FDA.reportPublic FDA data

Methadone Hydrochloride

Product NDC
60687-818
11-digit product format
606870818
Labeler code
60687
Product ID
60687-818_3506271d-27f4-2065-e063-6394a90ac386
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methadone Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
American Health Packaging
Application
ANDA087393
Marketing category
ANDA
Marketing start
2024-12-16
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
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 HYDROCHLORIDE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii229809935B
Rxcui864761

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
60687-818-40Methadone Hydrochloride5 mL in 1 CUP, UNIT-DOSESOLUTION53
60687-818-46Methadone Hydrochloride10 in 1 TRAYSOLUTION103
60687-818-86Methadone Hydrochloride3 in 1 CASESOLUTION33

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-818-40ML - Milliliter60687-818baa50911-29a8-42e3-8ff8-e620abebc19812024-10-04
60687-818-46ML - Milliliter60687-81862c2bf7e-5d69-4f4d-a286-ffdc3eff70ac12025-11-13
60687-818-86ML - Milliliter60687-818ac5d0812-8708-4964-a13f-7e401f352f3412024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-818METHADONE HYDROCHLORIDE SOLUTION [AMERICAN HEALTH PACKAGING]2Current NDC, 3 package rows20241007_f935effe-e5b2-4bf7-bbde-6e80bb99076f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-818-40606870818405 mL in 1 CUP, UNIT-DOSE5 mlHistorical
60687-818-466068708184610 in 1 TRAYHistorical
60687-818-86606870818863 TRAY in 1 CASE (60687-818-86) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-818-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-818-40) 3 tray2024-12-16NoNoHistorical