FDA.reportPublic FDA data

Methadone Hydrochloride

Product NDC
0054-3555
11-digit product format
000543555
Labeler code
0054
Product ID
0054-3555_02c36c8d-ac85-4274-bf54-532c83f57396
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methadone Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA087393
Marketing category
ANDA
Marketing start
1981-05-22
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, 864769

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0054-3555-63Methadone Hydrochloride500 mL in 1 BOTTLESOLUTION50023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-3555-63ML - Milliliter0054-35551ed14a04-a048-4d51-b75a-166fac2f392812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHADONE HYDROCHLORIDEACTIVE INGREDIENT229809935BMETHADONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.]5
METHADONEACTIVE MOIETYUC6VBE7V1ZMETHADONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.]5
ALCOHOLINACTIVE INGREDIENT3K9958V90MMETHADONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.]5
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLMETHADONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.]5
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMMETHADONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMETHADONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8METHADONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMETHADONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.]5
SORBITOLINACTIVE INGREDIENT506T60A25RMETHADONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.]5
METHADONE HYDROCHLORIDEACTIVE INGREDIENT229809935BMETHADONE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
METHADONEACTIVE MOIETYUC6VBE7V1ZMETHADONE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MMETHADONE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLMETHADONE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMMETHADONE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMETHADONE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8METHADONE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMETHADONE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
SORBITOLINACTIVE INGREDIENT506T60A25RMETHADONE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-3555METHADONE HYDROCHLORIDE SOLUTION [HIKMA PHARMACEUTICALS USA INC.]20Current NDC, Legacy NDC, 1 package rows20240619_8c363f90-c378-48ae-abbc-aeb25c9bf5cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
864769methadone HCl 10 MG in 5 mL Oral SolutionPSN8c363f90-c378-48ae-abbc-aeb25c9bf5cb23
864761methadone HCl 5 MG in 5 mL Oral SolutionPSN8c363f90-c378-48ae-abbc-aeb25c9bf5cb23
864761methadone hydrochloride 1 MG/ML Oral SolutionSCD8c363f90-c378-48ae-abbc-aeb25c9bf5cb23
864769methadone hydrochloride 2 MG/ML Oral SolutionSCD8c363f90-c378-48ae-abbc-aeb25c9bf5cb23
864761methadone HCl 5 MG per 5 ML Oral SolutionSY8c363f90-c378-48ae-abbc-aeb25c9bf5cb23
864769methadone hydrochloride 10 MG per 5 ML Oral SolutionSY8c363f90-c378-48ae-abbc-aeb25c9bf5cb23
864769methadone HCl 10 MG in 5 mL Oral SolutionPSNc3c1b3f7-3bb1-4864-b634-8fc9dbaac9bb15
864761methadone HCl 5 MG in 5 mL Oral SolutionPSNc3c1b3f7-3bb1-4864-b634-8fc9dbaac9bb15
864761methadone hydrochloride 1 MG/ML Oral SolutionSCDc3c1b3f7-3bb1-4864-b634-8fc9dbaac9bb15
864769methadone hydrochloride 2 MG/ML Oral SolutionSCDc3c1b3f7-3bb1-4864-b634-8fc9dbaac9bb15
864761methadone HCl 5 MG per 5 ML Oral SolutionSYc3c1b3f7-3bb1-4864-b634-8fc9dbaac9bb15
864769methadone hydrochloride 10 MG per 5 ML Oral SolutionSYc3c1b3f7-3bb1-4864-b634-8fc9dbaac9bb15
864761methadone HCl 5 MG in 5 mL Oral SolutionPSNcbc42334-8783-4572-b8da-8c7451d140775
864761methadone HCl 5 MG in 5 mL Oral SolutionPSNeff99966-a35c-4952-a9aa-1344da90b9eb5
864761methadone hydrochloride 1 MG/ML Oral SolutionSCDcbc42334-8783-4572-b8da-8c7451d140775
864761methadone hydrochloride 1 MG/ML Oral SolutionSCDeff99966-a35c-4952-a9aa-1344da90b9eb5
864761methadone HCl 5 MG per 5 ML Oral SolutionSYeff99966-a35c-4952-a9aa-1344da90b9eb5
864761methadone HCl 5 MG per 5 ML Oral SolutionSYcbc42334-8783-4572-b8da-8c7451d140775
864761methadone HCl 5 MG in 5 mL Oral SolutionPSNf935effe-e5b2-4bf7-bbde-6e80bb99076f3
864761methadone hydrochloride 1 MG/ML Oral SolutionSCDf935effe-e5b2-4bf7-bbde-6e80bb99076f3
864761methadone HCl 5 MG per 5 ML Oral SolutionSYf935effe-e5b2-4bf7-bbde-6e80bb99076f3
864761methadone HCl 5 MG in 5 mL Oral SolutionPSNe980d666-d74d-4358-a3b7-c6accb15eba62
864761methadone hydrochloride 1 MG/ML Oral SolutionSCDe980d666-d74d-4358-a3b7-c6accb15eba62
864761methadone HCl 5 MG per 5 ML Oral SolutionSYe980d666-d74d-4358-a3b7-c6accb15eba62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-3555-6300054355563500 mL in 1 BOTTLE (0054-3555-63) 500 ml1981-05-220000-00-00NoNoCurrent