Tamoxifen Citrate

Product NDC
68071-3990
11-digit product format
680713990
Labeler code
68071
Product ID
68071-3990_50b2fd97-c6bd-843b-e063-6294a90ac6fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamoxifen Citrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA213358
Marketing category
ANDA
Marketing start
2020-08-14
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tamoxifen Citrate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TAMOXIFEN CITRATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7FRV7310N6
Rxcui198240

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
68071-3990-3Tamoxifen Citrate30 in 1 BOTTLETABLET, FILM COATED302

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198240tamoxifen citrate 10 MG Oral TabletPSN509f8ba3-214d-aec8-e063-6294a90af4982
198240tamoxifen 10 MG Oral TabletSCD509f8ba3-214d-aec8-e063-6294a90af4982
198240tamoxifen 10 MG (as tamoxifen citrate 15.2 MG) Oral TabletSY509f8ba3-214d-aec8-e063-6294a90af4982

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-3990-36807139900330 TABLET, FILM COATED in 1 BOTTLE (68071-3990-3) 2026-04-29NoNoHistorical