Raloxifene hydrochloride

Product NDC
50090-6177
11-digit product format
500906177
Labeler code
50090
Product ID
50090-6177_88a25d54-f913-4a43-9f04-9ab1979ff633
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Raloxifene hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
A-S Medication Solutions
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
50090-6177-1Raloxifene hydrochloride90 in 1 BOTTLETABLET, COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6177-1EA - Each50090-6177e3bc3de7-acdd-482d-adba-146b02c7100a12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6177RALOXIFENE HYDROCHLORIDE TABLET, COATED [A-S MEDICATION SOLUTIONS]4Current NDC, Legacy NDC, 1 package rows20231102_22a951ee-2ffc-4c60-b681-0f80285153e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1490065raloxifene HCl 60 MG Oral TabletPSN22a951ee-2ffc-4c60-b681-0f80285153e14
1490065raloxifene hydrochloride 60 MG Oral TabletSCD22a951ee-2ffc-4c60-b681-0f80285153e14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-6177-15009061770190 TABLET, COATED in 1 BOTTLE (50090-6177-1) 2022-10-180000-00-00NoNoCurrent