FDA.reportPublic FDA data

METHADOSE

Product NDC
0406-8725
11-digit product format
004068725
Labeler code
0406
Product ID
0406-8725_eac074c9-ea47-4a82-a4c3-1149c30bf372
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methadone hydrochloride
Dosage form
CONCENTRATE
Route
ORAL
Labeler
SpecGx LLC
Application
NDA017116
Marketing category
NDA
Marketing start
1973-03-14
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
METHADOSE
Brand name suffix
SUGAR-FREE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHADONE HYDROCHLORIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii229809935B
Rxcui991147, 991149

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bc6c52c8-e3e2-9042-21d0-6770dcf1a49bProduct name320250819
a48f0261-b6cc-12b3-49fd-ed131bc5aa96Product name420210902
00dcb24c-d95e-78f6-6c1b-4d7b709bb2b9Product name620200708
a6a96832-f31d-b458-45cb-abb8bd940b44Product name220200304

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0406-8725-10METHADOSESUGAR-FREE1000 mL in 1 BOTTLE, PLASTICCONCENTRATE100041
0406-8725-15METHADOSESUGAR-FREE15000 mL in 1 BOTTLE, PLASTICCONCENTRATE1500041

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0406-8725-10ML - Milliliter0406-872580fb6dae-1e94-4769-9021-80fefc07fb9d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHADONE HYDROCHLORIDEACTIVE INGREDIENT229809935BMETHADOSE (METHADONE HYDROCHLORIDE) CONCENTRATE METHADOSE SUGAR-FREE (METHADONE HYDROCHLORIDE) CONCENTRATE [MALLINCKRODT, INC.]11
METHADONEACTIVE MOIETYUC6VBE7V1ZMETHADOSE (METHADONE HYDROCHLORIDE) CONCENTRATE METHADOSE SUGAR-FREE (METHADONE HYDROCHLORIDE) CONCENTRATE [MALLINCKRODT, INC.]11
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLMETHADOSE (METHADONE HYDROCHLORIDE) CONCENTRATE METHADOSE SUGAR-FREE (METHADONE HYDROCHLORIDE) CONCENTRATE [MALLINCKRODT, INC.]11
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LMETHADOSE (METHADONE HYDROCHLORIDE) CONCENTRATE METHADOSE SUGAR-FREE (METHADONE HYDROCHLORIDE) CONCENTRATE [MALLINCKRODT, INC.]11
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMETHADOSE (METHADONE HYDROCHLORIDE) CONCENTRATE METHADOSE SUGAR-FREE (METHADONE HYDROCHLORIDE) CONCENTRATE [MALLINCKRODT, INC.]11
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TMETHADOSE (METHADONE HYDROCHLORIDE) CONCENTRATE METHADOSE SUGAR-FREE (METHADONE HYDROCHLORIDE) CONCENTRATE [MALLINCKRODT, INC.]11
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2METHADOSE (METHADONE HYDROCHLORIDE) CONCENTRATE METHADOSE SUGAR-FREE (METHADONE HYDROCHLORIDE) CONCENTRATE [MALLINCKRODT, INC.]11
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3METHADOSE (METHADONE HYDROCHLORIDE) CONCENTRATE METHADOSE SUGAR-FREE (METHADONE HYDROCHLORIDE) CONCENTRATE [MALLINCKRODT, INC.]11
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHMETHADOSE (METHADONE HYDROCHLORIDE) CONCENTRATE METHADOSE SUGAR-FREE (METHADONE HYDROCHLORIDE) CONCENTRATE [MALLINCKRODT, INC.]11
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUMETHADOSE (METHADONE HYDROCHLORIDE) CONCENTRATE METHADOSE SUGAR-FREE (METHADONE HYDROCHLORIDE) CONCENTRATE [MALLINCKRODT, INC.]11
SUCROSEINACTIVE INGREDIENTC151H8M554METHADOSE (METHADONE HYDROCHLORIDE) CONCENTRATE METHADOSE SUGAR-FREE (METHADONE HYDROCHLORIDE) CONCENTRATE [MALLINCKRODT, INC.]11
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KMETHADOSE (METHADONE HYDROCHLORIDE) CONCENTRATE METHADOSE SUGAR-FREE (METHADONE HYDROCHLORIDE) CONCENTRATE [MALLINCKRODT, INC.]11
WATERINACTIVE INGREDIENT059QF0KO0RMETHADOSE (METHADONE HYDROCHLORIDE) CONCENTRATE METHADOSE SUGAR-FREE (METHADONE HYDROCHLORIDE) CONCENTRATE [MALLINCKRODT, INC.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0406-8725METHADOSE (METHADONE HYDROCHLORIDE) CONCENTRATE METHADOSE SUGAR-FREE (METHADONE HYDROCHLORIDE) CONCENTRATE [SPECGX LLC]39Current NDC, Legacy NDC, 2 package rows20241006_808a9d0b-720b-4034-a862-5122ff514608.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991147methadone HCl 10 MG in 1 mL Concentrate for Oral SolutionPSN808a9d0b-720b-4034-a862-5122ff51460841
991149Methadose 10 MG in 1 mL Concentrate for Oral SolutionPSN808a9d0b-720b-4034-a862-5122ff51460841
991149methadone hydrochloride 10 MG/ML Oral Solution [Methadose]SBD808a9d0b-720b-4034-a862-5122ff51460841
991147methadone hydrochloride 10 MG/ML Oral SolutionSCD808a9d0b-720b-4034-a862-5122ff51460841
991147methadone hydrochloride 10 MG per 1 ML Oral SolutionSY808a9d0b-720b-4034-a862-5122ff51460841
991147methadone hydrochloride 5 MG per 0.5 ML Oral SolutionSY808a9d0b-720b-4034-a862-5122ff51460841
991149Methadose 10 MG per 1 ML Concentrate for Oral SolutionSY808a9d0b-720b-4034-a862-5122ff51460841

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0406-8725-10004068725101000 mL in 1 BOTTLE, PLASTIC (0406-8725-10) 1000 ml1973-03-140000-00-00NoNoCurrent
0406-8725-150040687251515000 mL in 1 BOTTLE, PLASTIC (0406-8725-15) 15000 ml1973-03-140000-00-00NoNoCurrent