FDA.reportPublic FDA data

Methadone Hydrochloride

Product NDC
70166-284
11-digit product format
701660284
Labeler code
70166
Product ID
70166-284_923a3dd2-b856-f053-e053-2995a90a8204
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methadone Hydrochloride
Dosage form
CONCENTRATE
Route
ORAL
Labeler
Lohxa
Application
ANDA089897
Marketing category
ANDA
Marketing start
1988-04-30
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
2020-12-31
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
70166-284-012023-01-30C16284748780-1f386c649-bd74-0266-e053-dadaa90a7c1aMethadone Hydrochloride Oral Concentrate USP CII, 10 mg per mL (Dye-Free, Sugar-Free, Unflavored)
70166-284-022023-01-30C16284748780-1f386c649-bd74-0266-e053-dadaa90a7c1aMethadone Hydrochloride Oral Concentrate USP CII, 10 mg per mL (Dye-Free, Sugar-Free, Unflavored)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70166-284-01Methadone Hydrochloride30 in 1 BOXCONCENTRATE302
70166-284-01Methadone Hydrochloride1 in 1 BAGCONCENTRATE12
70166-284-02Methadone Hydrochloride1 in 1 BAGCONCENTRATE12
70166-284-02Methadone Hydrochloride30 in 1 BOXCONCENTRATE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70166-284METHADONE HYDROCHLORIDE CONCENTRATE [LOHXA]2Legacy NDC, 4 package rows20190911_9804a4b6-51cd-40f8-84eb-e9655b50ee04.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991147methadone HCl 10 MG in 1 mL Concentrate for Oral SolutionPSN9804a4b6-51cd-40f8-84eb-e9655b50ee042
991147methadone hydrochloride 10 MG/ML Oral SolutionSCD9804a4b6-51cd-40f8-84eb-e9655b50ee042
991147methadone hydrochloride 10 MG per 1 ML Oral SolutionSY9804a4b6-51cd-40f8-84eb-e9655b50ee042
991147methadone hydrochloride 5 MG per 0.5 ML Oral SolutionSY9804a4b6-51cd-40f8-84eb-e9655b50ee042

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70166-284-017016602840130 BAG in 1 BOX (70166-284-01) > 1 SYRINGE in 1 BAG > 1 mL in 1 SYRINGE30 bag2018-02-220000-00-00NoNoCurrent
70166-284-027016602840230 BAG in 1 BOX (70166-284-02) > 1 SYRINGE in 1 BAG > 5 mL in 1 SYRINGE30 bag2018-02-220000-00-00NoNoCurrent