Tamoxifen Citrate

Product NDC
68382-827
11-digit product format
683820827
Labeler code
68382
Product ID
68382-827_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
20 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
68382-827-01EA - Each68382-8271c70f0df-cd4f-44c8-849f-a9d63e9e25bf12018-04-19
68382-827-06EA - Each68382-827c39fcada-5727-4460-85d2-2f152d46ea9712018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-827TAMOXIFEN 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
68382-827-0168382082701100 TABLET, FILM COATED in 1 BOTTLE (68382-827-01) 2018-01-030000-00-00NoNoCurrent
68382-827-066838208270630 TABLET, FILM COATED in 1 BOTTLE (68382-827-06) 2018-01-030000-00-00NoNoCurrent
68382-827-10683820827101000 TABLET, FILM COATED in 1 BOTTLE (68382-827-10) 2018-01-030000-00-00NoNoCurrent
68382-827-146838208271460 TABLET, FILM COATED in 1 BOTTLE (68382-827-14) 2018-01-030000-00-00NoNoCurrent
68382-827-166838208271690 TABLET, FILM COATED in 1 BOTTLE (68382-827-16) 2018-01-030000-00-00NoNoCurrent