FDA.reportPublic FDA data

Methadone Hydrochloride

Product NDC
66689-711
11-digit product format
666890711
Labeler code
66689
Product ID
66689-711_ba15b069-82f1-4008-8f78-5d657918b3ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methadone Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
VistaPharm, LLC
Application
ANDA090707
Marketing category
ANDA
Marketing start
2010-08-01
Substance
METHADONE HYDROCHLORIDE
Active strength
5 mg/5mL
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/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii229809935B
Rxcui864761

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bc6c52c8-e3e2-9042-21d0-6770dcf1a49bProduct name320250819
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
a48f0261-b6cc-12b3-49fd-ed131bc5aa96Product name420210902
00dcb24c-d95e-78f6-6c1b-4d7b709bb2b9Product name620200708
a6a96832-f31d-b458-45cb-abb8bd940b44Product name220200304
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66689-711-162024-01-30C16284748780-11030e365-2270-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. Methadone Hydrochloride Oral Solution, for oral use, CII Initial U.S. Approval: 1947

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66689-711-05Methadone Hydrochloride5 mL in 1 CUP, UNIT-DOSESOLUTION532
66689-711-30Methadone Hydrochloride10 in 1 TRAYSOLUTION1032
66689-711-30Methadone Hydrochloride3 in 1 CASESOLUTION332

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66689-711-05ML - Milliliter66689-71107184543-ecdc-41b6-b255-c4916c3bb99112026-04-20
66689-711-16ML - Milliliter66689-7117cc15fa6-5b6c-47fa-944e-fa0bf36c906f12012-07-24
66689-711-30ML - Milliliter66689-7117bb89519-d379-4471-bac9-fbafcc98ad7212026-04-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Methadone HydrochlorideACTIVE INGREDIENT229809935BMETHADONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC]5
MethadoneACTIVE MOIETYUC6VBE7V1ZMETHADONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC]5
AlcoholINACTIVE INGREDIENT3K9958V90MMETHADONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC]5
Anhydrous Citric AcidINACTIVE INGREDIENTXF417D3PSLMETHADONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC]5
Benzoic AcidINACTIVE INGREDIENT8SKN0B0MIMMETHADONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC]5
D&C Red No. 33INACTIVE INGREDIENT9DBA0SBB0LMETHADONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC]5
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOAMETHADONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC]5
GlycerinINACTIVE INGREDIENTPDC6A3C0OXMETHADONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC]5
SorbitolINACTIVE INGREDIENT506T60A25RMETHADONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC]5
WaterINACTIVE INGREDIENT059QF0KO0RMETHADONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66689-711METHADONE HYDROCHLORIDE SOLUTION [VISTAPHARM, LLC]28Current NDC, Legacy NDC, 3 package rows20240712_7ff89589-149c-4007-8144-5f60131b8c33.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
864761methadone HCl 5 MG in 5 mL Oral SolutionPSN7ff89589-149c-4007-8144-5f60131b8c3332
864761methadone hydrochloride 1 MG/ML Oral SolutionSCD7ff89589-149c-4007-8144-5f60131b8c3332
864761methadone HCl 5 MG per 5 ML Oral SolutionSY7ff89589-149c-4007-8144-5f60131b8c3332

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66689-711-05666890711055 mL in 1 CUP, UNIT-DOSE5 mlHistorical
66689-711-1666689071116500 mL in 1 BOTTLE (66689-711-16) 500 ml2010-08-010000-00-00NoNoCurrent
66689-711-30666890711303 TRAY in 1 CASE (66689-711-30) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (66689-711-05) 3 tray2026-03-20NoNoHistorical