FDA.reportPublic FDA data

Tamoxifen Citrate

Product NDC
75907-058
11-digit product format
759070058
Labeler code
75907
Product ID
75907-058_f632608a-0743-4a7e-33a8-2ae28eccfcb9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamoxifen Citrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dr. Reddy's Labratories Inc.
Application
ANDA075797
Marketing category
ANDA
Marketing start
2024-08-22
Substance
TAMOXIFEN CITRATE
Active strength
10 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
Tamoxifen Citrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TAMOXIFEN CITRATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7FRV7310N6
Rxcui198240, 313195

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c3572c17-50b0-db2d-1012-2cc228ccf88fProduct name320201015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75907-058-10Tamoxifen Citrate1000 in 1 BOTTLETABLET, FILM COATED10001
75907-058-60Tamoxifen Citrate60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75907-058-10EA - Each75907-0585f5ec19a-9922-4e09-a58b-e958b2e9783e12024-09-09
75907-058-60EA - Each75907-058bc4595a7-e28e-4ff5-b40b-2f65fc09b95b12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75907-058TAMOXIFEN CITRATE TABLET, FILM COATED [DR. REDDY'S LABRATORIES INC.]1Current NDC, 2 package rows20240823_c6c6a643-57d6-7ea5-7da0-e8a66802468a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198240tamoxifen citrate 10 MG Oral TabletPSNc6c6a643-57d6-7ea5-7da0-e8a66802468a1
313195tamoxifen citrate 20 MG Oral TabletPSNc6c6a643-57d6-7ea5-7da0-e8a66802468a1
198240tamoxifen 10 MG Oral TabletSCDc6c6a643-57d6-7ea5-7da0-e8a66802468a1
313195tamoxifen 20 MG Oral TabletSCDc6c6a643-57d6-7ea5-7da0-e8a66802468a1
198240tamoxifen 10 MG (as tamoxifen citrate 15.2 MG) Oral TabletSYc6c6a643-57d6-7ea5-7da0-e8a66802468a1
313195tamoxifen 20 MG (as tamoxifen citrate 30.4 MG) Oral TabletSYc6c6a643-57d6-7ea5-7da0-e8a66802468a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
75907-058-10759070058101000 TABLET, FILM COATED in 1 BOTTLE (75907-058-10) 2024-08-22NoNoCurrent
75907-058-607590700586060 TABLET, FILM COATED in 1 BOTTLE (75907-058-60) 2024-08-22NoNoCurrent