Methadone Hydrochloride

Product NDC
0406-1510
11-digit product format
004061510
Labeler code
0406
Product ID
0406-1510_fb536c3e-1f0b-4364-b83a-a83d190f59db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methadone Hydrochloride
Dosage form
POWDER
Route
ORAL
Labeler
Mallinckrodt, Inc.
Application
NDA006383
Marketing category
NDA
Marketing start
2012-04-30
Marketing end
2023-05-31
Substance
METHADONE HYDROCHLORIDE
Active strength
1 g/g
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

Additional Listing Data#

Finished product
No
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHADONE HYDROCHLORIDE1 kg/kg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0406-1510-56GM - Gram0406-15109a0ab592-1130-4db2-9c89-0df6150dc00a12013-02-13
0406-1510-57GM - Gram0406-1510184f2761-3774-4fdc-992d-efb0cfd04d2f12013-02-13
0406-1510-59GM - Gram0406-1510eef8a79f-81a6-4233-b121-ac37702fa35412013-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endStatus
0406-1510-06004061510061 kg in 1 DRUM (0406-1510-06)1 kg30-APR-1201-MAR-31Historical
0406-1510-4000406151040.5 kg in 1 BOTTLE, GLASS (0406-1510-40)01-JAN-25Current
0406-1510-410040615104110 kg in 1 PAIL (0406-1510-41)10 kg01-JAN-25Current
0406-1510-420040615104250 kg in 1 DRUM (0406-1510-42)50 kg01-JAN-25Current
0406-1510-5600406151056.05 kg in 1 BOTTLE (0406-1510-56)30-APR-12Current
0406-1510-5700406151057.1 kg in 1 BOTTLE, GLASS (0406-1510-57)30-APR-12Current