Methadone Hydrochloride

Product NDC
17856-3553
11-digit product format
178563553
Labeler code
17856
Product ID
17856-3553_37459ca8-3b45-473b-89bb-a6543da55493
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methadone Hydrochloride
Dosage form
CONCENTRATE
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA089897
Marketing category
ANDA
Marketing start
2018-10-31
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
2019-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-3553-1Methadone Hydrochloride60 in 1 BOX, UNIT-DOSECONCENTRATE601
17856-3553-1Methadone Hydrochloride1 mL in 1 SYRINGECONCENTRATE11
17856-3553-2Methadone Hydrochloride0.5 mL in 1 SYRINGECONCENTRATE0.51
17856-3553-2Methadone Hydrochloride60 in 1 BOX, UNIT-DOSECONCENTRATE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-3553METHADONE HYDROCHLORIDE CONCENTRATE [ATLANTIC BIOLOGICALS CORP.]1Legacy NDC, 4 package rows20181101_52bea06c-6c93-4458-a79b-c3eb3a9166b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991147methadone HCl 10 MG in 1 mL Concentrate for Oral SolutionPSN52bea06c-6c93-4458-a79b-c3eb3a9166b61
991147methadone hydrochloride 10 MG/ML Oral SolutionSCD52bea06c-6c93-4458-a79b-c3eb3a9166b61
991147methadone hydrochloride 10 MG per 1 ML Oral SolutionSY52bea06c-6c93-4458-a79b-c3eb3a9166b61
991147methadone hydrochloride 5 MG per 0.5 ML Oral SolutionSY52bea06c-6c93-4458-a79b-c3eb3a9166b61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
17856-3553-11785635530160 in 1 BOX, UNIT-DOSEHistorical
17856-3553-2178563553020.5 mL in 1 SYRINGE0.5 mlHistorical