Methadone Hydrochloride

Product NDC
68462-801
11-digit product format
684620801
Labeler code
68462
Product ID
68462-801_b34e28d6-4556-4170-b148-d6d37d02930f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methadone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Glenmark Pharmaceuticals, Inc., USA
Application
ANDA210484
Marketing category
ANDA
Marketing start
2018-08-06
Marketing end
0000-00-00
Substance
METHADONE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-801-01EA - Each68462-801054448f8-cc6f-42a1-acdd-00d86445e6a212019-01-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-801-0168462080101100 TABLET in 1 BOTTLE, PLASTIC (68462-801-01) 100 tablet2018-08-060000-00-00NoNoCurrent