FDA.reportPublic FDA data

METHADOSE

Product NDC
17856-0527
11-digit product format
178560527
Labeler code
17856
Product ID
17856-0527_660c087f-6994-408d-b868-936382b2f52f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methadone hydrochloride
Dosage form
CONCENTRATE
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
NDA017116
Marketing category
NDA
Marketing start
2010-03-10
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
17856-0527-12026-01-29C16284748780-1f386c649-be6a-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
17856-0527-22026-01-29C16284748780-1f386c649-be6a-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
17856-0527-32026-01-29C16284748780-1f386c649-be6a-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
17856-0527-12024-07-24C16284748780-1f386c649-be6a-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
17856-0527-22024-07-24C16284748780-1f386c649-be6a-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
17856-0527-32024-07-24C16284748780-1f386c649-be6a-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
17856-0527-12023-01-30C16284748780-1f386c649-be6a-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
17856-0527-22023-01-30C16284748780-1f386c649-be6a-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
17856-0527-32023-01-30C16284748780-1f386c649-be6a-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
17856-0527-1METHADOSE.5 mL in 1 SYRINGECONCENTRATE.58
17856-0527-2METHADOSE72 in 1 BOXCONCENTRATE728
17856-0527-2METHADOSE5 mL in 1 CUPCONCENTRATE58
17856-0527-3METHADOSE72 in 1 BOX, UNIT-DOSECONCENTRATE728
17856-0527-3METHADOSE2.5 mL in 1 CUP, UNIT-DOSECONCENTRATE2.58

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0527-1EA - Each17856-052740bdac12-2221-452d-9d4f-364f5111115212018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0527METHADOSE (METHADONE HYDROCHLORIDE) CONCENTRATE [ATLANTIC BIOLOGICALS CORP.]8Legacy NDC, 5 package rows20240725_4c796a39-d87f-4358-9d4b-26e27464b642.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991147methadone HCl 10 MG in 1 mL Concentrate for Oral SolutionPSN4c796a39-d87f-4358-9d4b-26e27464b6428
991149Methadose 10 MG in 1 mL Concentrate for Oral SolutionPSN4c796a39-d87f-4358-9d4b-26e27464b6428
991149methadone hydrochloride 10 MG/ML Oral Solution [Methadose]SBD4c796a39-d87f-4358-9d4b-26e27464b6428
991147methadone hydrochloride 10 MG/ML Oral SolutionSCD4c796a39-d87f-4358-9d4b-26e27464b6428
991147methadone hydrochloride 10 MG per 1 ML Oral SolutionSY4c796a39-d87f-4358-9d4b-26e27464b6428
991147methadone hydrochloride 5 MG per 0.5 ML Oral SolutionSY4c796a39-d87f-4358-9d4b-26e27464b6428
991149Methadose 10 MG per 1 ML Concentrate for Oral SolutionSY4c796a39-d87f-4358-9d4b-26e27464b6428

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0527-117856052701.5 mL in 1 SYRINGE (17856-0527-1) 2021-01-260000-00-00NoNoCurrent
17856-0527-21785605270272 CUP in 1 BOX (17856-0527-2) > 5 mL in 1 CUP72 cup2021-01-260000-00-00NoNoCurrent
17856-0527-31785605270372 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0527-3) > 2.5 mL in 1 CUP, UNIT-DOSE2021-04-120000-00-00NoNoCurrent