FDA.reportPublic FDA data

Raloxifene Hydrochloride

Product NDC
69097-825
11-digit product format
690970825
Labeler code
69097
Product ID
69097-825_ebab2c47-9350-447a-9372-7ade623d5bb1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Raloxifene
Dosage form
TABLET
Route
ORAL
Labeler
Cipla USA Inc.
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

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
7ad62b49-6132-2a8c-4edd-73f39b2bf45cProduct name620210312
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69097-825-02Raloxifene Hydrochloride30 in 1 BOTTLETABLET304
69097-825-07Raloxifene Hydrochloride100 in 1 BOTTLETABLET1004
69097-825-15Raloxifene Hydrochloride1000 in 1 BOTTLETABLET10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-825-02EA - Each69097-8251d797514-c2f2-4bcc-871b-746d5f6f852f12016-07-19
69097-825-07EA - Each69097-82569c05953-9d94-469a-80df-99ecb9d1113912016-07-19
69097-825-15EA - Each69097-8255daae9d7-2877-463d-8749-40bd3fa7992812016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-825RALOXIFENE HYDROCHLORIDE (RALOXIFENE) TABLET [CIPLA USA INC.]4Current NDC, Legacy NDC, 3 package rows20201001_8fef5bfd-a786-4442-b09b-f3b81812cdac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1490065raloxifene HCl 60 MG Oral TabletPSNf5c25553-1546-451d-8069-c0f484c477418
1490065raloxifene hydrochloride 60 MG Oral TabletSCDf5c25553-1546-451d-8069-c0f484c477418
1490065raloxifene HCl 60 MG Oral TabletPSN8fef5bfd-a786-4442-b09b-f3b81812cdac4
1490065raloxifene hydrochloride 60 MG Oral TabletSCD8fef5bfd-a786-4442-b09b-f3b81812cdac4
1490065raloxifene HCl 60 MG Oral TabletPSNae557c81-e206-47fd-881e-b8f7fca2a3b02
1490065raloxifene hydrochloride 60 MG Oral TabletSCDae557c81-e206-47fd-881e-b8f7fca2a3b02
1490065raloxifene HCl 60 MG Oral TabletPSN35b5e3e5-0dfe-4abe-a928-d91dedd450e11
1490065raloxifene HCl 60 MG Oral TabletPSN53a2db10-4af8-4032-b598-b7c7a09698011
1490065raloxifene hydrochloride 60 MG Oral TabletSCD35b5e3e5-0dfe-4abe-a928-d91dedd450e11
1490065raloxifene hydrochloride 60 MG Oral TabletSCD53a2db10-4af8-4032-b598-b7c7a09698011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-825-026909708250230 TABLET in 1 BOTTLE (69097-825-02) 30 tablet2016-06-290000-00-00NoNoCurrent
69097-825-0769097082507100 TABLET in 1 BOTTLE (69097-825-07) 100 tablet2016-06-290000-00-00NoNoCurrent
69097-825-15690970825151000 TABLET in 1 BOTTLE (69097-825-15) 1000 tablet2016-06-290000-00-00NoNoCurrent