EVOMELA

Product NDC
68152-109
11-digit product format
681520109
Labeler code
68152
Product ID
68152-109_dd7dd217-449f-49aa-b839-eee22d963459
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Melphalan
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Acrotech Biopharma LLC
Application
NDA207155
Marketing category
NDA
Marketing start
2016-03-31
Marketing end
0000-00-00
Substance
MELPHALAN HYDROCHLORIDE
Active strength
50 mg/10mL
Pharmacologic classes
Alkylating Activity [MoA],Alkylating Drug [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68152-109-002023-04-18C16284748780-1f386c649-b1de-0266-e053-dadaa90a7c1ac5d68b96-14bd-4605-b6d2-2bf8b0c5ca8a
68152-109-002023-01-30C16284748780-1f386c649-b1de-0266-e053-dadaa90a7c1ac5d68b96-14bd-4605-b6d2-2bf8b0c5ca8a

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68152-109-00EA - Each68152-10998b13d80-8a9f-4227-bd97-6c90e421a11012016-05-16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68152-109-00681520109001 VIAL in 1 CARTON (68152-109-00) > 20 mL in 1 VIAL1 vial2016-03-312022-03-31NoNoCurrent