Methadone Hydrocloride

Product NDC
0527-1926
11-digit product format
005271926
Labeler code
0527
Product ID
0527-1926_6714ab49-287c-460f-84c6-4a2eb909b896
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methadone hydrochloride
Dosage form
CONCENTRATE
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA212094
Marketing category
ANDA
Marketing start
2021-03-03
Marketing end
0000-00-00
Substance
METHADONE HYDROCHLORIDE
Active strength
10 mg/mL
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-1926METHADONE HYDROCLORIDE (METHADONE HYDROCHLORIDE) CONCENTRATE [LANNETT COMPANY, INC.]11Legacy NDC20220517_119da5aa-bb8a-47cc-afb6-bcd2040a92a3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-1926-36005271926361 BOTTLE, PLASTIC in 1 CARTON (0527-1926-36) > 30 mL in 1 BOTTLE, PLASTIC2021-03-030000-00-00NoNoCurrent
0527-1926-39005271926391000 mL in 1 BOTTLE, PLASTIC (0527-1926-39) 1000 ml2021-03-030000-00-00NoNoCurrent