FDA.reportPublic FDA data

Methadone Hydrochloride

Product NDC
0054-3553
11-digit product format
000543553
Labeler code
0054
Product ID
0054-3553_f4843a89-4cfb-40de-8399-a7449b4865e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methadone Hydrochloride
Dosage form
CONCENTRATE
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA089897
Marketing category
ANDA
Marketing start
1988-09-06
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Methadone Hydrochloride
Listing expiration
2026-12-31

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
0054-3553-44Methadone Hydrochloride30 mL in 1 BOTTLECONCENTRATE3011
0054-3553-44Methadone Hydrochloride1 in 1 CARTONCONCENTRATE111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-3553-44ML - Milliliter0054-35537f20c4b7-99db-4bd1-ae7e-a8fd16c0ce2812013-02-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHADONE HYDROCHLORIDEACTIVE INGREDIENT229809935BMETHADONE HYDROCHLORIDE CONCENTRATE [ROXANE LABORATORIES, INC]4
METHADONEACTIVE MOIETYUC6VBE7V1ZMETHADONE HYDROCHLORIDE CONCENTRATE [ROXANE LABORATORIES, INC]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPMETHADONE HYDROCHLORIDE CONCENTRATE [ROXANE LABORATORIES, INC]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUMETHADONE HYDROCHLORIDE CONCENTRATE [ROXANE LABORATORIES, INC]4
WATERINACTIVE INGREDIENT059QF0KO0RMETHADONE HYDROCHLORIDE CONCENTRATE [ROXANE LABORATORIES, INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-3553METHADONE HYDROCHLORIDE CONCENTRATE [HIKMA PHARMACEUTICALS USA INC.]11Current NDC, Legacy NDC, 2 package rows20250507_d0e6a966-179a-45e0-8444-4c1b8523f8d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991147methadone HCl 10 MG in 1 mL Concentrate for Oral SolutionPSNd0e6a966-179a-45e0-8444-4c1b8523f8d211
991147methadone hydrochloride 10 MG/ML Oral SolutionSCDd0e6a966-179a-45e0-8444-4c1b8523f8d211
991147methadone hydrochloride 10 MG per 1 ML Oral SolutionSYd0e6a966-179a-45e0-8444-4c1b8523f8d211
991147methadone hydrochloride 5 MG per 0.5 ML Oral SolutionSYd0e6a966-179a-45e0-8444-4c1b8523f8d211
991147methadone HCl 10 MG in 1 mL Concentrate for Oral SolutionPSN52bea06c-6c93-4458-a79b-c3eb3a9166b61
991147methadone hydrochloride 10 MG/ML Oral SolutionSCD52bea06c-6c93-4458-a79b-c3eb3a9166b61
991147methadone hydrochloride 10 MG per 1 ML Oral SolutionSY52bea06c-6c93-4458-a79b-c3eb3a9166b61
991147methadone hydrochloride 5 MG per 0.5 ML Oral SolutionSY52bea06c-6c93-4458-a79b-c3eb3a9166b61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-3553-44000543553441 BOTTLE in 1 CARTON (0054-3553-44) / 30 mL in 1 BOTTLE1 bottle1988-09-060000-00-00NoNoCurrent