Tamoxifen Citrate

Product NDC
68382-826
11-digit product format
683820826
Labeler code
68382
Product ID
68382-826_3c910886-2c1b-4da0-944d-c7064b571d24
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamoxifen Citrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA206694
Marketing category
ANDA
Marketing start
2018-01-03
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-826-14EA - Each68382-826dd715821-2630-4599-9b98-288107d77f6612018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-826TAMOXIFEN CITRATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.]5Legacy NDC20221115_fa87c1c2-f58b-4a12-a658-a957ae7e522d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68382-826-0168382082601100 TABLET, FILM COATED in 1 BOTTLE (68382-826-01) 2018-01-030000-00-00NoNoCurrent
68382-826-146838208261460 TABLET, FILM COATED in 1 BOTTLE (68382-826-14) 2018-01-030000-00-00NoNoCurrent
68382-826-166838208261690 TABLET, FILM COATED in 1 BOTTLE (68382-826-16) 2018-01-030000-00-00NoNoCurrent
68382-826-2868382082628180 TABLET, FILM COATED in 1 BOTTLE (68382-826-28) 2018-01-030000-00-00NoNoCurrent