Tamoxifen Citrate

Product NDC
51862-446
11-digit product format
518620446
Labeler code
51862
Product ID
51862-446_729b8661-687d-4cc9-b0fd-6bdd09282abb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamoxifen Citrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mayne Pharma Inc.
Application
ANDA075797
Marketing category
ANDA
Marketing start
2016-08-03
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
51862-446-01EA - Each51862-4464c1ea75e-4a07-43ed-b5e3-81c1e567194f12016-11-08
51862-446-05EA - Each51862-4466c553eb4-2145-416b-97c3-ec3b8005545412016-11-08
51862-446-10EA - Each51862-446f643b620-9f70-4e21-bbfb-a2e7af8f81b012016-11-08
51862-446-30EA - Each51862-44610ba8a6f-862c-448b-b027-06ec323ebcd312017-03-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51862-446-0151862044601100 TABLET, FILM COATED in 1 BOTTLE (51862-446-01) 2016-08-030000-00-00NoNoCurrent
51862-446-0551862044605500 TABLET, FILM COATED in 1 BOTTLE (51862-446-05) 2016-08-030000-00-00NoNoCurrent
51862-446-10518620446101000 TABLET, FILM COATED in 1 BOTTLE (51862-446-10) 2016-08-030000-00-00NoNoCurrent
51862-446-305186204463030 TABLET, FILM COATED in 1 BOTTLE (51862-446-30) 2016-08-030000-00-00NoNoCurrent