LEUKERAN

Product NDC
69784-610
11-digit product format
697840610
Labeler code
69784
Product ID
69784-610_3f5cf902-16b6-45d9-8949-37e87cdd0e2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
chlorambucil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Woodward Pharma Services LLC
Application
NDA010669
Marketing category
NDA
Marketing start
2022-06-30
Marketing end
0000-00-00
Substance
CHLORAMBUCIL
Active strength
2 mg/1
Pharmacologic classes
Alkylating Activity [MoA], Alkylating Drug [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69784-610-252025-09-16C16284748780-12cef2736-9f69-d83d-e063-dadaa90ab31fe3d7a0f9-d704-4676-b16e-622ff6d22aa2
69784-610-252025-01-30C16284748780-12cef2736-9f69-d83d-e063-dadaa90ab31fe3d7a0f9-d704-4676-b16e-622ff6d22aa2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69784-610-25EA - Each69784-6109bb91ad0-eb02-4a47-a5b9-28ffdeeec27d12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69784-610LEUKERAN (CHLORAMBUCIL) TABLET, FILM COATED [WOODWARD PHARMA SERVICES LLC]2Legacy NDC20221230_e3d7a0f9-d704-4676-b16e-622ff6d22aa2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69784-610-256978406102525 TABLET, FILM COATED in 1 BOTTLE (69784-610-25) 2022-06-300000-00-00NoNoCurrent