FDA.reportPublic FDA data

METHADONE HYDROCHLORIDE

Product NDC
0406-5755
11-digit product format
004065755
Labeler code
0406
Product ID
0406-5755_5084c093-f783-4043-8e6f-eb747a2c1d81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METHADONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
SpecGx LLC
Application
ANDA040517
Marketing category
ANDA
Marketing start
2004-04-27
Substance
METHADONE HYDROCHLORIDE
Active strength
5 mg/1
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
METHADONE HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHADONE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii229809935B
Rxcui864706, 864718

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
0406-5755-01METHADONE HYDROCHLORIDE100 in 1 BOTTLETABLET10047
0406-5755-23METHADONE HYDROCHLORIDE1 in 1 BLISTER PACKTABLET147
0406-5755-62METHADONE HYDROCHLORIDE100 in 1 BLISTER PACKTABLET10047

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0406-5755-01EA - Each0406-57555567c6fa-b1eb-4fa4-a5e1-c4658b6401ff12012-07-24
0406-5755-23EA - Each0406-5755d4090898-b0c5-469c-a827-2d76e6f9476012013-03-03
0406-5755-62EA - Each0406-5755fae52708-81f7-4c80-b868-5dba8f16700912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHADONE HYDROCHLORIDEACTIVE INGREDIENT229809935BMETHADONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]20
METHADONEACTIVE MOIETYUC6VBE7V1ZMETHADONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]20
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETHADONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]20
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETHADONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]20
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHADONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]20
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METHADONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.]20
METHADONE HYDROCHLORIDEACTIVE INGREDIENT229809935BMETHADONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY INC.]3
METHADONEACTIVE MOIETYUC6VBE7V1ZMETHADONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETHADONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETHADONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHADONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METHADONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY INC.]3
METHADONE HYDROCHLORIDEACTIVE INGREDIENT229809935BMETHADONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
METHADONE HYDROCHLORIDEACTIVE INGREDIENT229809935BMETHADONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
METHADONEACTIVE MOIETYUC6VBE7V1ZMETHADONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
METHADONEACTIVE MOIETYUC6VBE7V1ZMETHADONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETHADONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETHADONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETHADONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETHADONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHADONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHADONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METHADONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METHADONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0406-5755METHADONE HYDROCHLORIDE TABLET [SPECGX LLC]45Current NDC, Legacy NDC, 3 package rows20240725_eddf7077-02fb-4771-9823-31984f4ff2bb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
864706methadone HCl 10 MG Oral TabletPSNeddf7077-02fb-4771-9823-31984f4ff2bb47
864718methadone HCl 5 MG Oral TabletPSNeddf7077-02fb-4771-9823-31984f4ff2bb47
864706methadone hydrochloride 10 MG Oral TabletSCDeddf7077-02fb-4771-9823-31984f4ff2bb47
864718methadone hydrochloride 5 MG Oral TabletSCDeddf7077-02fb-4771-9823-31984f4ff2bb47
864706methadone HCl 10 MG Oral TabletPSN3c926b78-999e-4d26-9498-7f1bcaf0b9923
864718methadone HCl 5 MG Oral TabletPSN3c926b78-999e-4d26-9498-7f1bcaf0b9923
864706methadone hydrochloride 10 MG Oral TabletSCD3c926b78-999e-4d26-9498-7f1bcaf0b9923
864718methadone hydrochloride 5 MG Oral TabletSCD3c926b78-999e-4d26-9498-7f1bcaf0b9923
864706methadone HCl 10 MG Oral TabletPSNa36705c4-867f-41f1-94c9-78b8b31836ce1
864706methadone HCl 10 MG Oral TabletPSNcf10ec82-1f41-45c0-b438-5ade38b5625a1
864718methadone HCl 5 MG Oral TabletPSNa36705c4-867f-41f1-94c9-78b8b31836ce1
864718methadone HCl 5 MG Oral TabletPSNcf10ec82-1f41-45c0-b438-5ade38b5625a1
864706methadone hydrochloride 10 MG Oral TabletSCDa36705c4-867f-41f1-94c9-78b8b31836ce1
864706methadone hydrochloride 10 MG Oral TabletSCDcf10ec82-1f41-45c0-b438-5ade38b5625a1
864718methadone hydrochloride 5 MG Oral TabletSCDa36705c4-867f-41f1-94c9-78b8b31836ce1
864718methadone hydrochloride 5 MG Oral TabletSCDcf10ec82-1f41-45c0-b438-5ade38b5625a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0406-5755-0100406575501100 TABLET in 1 BOTTLE (0406-5755-01) 100 tablet2004-04-270000-00-00NoNoCurrent
0406-5755-23004065755231 TABLET in 1 BLISTER PACK (0406-5755-23) 1 tablet2004-04-270000-00-00NoNoCurrent
0406-5755-6200406575562100 TABLET in 1 BLISTER PACK (0406-5755-62) 100 tablet2004-04-270000-00-00NoNoCurrent