FDA.reportPublic FDA data

Methadone Hydrocloride

Product NDC
72162-1085
11-digit product format
721621085
Labeler code
72162
Product ID
72162-1085_7dbaf38c-adfb-4540-add1-cf94e2e1885d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methadone hydrochloride
Dosage form
CONCENTRATE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212093
Marketing category
ANDA
Marketing start
2020-11-02
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 Hydrocloride
Brand name suffix
dye-free, sugar-free, unflavored
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
72162-1085-2Methadone Hydrocloridedye-free, sugar-free, unflavored30 mL in 1 BOTTLE, PLASTICCONCENTRATE30104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1085-2ML - Milliliter72162-1085ea869c11-e656-4a1e-b025-bb0cac30ac4b12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1085METHADONE HYDROCLORIDE DYE-FREE, SUGAR-FREE, UNFLAVORED (METHADONE HYDROCHLORIDE) CONCENTRATE [BRYANT RANCH PREPACK]103Current NDC, 1 package rows20241122_714e5adb-bdce-4dff-99aa-4ac3a2f3a0fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991147methadone HCl 10 MG in 1 mL Concentrate for Oral SolutionPSN714e5adb-bdce-4dff-99aa-4ac3a2f3a0fe104
991147methadone hydrochloride 10 MG/ML Oral SolutionSCD714e5adb-bdce-4dff-99aa-4ac3a2f3a0fe104
991147methadone hydrochloride 10 MG per 1 ML Oral SolutionSY714e5adb-bdce-4dff-99aa-4ac3a2f3a0fe104
991147methadone hydrochloride 5 MG per 0.5 ML Oral SolutionSY714e5adb-bdce-4dff-99aa-4ac3a2f3a0fe104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1085-27216210850230 mL in 1 BOTTLE, PLASTIC (72162-1085-2) 30 ml2023-10-05NoNoHistorical