FDA.reportPublic FDA data

Raloxifene hydrochloride

Product NDC
71209-082
11-digit product format
712090082
Labeler code
71209
Product ID
71209-082_14d4c334-b49d-4479-a91e-20b7276b4eca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Raloxifene hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Cadila Pharmaceuticals Limited
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
71209-082-01Raloxifene hydrochloride30 in 1 BOTTLETABLET, COATED305
71209-082-05Raloxifene hydrochloride100 in 1 BOTTLETABLET, COATED1005
71209-082-11Raloxifene hydrochloride1000 in 1 BOTTLETABLET, COATED10005
71209-082-13Raloxifene hydrochloride2000 in 1 BOTTLETABLET, COATED20005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71209-082RALOXIFENE HYDROCHLORIDE TABLET, COATED [CADILA PHARMACEUTICALS LIMITED]5Current NDC, Legacy NDC, 4 package rows20220120_a46bcc4f-f63d-4200-836d-a653a3c616db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1490065raloxifene HCl 60 MG Oral TabletPSNa46bcc4f-f63d-4200-836d-a653a3c616db5
1490065raloxifene hydrochloride 60 MG Oral TabletSCDa46bcc4f-f63d-4200-836d-a653a3c616db5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71209-082-017120900820130 TABLET, COATED in 1 BOTTLE (71209-082-01) 2017-12-300000-00-00NoNoCurrent
71209-082-0571209008205100 TABLET, COATED in 1 BOTTLE (71209-082-05) 2017-12-300000-00-00NoNoCurrent
71209-082-11712090082111000 TABLET, COATED in 1 BOTTLE (71209-082-11) 2021-12-130000-00-00NoNoCurrent
71209-082-13712090082132000 TABLET, COATED in 1 BOTTLE (71209-082-13) 2017-12-300000-00-00NoNoCurrent