Methadone Hydrochloride

Product NDC
66689-695
11-digit product format
666890695
Labeler code
66689
Product ID
66689-695_a139d04a-25e0-499f-8bfb-43328f560410
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methadone Hydrochloride
Dosage form
CONCENTRATE
Route
ORAL
Labeler
VistaPharm, LLC
Application
ANDA040088
Marketing category
ANDA
Marketing start
2017-03-29
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
Methadone Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHADONE HYDROCHLORIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii229809935B
Rxcui991147

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
66689-695-79Methadone Hydrochloride1000 mL in 1 BOTTLECONCENTRATE100024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66689-695-79ML - Milliliter66689-695b49752fb-71b1-479f-bda8-9337af31bdec12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66689-695METHADONE HYDROCHLORIDE CONCENTRATE [VISTAPHARM, LLC]22Current NDC, Legacy NDC, 1 package rows20250126_d5bd3e97-b3f6-4bc2-9fb7-02921be35cdb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991147methadone HCl 10 MG in 1 mL Concentrate for Oral SolutionPSNd5bd3e97-b3f6-4bc2-9fb7-02921be35cdb24
991147methadone hydrochloride 10 MG/ML Oral SolutionSCDd5bd3e97-b3f6-4bc2-9fb7-02921be35cdb24
991147methadone hydrochloride 10 MG per 1 ML Oral SolutionSYd5bd3e97-b3f6-4bc2-9fb7-02921be35cdb24
991147methadone hydrochloride 5 MG per 0.5 ML Oral SolutionSYd5bd3e97-b3f6-4bc2-9fb7-02921be35cdb24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66689-695-306668906953030 mL in 1 BOTTLE, DROPPER (66689-695-30) 30 ml2017-03-290000-00-00NoNoCurrent
66689-695-79666890695791000 mL in 1 BOTTLE (66689-695-79) 1000 ml2017-03-290000-00-00NoNoCurrent