FDA.reportPublic FDA data

Methadone Hydrochloride

Product NDC
17856-3555
11-digit product format
178563555
Labeler code
17856
Product ID
17856-3555_eee58a0e-2c67-428b-9f8b-effa9888d0a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methadone Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA087393
Marketing category
ANDA
Marketing start
1981-05-22
Marketing end
0000-00-00
Substance
METHADONE HYDROCHLORIDE
Active strength
5 mg/5mL
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bc6c52c8-e3e2-9042-21d0-6770dcf1a49bProduct name320250819
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
a48f0261-b6cc-12b3-49fd-ed131bc5aa96Product name420210902
00dcb24c-d95e-78f6-6c1b-4d7b709bb2b9Product name620200708
a6a96832-f31d-b458-45cb-abb8bd940b44Product name220200304
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-3555-12025-01-30C16284748780-19d75b9cf-ec1e-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1947
17856-3555-22025-01-30C16284748780-19d75b9cf-ec1e-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1947
17856-3555-42025-01-30C16284748780-19d75b9cf-ec1e-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1947
17856-3555-52025-01-30C16284748780-19d75b9cf-ec1e-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1947
17856-3555-82025-01-30C16284748780-19d75b9cf-ec1e-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1947
17856-3555-12023-11-02C16284748780-19d75b9cf-ec1e-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1947
17856-3555-22023-11-02C16284748780-19d75b9cf-ec1e-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1947
17856-3555-42023-11-02C16284748780-19d75b9cf-ec1e-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1947
17856-3555-52023-11-02C16284748780-19d75b9cf-ec1e-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1947
17856-3555-82023-11-02C16284748780-19d75b9cf-ec1e-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1947
17856-3555-12022-01-28C16284748780-19d75b9cf-ec1e-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1947
17856-3555-22022-01-28C16284748780-19d75b9cf-ec1e-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1947
17856-3555-42022-01-28C16284748780-19d75b9cf-ec1e-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1947
17856-3555-52022-01-28C16284748780-19d75b9cf-ec1e-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1947
17856-3555-82022-01-28C16284748780-19d75b9cf-ec1e-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1947
17856-3555-12020-04-28C16284748780-19d75b9cf-ec1e-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1947
17856-3555-22020-04-28C16284748780-19d75b9cf-ec1e-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1947
17856-3555-52020-04-28C16284748780-19d75b9cf-ec1e-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1947
17856-3555-12020-01-31C16284748780-19d75b9cf-ec1e-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1947
17856-3555-22020-01-31C16284748780-19d75b9cf-ec1e-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1947
17856-3555-52020-01-31C16284748780-19d75b9cf-ec1e-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use METHADONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE ORAL SOLUTION. METHADONE HYDROCHLORIDE oral solution, for oral use CII Initial U.S. Approval: 1947

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-3555-1Methadone Hydrochloride2 mL in 1 CUPSOLUTION215
17856-3555-2Methadone Hydrochloride1 mL in 1 SYRINGESOLUTION115
17856-3555-2Methadone Hydrochloride120 in 1 CASESOLUTION12015
17856-3555-4Methadone Hydrochloride60 in 1 BOX, UNIT-DOSESOLUTION6015
17856-3555-4Methadone Hydrochloride1 mL in 1 SYRINGESOLUTION115
17856-3555-5Methadone Hydrochloride5 mL in 1 CUP, UNIT-DOSESOLUTION515
17856-3555-8Methadone Hydrochloride120 in 1 BOX, UNIT-DOSESOLUTION12015
17856-3555-8Methadone Hydrochloride1 mL in 1 SYRINGESOLUTION115

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHADONE HYDROCHLORIDEACTIVE INGREDIENT229809935BMETHADONE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
METHADONEACTIVE MOIETYUC6VBE7V1ZMETHADONE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MMETHADONE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLMETHADONE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMMETHADONE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMETHADONE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8METHADONE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMETHADONE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
SORBITOLINACTIVE INGREDIENT506T60A25RMETHADONE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-3555METHADONE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORP.]15Legacy NDC, 8 package rows20231103_c3c1b3f7-3bb1-4864-b634-8fc9dbaac9bb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
864769methadone HCl 10 MG in 5 mL Oral SolutionPSNc3c1b3f7-3bb1-4864-b634-8fc9dbaac9bb15
864761methadone HCl 5 MG in 5 mL Oral SolutionPSNc3c1b3f7-3bb1-4864-b634-8fc9dbaac9bb15
864761methadone hydrochloride 1 MG/ML Oral SolutionSCDc3c1b3f7-3bb1-4864-b634-8fc9dbaac9bb15
864769methadone hydrochloride 2 MG/ML Oral SolutionSCDc3c1b3f7-3bb1-4864-b634-8fc9dbaac9bb15
864761methadone HCl 5 MG per 5 ML Oral SolutionSYc3c1b3f7-3bb1-4864-b634-8fc9dbaac9bb15
864769methadone hydrochloride 10 MG per 5 ML Oral SolutionSYc3c1b3f7-3bb1-4864-b634-8fc9dbaac9bb15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-3555-1178563555012 mL in 1 CUP (17856-3555-1) 2 ml2020-04-270000-00-00NoNoCurrent
17856-3555-217856355502120 SYRINGE in 1 CASE (17856-3555-2) > 1 mL in 1 SYRINGE120 syringe2020-04-270000-00-00NoNoCurrent
17856-3555-41785635550460 SYRINGE in 1 BOX, UNIT-DOSE (17856-3555-4) > 1 mL in 1 SYRINGE60 syringe2020-04-270000-00-00NoNoCurrent
17856-3555-5178563555055 mL in 1 CUP, UNIT-DOSE (17856-3555-5) 5 ml2020-04-270000-00-00NoNoCurrent
17856-3555-817856355508120 SYRINGE in 1 BOX, UNIT-DOSE (17856-3555-8) > 1 mL in 1 SYRINGE120 syringe2020-08-060000-00-00NoNoCurrent