FDA.reportPublic FDA data

Tamoxifen Citrate

Product NDC
59651-300
11-digit product format
596510300
Labeler code
59651
Product ID
59651-300_a596c715-8e30-43c1-aba3-4fe5de6729fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamoxifen Citrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA213358
Marketing category
ANDA
Marketing start
2020-08-14
Substance
TAMOXIFEN CITRATE
Active strength
20 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 CITRATE20 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
59651-300-30Tamoxifen Citrate30 in 1 BOTTLETABLET, FILM COATED301
59651-300-90Tamoxifen Citrate90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-300-30EA - Each59651-300a38a3268-1da3-45ff-812a-4de11d97c5f112021-01-08
59651-300-90EA - Each59651-300c27eed61-3777-42db-b175-f05eac7dd35e12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-300TAMOXIFEN CITRATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1Current NDC, Legacy NDC, 2 package rows20200821_a596c715-8e30-43c1-aba3-4fe5de6729fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313195tamoxifen citrate 20 MG Oral TabletPSN9b4a8abc-6e56-40c5-a826-1d1f3c0786e1101
313195tamoxifen 20 MG Oral TabletSCD9b4a8abc-6e56-40c5-a826-1d1f3c0786e1101
313195tamoxifen 20 MG (as tamoxifen citrate 30.4 MG) Oral TabletSY9b4a8abc-6e56-40c5-a826-1d1f3c0786e1101
198240tamoxifen citrate 10 MG Oral TabletPSNa596c715-8e30-43c1-aba3-4fe5de6729fa1
313195tamoxifen citrate 20 MG Oral TabletPSNa596c715-8e30-43c1-aba3-4fe5de6729fa1
198240tamoxifen 10 MG Oral TabletSCDa596c715-8e30-43c1-aba3-4fe5de6729fa1
313195tamoxifen 20 MG Oral TabletSCDa596c715-8e30-43c1-aba3-4fe5de6729fa1
198240tamoxifen 10 MG (as tamoxifen citrate 15.2 MG) Oral TabletSYa596c715-8e30-43c1-aba3-4fe5de6729fa1
313195tamoxifen 20 MG (as tamoxifen citrate 30.4 MG) Oral TabletSYa596c715-8e30-43c1-aba3-4fe5de6729fa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59651-300-305965103003030 TABLET, FILM COATED in 1 BOTTLE (59651-300-30) 2020-08-140000-00-00NoNoCurrent
59651-300-905965103009090 TABLET, FILM COATED in 1 BOTTLE (59651-300-90) 2020-08-140000-00-00NoNoCurrent