Methadone Hydrochloride

Product NDC
66689-836
11-digit product format
666890836
Labeler code
66689
Product ID
66689-836_b76dbddc-b042-47d7-a7a7-f64c7c5c5035
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methadone
Dosage form
TABLET
Route
ORAL
Labeler
VistaPharm, LLC
Application
ANDA204166
Marketing category
ANDA
Marketing start
2020-09-11
Substance
METHADONE HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii229809935B
Rxcui864706

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
66689-836-99Methadone Hydrochloride100 in 1 BOTTLE, PLASTICTABLET10017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66689-836METHADONE HYDROCHLORIDE (METHADONE) TABLET [VISTAPHARM, LLC]15Current NDC, Legacy NDC, 1 package rows20250316_4a44bde6-c348-4316-b0e0-c24b407cb823.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
864706methadone HCl 10 MG Oral TabletPSN4a44bde6-c348-4316-b0e0-c24b407cb82317
864706methadone hydrochloride 10 MG Oral TabletSCD4a44bde6-c348-4316-b0e0-c24b407cb82317

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66689-836-9966689083699100 TABLET in 1 BOTTLE, PLASTIC (66689-836-99) 100 tablet2020-09-110000-00-00NoNoCurrent