FDA.reportPublic FDA data

METHADOSE

Product NDC
17856-0526
11-digit product format
178560526
Labeler code
17856
Product ID
17856-0526_2c39cae3-ef02-463e-93be-c9f9c44bf257
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methadone hydrochloride
Dosage form
CONCENTRATE
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
NDA017116
Marketing category
NDA
Marketing start
2019-05-14
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
00dcb24c-d95e-78f6-6c1b-4d7b709bb2b9Product name620200708
a6a96832-f31d-b458-45cb-abb8bd940b44Product name220200304

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0526-12026-01-29C16284748780-1f386c649-adba-0266-e053-dadaa90a7c1aMETHADOSE ™ Oral Concentrate (methadone hydrochloride oral concentrate USP) and METHADOSE ™ Sugar-Free Oral Concentrate (methadone hydrochloride oral concentrate USP) dye-free, sugar-free, unflavored CII Rx only FOR ORAL USE ONLY
17856-0526-22026-01-29C16284748780-1f386c649-adba-0266-e053-dadaa90a7c1aMETHADOSE ™ Oral Concentrate (methadone hydrochloride oral concentrate USP) and METHADOSE ™ Sugar-Free Oral Concentrate (methadone hydrochloride oral concentrate USP) dye-free, sugar-free, unflavored CII Rx only FOR ORAL USE ONLY
17856-0526-12024-05-24C16284748780-1f386c649-adba-0266-e053-dadaa90a7c1aMETHADOSE ™ Oral Concentrate (methadone hydrochloride oral concentrate USP) and METHADOSE ™ Sugar-Free Oral Concentrate (methadone hydrochloride oral concentrate USP) dye-free, sugar-free, unflavored CII Rx only FOR ORAL USE ONLY
17856-0526-22024-05-24C16284748780-1f386c649-adba-0266-e053-dadaa90a7c1aMETHADOSE ™ Oral Concentrate (methadone hydrochloride oral concentrate USP) and METHADOSE ™ Sugar-Free Oral Concentrate (methadone hydrochloride oral concentrate USP) dye-free, sugar-free, unflavored CII Rx only FOR ORAL USE ONLY
17856-0526-12023-01-30C16284748780-1f386c649-adba-0266-e053-dadaa90a7c1aMETHADOSE ™ Oral Concentrate (methadone hydrochloride oral concentrate USP) and METHADOSE ™ Sugar-Free Oral Concentrate (methadone hydrochloride oral concentrate USP) dye-free, sugar-free, unflavored CII Rx only FOR ORAL USE ONLY
17856-0526-22023-01-30C16284748780-1f386c649-adba-0266-e053-dadaa90a7c1aMETHADOSE ™ Oral Concentrate (methadone hydrochloride oral concentrate USP) and METHADOSE ™ Sugar-Free Oral Concentrate (methadone hydrochloride oral concentrate USP) dye-free, sugar-free, unflavored CII Rx only FOR ORAL USE ONLY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0526-1METHADOSE60 in 1 BOX, UNIT-DOSECONCENTRATE603
17856-0526-1METHADOSE0.5 mL in 1 SYRINGECONCENTRATE0.53
17856-0526-2METHADOSE60 in 1 BOX, UNIT-DOSECONCENTRATE603
17856-0526-2METHADOSE1 mL in 1 SYRINGECONCENTRATE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0526METHADOSE (METHADONE HYDROCHLORIDE) CONCENTRATE [ATLANTIC BIOLOGICALS CORP.]3Legacy NDC, 4 package rows20240526_db600aee-4d27-4df4-82b5-3034c335c240.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991147methadone HCl 10 MG in 1 mL Concentrate for Oral SolutionPSNdb600aee-4d27-4df4-82b5-3034c335c2403
991149Methadose 10 MG in 1 mL Concentrate for Oral SolutionPSNdb600aee-4d27-4df4-82b5-3034c335c2403
991149methadone hydrochloride 10 MG/ML Oral Solution [Methadose]SBDdb600aee-4d27-4df4-82b5-3034c335c2403
991147methadone hydrochloride 10 MG/ML Oral SolutionSCDdb600aee-4d27-4df4-82b5-3034c335c2403
991147methadone hydrochloride 10 MG per 1 ML Oral SolutionSYdb600aee-4d27-4df4-82b5-3034c335c2403
991147methadone hydrochloride 5 MG per 0.5 ML Oral SolutionSYdb600aee-4d27-4df4-82b5-3034c335c2403
991149Methadose 10 MG per 1 ML Concentrate for Oral SolutionSYdb600aee-4d27-4df4-82b5-3034c335c2403

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0526-11785605260160 SYRINGE in 1 BOX, UNIT-DOSE (17856-0526-1) > .5 mL in 1 SYRINGE60 syringe2021-01-220000-00-00NoNoCurrent
17856-0526-21785605260260 SYRINGE in 1 BOX, UNIT-DOSE (17856-0526-2) > 1 mL in 1 SYRINGE60 syringe2021-01-220000-00-00NoNoCurrent