ALKERAN

Product NDC
52609-0001
11-digit product format
526090001
Labeler code
52609
Product ID
52609-0001_e2b5e294-02e5-12c5-99e7-3b90b136ed63
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
melphalan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ApoPharma USA, Inc.
Application
NDA014691
Marketing category
NDA
Marketing start
2011-01-01
Marketing end
0000-00-00
Substance
MELPHALAN
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52609-0001-5EA - Each52609-0001fddcc581-d0d4-4056-bb2f-34ed0e1964ee12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52609-0001-55260900010550 TABLET, FILM COATED in 1 BOTTLE (52609-0001-5) 2011-01-010000-00-00NoNoCurrent