FDA.reportPublic FDA data

METHADOSE DISPERSIBLE

Product NDC
0406-0540
11-digit product format
004060540
Labeler code
0406
Product ID
0406-0540_991d6748-896f-42c1-88d6-fe1e77275181
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methadone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
SpecGx LLC
Application
ANDA074184
Marketing category
ANDA
Marketing start
1993-04-29
Substance
METHADONE HYDROCHLORIDE
Active strength
40 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
METHADOSE DISPERSIBLE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHADONE HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii229809935B
Rxcui864978, 864980

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bc6c52c8-e3e2-9042-21d0-6770dcf1a49bProduct name320250819
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
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
0406-0540-34METHADOSE DISPERSIBLE100 in 1 BOTTLETABLET10035

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0406-0540-34EA - Each0406-0540e2c7ddbe-6153-462d-a073-d9ce2b33536412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHADONE HYDROCHLORIDEACTIVE INGREDIENT229809935BMETHADOSE DISPERSIBLE (METHADONE HYDROCHLORIDE) TABLET METHADONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]15
METHADONEACTIVE MOIETYUC6VBE7V1ZMETHADOSE DISPERSIBLE (METHADONE HYDROCHLORIDE) TABLET METHADONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]15
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933METHADOSE DISPERSIBLE (METHADONE HYDROCHLORIDE) TABLET METHADONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]15
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPMETHADOSE DISPERSIBLE (METHADONE HYDROCHLORIDE) TABLET METHADONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]15
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETHADOSE DISPERSIBLE (METHADONE HYDROCHLORIDE) TABLET METHADONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]15
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MMETHADOSE DISPERSIBLE (METHADONE HYDROCHLORIDE) TABLET METHADONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]15
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8METHADOSE DISPERSIBLE (METHADONE HYDROCHLORIDE) TABLET METHADONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHADOSE DISPERSIBLE (METHADONE HYDROCHLORIDE) TABLET METHADONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]15
POTASSIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT4J9FJ0HL51METHADOSE DISPERSIBLE (METHADONE HYDROCHLORIDE) TABLET METHADONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]15
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METHADOSE DISPERSIBLE (METHADONE HYDROCHLORIDE) TABLET METHADONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]15
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETHADOSE DISPERSIBLE (METHADONE HYDROCHLORIDE) TABLET METHADONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]15
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMETHADOSE DISPERSIBLE (METHADONE HYDROCHLORIDE) TABLET METHADONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0406-0540METHADOSE DISPERSIBLE (METHADONE HYDROCHLORIDE) TABLET METHADONE HYDROCHLORIDE TABLET [SPECGX LLC]35Current NDC, Legacy NDC, 1 package rows20240724_544483e6-6f9d-4371-9e93-313e54e0ea05.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
864978methadone HCl 40 MG Tablet for Oral SuspensionPSN544483e6-6f9d-4371-9e93-313e54e0ea0535
864980METHADOSE 40 MG Tablet for Oral SuspensionPSN544483e6-6f9d-4371-9e93-313e54e0ea0535
864980methadone hydrochloride 40 MG Tablet for Oral Suspension [Methadose]SBD544483e6-6f9d-4371-9e93-313e54e0ea0535
864978methadone hydrochloride 40 MG Tablet for Oral SuspensionSCD544483e6-6f9d-4371-9e93-313e54e0ea0535
864978methadone HCl 40 MG Tablet for Oral SuspensionSY544483e6-6f9d-4371-9e93-313e54e0ea0535
864980Methadose 40 MG Tablet for Oral SuspensionSY544483e6-6f9d-4371-9e93-313e54e0ea0535

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0406-0540-3400406054034100 TABLET in 1 BOTTLE (0406-0540-34) 100 tablet1993-04-290000-00-00NoNoCurrent