FDA.reportPublic FDA data

Methadone Hydrochloride

Product NDC
17856-0694
11-digit product format
178560694
Labeler code
17856
Product ID
17856-0694_e5e27338-af5a-4be9-a3dd-0902ae000cce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methadone Hydrochloride
Dosage form
CONCENTRATE
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA040088
Marketing category
ANDA
Marketing start
2019-08-28
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bc6c52c8-e3e2-9042-21d0-6770dcf1a49bProduct name320250819
a48f0261-b6cc-12b3-49fd-ed131bc5aa96Product name420210902
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
00dcb24c-d95e-78f6-6c1b-4d7b709bb2b9Product name620200708
a6a96832-f31d-b458-45cb-abb8bd940b44Product name220200304

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0694-12026-01-29C16284748780-1f386c649-b065-0266-e053-dadaa90a7c1aMethadone HCl Oral Concentrate
17856-0694-22026-01-29C16284748780-1f386c649-b065-0266-e053-dadaa90a7c1aMethadone HCl Oral Concentrate
17856-0694-12024-05-21C16284748780-1f386c649-b065-0266-e053-dadaa90a7c1aMethadone HCl Oral Concentrate
17856-0694-22024-05-21C16284748780-1f386c649-b065-0266-e053-dadaa90a7c1aMethadone HCl Oral Concentrate
17856-0694-12023-01-30C16284748780-1f386c649-b065-0266-e053-dadaa90a7c1aMethadone HCl Oral Concentrate
17856-0694-22023-01-30C16284748780-1f386c649-b065-0266-e053-dadaa90a7c1aMethadone HCl Oral Concentrate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0694-1Methadone Hydrochloride60 in 1 BOX, UNIT-DOSECONCENTRATE603
17856-0694-1Methadone Hydrochloride0.25 mL in 1 SYRINGECONCENTRATE0.253
17856-0694-2Methadone Hydrochloride0.5 mL in 1 SYRINGECONCENTRATE0.53
17856-0694-2Methadone Hydrochloride60 in 1 BOX, UNIT-DOSECONCENTRATE603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0694METHADONE HYDROCHLORIDE CONCENTRATE [ATLANTIC BIOLOGICALS CORP.]3Legacy NDC, 4 package rows20240522_06cc3fba-68f9-4188-a239-fbd37a9f563a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991147methadone HCl 10 MG in 1 mL Concentrate for Oral SolutionPSN06cc3fba-68f9-4188-a239-fbd37a9f563a3
991147methadone hydrochloride 10 MG/ML Oral SolutionSCD06cc3fba-68f9-4188-a239-fbd37a9f563a3
991147methadone hydrochloride 10 MG per 1 ML Oral SolutionSY06cc3fba-68f9-4188-a239-fbd37a9f563a3
991147methadone hydrochloride 5 MG per 0.5 ML Oral SolutionSY06cc3fba-68f9-4188-a239-fbd37a9f563a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0694-11785606940160 SYRINGE in 1 BOX, UNIT-DOSE (17856-0694-1) > .25 mL in 1 SYRINGE60 syringe2021-01-260000-00-00NoNoCurrent
17856-0694-21785606940260 SYRINGE in 1 BOX, UNIT-DOSE (17856-0694-2) > .5 mL in 1 SYRINGE60 syringe2021-01-260000-00-00NoNoCurrent