FDA.reportPublic FDA data

Methadone Hydrochloride

Product NDC
17856-0392
11-digit product format
178560392
Labeler code
17856
Product ID
17856-0392_36b0bbb0-eb9e-7547-e063-6394a90a25f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methadone Hydrochloride
Dosage form
CONCENTRATE
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA040180
Marketing category
ANDA
Marketing start
2019-05-14
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0392-12024-05-20C16284748780-11030e365-6d01-111a-e063-dadaa90a10e20392 - Methadone Hydrochloride Oral Concentrate USP CII (Dye-Free, Sugar-Free, Unflavored) and Methadone Hydrochloride Oral Concentrate USP CII (Cherry) FOR ORAL USE ONLY Rx Only
17856-0392-32024-05-20C16284748780-11030e365-6d01-111a-e063-dadaa90a10e20392 - Methadone Hydrochloride Oral Concentrate USP CII (Dye-Free, Sugar-Free, Unflavored) and Methadone Hydrochloride Oral Concentrate USP CII (Cherry) FOR ORAL USE ONLY Rx Only
17856-0392-72024-05-20C16284748780-11030e365-6d01-111a-e063-dadaa90a10e20392 - Methadone Hydrochloride Oral Concentrate USP CII (Dye-Free, Sugar-Free, Unflavored) and Methadone Hydrochloride Oral Concentrate USP CII (Cherry) FOR ORAL USE ONLY Rx Only
17856-0392-12024-01-30C16284748780-11030e365-6d01-111a-e063-dadaa90a10e20392 - Methadone Hydrochloride Oral Concentrate USP CII (Dye-Free, Sugar-Free, Unflavored) and Methadone Hydrochloride Oral Concentrate USP CII (Cherry) FOR ORAL USE ONLY Rx Only
17856-0392-32024-01-30C16284748780-11030e365-6d01-111a-e063-dadaa90a10e20392 - Methadone Hydrochloride Oral Concentrate USP CII (Dye-Free, Sugar-Free, Unflavored) and Methadone Hydrochloride Oral Concentrate USP CII (Cherry) FOR ORAL USE ONLY Rx Only
17856-0392-72024-01-30C16284748780-11030e365-6d01-111a-e063-dadaa90a10e20392 - Methadone Hydrochloride Oral Concentrate USP CII (Dye-Free, Sugar-Free, Unflavored) and Methadone Hydrochloride Oral Concentrate USP CII (Cherry) FOR ORAL USE ONLY Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0392-1Methadone Hydrochloride60 in 1 BOX, UNIT-DOSECONCENTRATE606
17856-0392-1Methadone Hydrochloride0.5 mL in 1 SYRINGECONCENTRATE0.56
17856-0392-2Methadone Hydrochloride60 in 1 BOX, UNIT-DOSECONCENTRATE606
17856-0392-3Methadone Hydrochloride72 in 1 BOX, UNIT-DOSECONCENTRATE726
17856-0392-4Methadone Hydrochloride2.5 mL in 1 CUP, UNIT-DOSECONCENTRATE2.56
17856-0392-5Methadone Hydrochloride1 mL in 1 SYRINGECONCENTRATE16
17856-0392-6Methadone Hydrochloride0.5 mL in 1 SYRINGECONCENTRATE0.56
17856-0392-6Methadone Hydrochloride1 in 1 BAGCONCENTRATE16
17856-0392-7Methadone Hydrochloride5 in 1 SYRINGECONCENTRATE56
17856-0392-8Methadone Hydrochloride1 mL in 1 SYRINGECONCENTRATE16
17856-0392-8Methadone Hydrochloride1 in 1 BAGCONCENTRATE16
17856-0392-9Methadone Hydrochloride1 in 1 BAGCONCENTRATE16
17856-0392-9Methadone Hydrochloride2.5 mL in 1 SYRINGECONCENTRATE2.56

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0392METHADONE HYDROCHLORIDE CONCENTRATE [ATLANTIC BIOLOGICALS CORP.]5Current NDC, Legacy NDC, 13 package rows20240522_d7b30c78-c531-4dc5-9552-d68daa3210d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991147methadone HCl 10 MG in 1 mL Concentrate for Oral SolutionPSNd7b30c78-c531-4dc5-9552-d68daa3210d16
991147methadone hydrochloride 10 MG/ML Oral SolutionSCDd7b30c78-c531-4dc5-9552-d68daa3210d16
991147methadone hydrochloride 10 MG per 1 ML Oral SolutionSYd7b30c78-c531-4dc5-9552-d68daa3210d16
991147methadone hydrochloride 5 MG per 0.5 ML Oral SolutionSYd7b30c78-c531-4dc5-9552-d68daa3210d16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0392-11785603920160 SYRINGE in 1 BOX, UNIT-DOSE (17856-0392-1) / .5 mL in 1 SYRINGE60 syringe2024-05-200000-00-00NoNoCurrent
17856-0392-21785603920260 SYRINGE in 1 BOX, UNIT-DOSE (17856-0392-2) > 1 mL in 1 SYRINGE60 syringe2021-01-180000-00-00NoNoCurrent
17856-0392-31785603920372 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0392-3) / 2.5 mL in 1 CUP, UNIT-DOSE (17856-0392-4) 2024-05-200000-00-00NoNoCurrent
17856-0392-4178560392042.5 mL in 1 CUP, UNIT-DOSE2.5 mlHistorical
17856-0392-5178560392051 mL in 1 SYRINGE1 mlHistorical
17856-0392-6178560392061 SYRINGE in 1 BAG (17856-0392-6) / .5 mL in 1 SYRINGE1 syringe2025-05-30NoNoCurrent
17856-0392-7178560392075 BOX, UNIT-DOSE in 1 SYRINGE (17856-0392-7) / 60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0392-2) / 1 mL in 1 SYRINGE (17856-0392-5) 2024-05-200000-00-00NoNoCurrent
17856-0392-8178560392081 SYRINGE in 1 BAG (17856-0392-8) / 1 mL in 1 SYRINGE1 syringe2025-05-30NoNoCurrent
17856-0392-9178560392091 SYRINGE in 1 BAG (17856-0392-9) / 2.5 mL in 1 SYRINGE1 syringe2025-05-30NoNoCurrent