdb412024-12-10
72162-2418-1EA - Each72162-2418e159804c-3f49-4c54-b439-1c3ad87b4b4912024-12-10
72162-2418-3EA - Each72162-241895fd3c52-ac1e-4f55-a2f4-ece16dfcd7ed12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2418RALOXIFENE HYDROCHLORIDE TABLET, COATED [BRYANT RANCH PREPACK]100Current NDC, 3 package rows20241102_7e4bfee5-fefc-4115-9bdb-222eccefca83.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1490065raloxifene HCl 60 MG Oral TabletPSN7e4bfee5-fefc-4115-9bdb-222eccefca83100
1490065raloxifene hydrochloride 60 MG Oral TabletSCD7e4bfee5-fefc-4115-9bdb-222eccefca83100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2418-0721622418001000 TABLET, COATED in 1 BOTTLE (72162-2418-0) 2024-10-31NoNoCurrent
72162-2418-172162241801100 TABLET, COATED in 1 BOTTLE (72162-2418-1) 2024-10-31NoNoCurrent
72162-2418-37216224180330 TABLET, COATED in 1 BOTTLE (72162-2418-3) 2024-10-31NoNoCurrent