METHADONE HYDROCHLORIDE

Product NDC
0054-8553
11-digit product format
000548553
Labeler code
0054
Product ID
0054-8553_b2d1a6bb-c12c-428c-b21f-0d918d247570
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METHADONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
NDA006134
Marketing category
NDA
Marketing start
2001-10-11
Marketing end
2023-08-31
Substance
METHADONE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-8553-2400054855324100 BLISTER PACK in 1 CARTON (0054-8553-24) > 1 TABLET in 1 BLISTER PACK100 blister pack2001-10-112023-08-31NoNoCurrent