Methadone Hydrochloride

Product NDC
17478-380
11-digit product format
174780380
Labeler code
17478
Product ID
17478-380_3f104296-cbe9-4e21-999c-fec45759ae73
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methadone Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Akorn
Application
ANDA208306
Marketing category
ANDA
Marketing start
2017-10-30
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
2023-12-31
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
17478-380-202024-01-30C16284748780-11030e365-6b12-111a-e063-dadaa90a10e2Methadone Hydrochloride Injection, USP CII 200 mg/20 mL (10 mg/mL)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17478-380-20Methadone Hydrochloride20 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION209

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-380-20ML - Milliliter17478-38095bb9f7a-e7e1-446f-897e-747e237b03a712017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17478-380METHADONE HYDROCHLORIDE INJECTION, SOLUTION [AKORN ]9Legacy NDC, 1 package rows20221208_cedfe8fa-b57d-4cb1-a047-0af5a8ef199e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
864714methadone HCl 10 MG/ML Injectable SolutionPSNcedfe8fa-b57d-4cb1-a047-0af5a8ef199e9
864714methadone hydrochloride 10 MG/ML Injectable SolutionSCDcedfe8fa-b57d-4cb1-a047-0af5a8ef199e9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17478-380-201747803802020 mL in 1 VIAL, MULTI-DOSE (17478-380-20) 20 ml2017-10-300000-00-00NoNoCurrent