FDA.reportPublic FDA data

Methadone Hydrochloride

Product NDC
66689-898
11-digit product format
666890898
Labeler code
66689
Product ID
66689-898_9a8696a0-2dff-4277-a9a7-1a897f9a1860
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methadone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
VistaPharm, LLC
Application
ANDA075082
Marketing category
ANDA
Marketing start
1998-03-25
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
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 HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii229809935B
Rxcui864978

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
66689-898-40Methadone Hydrochloride100 in 1 BOTTLETABLET10021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66689-898-40EA - Each66689-8987461dd02-6c1b-4aa5-a200-d010edef2d6f12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHADONE HYDROCHLORIDEACTIVE INGREDIENT229809935BMETHADONE HYDROCHLORIDE TABLET [VISTAPHARM, INC.]8
METHADONEACTIVE MOIETYUC6VBE7V1ZMETHADONE HYDROCHLORIDE TABLET [VISTAPHARM, INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETHADONE HYDROCHLORIDE TABLET [VISTAPHARM, INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHADONE HYDROCHLORIDE TABLET [VISTAPHARM, INC.]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METHADONE HYDROCHLORIDE TABLET [VISTAPHARM, INC.]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETHADONE HYDROCHLORIDE TABLET [VISTAPHARM, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66689-898METHADONE HYDROCHLORIDE TABLET [VISTAPHARM, LLC]20Current NDC, Legacy NDC, 1 package rows20241102_c54baaee-8ea4-45f5-a5c8-bb84cf86832f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
864978methadone HCl 40 MG Tablet for Oral SuspensionPSNc54baaee-8ea4-45f5-a5c8-bb84cf86832f21
864978methadone hydrochloride 40 MG Tablet for Oral SuspensionSCDc54baaee-8ea4-45f5-a5c8-bb84cf86832f21
864978methadone HCl 40 MG Tablet for Oral SuspensionSYc54baaee-8ea4-45f5-a5c8-bb84cf86832f21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66689-898-4066689089840100 TABLET in 1 BOTTLE (66689-898-40) 100 tablet1998-03-250000-00-00NoNoCurrent