FDA.reportPublic FDA data

NDC 17856-0392-4 - Methadone Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
17856-0392
Requested NDC
17856-0392-4
Package NDCs from labels
17856-0392-1, 17856-0392-5, 17856-0392-2, 17856-0392-7, 17856-0392-4, 17856-0392-3, 17856-0392-6, 17856-0392-8, 17856-0392-9
Manufacturer
ATLANTIC BIOLOGICALS CORP.
Effective date
2026-07-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Methadone Hydrochloride - ATLANTIC BIOLOGICALS CORP.ATLANTIC BIOLOGICALS CORP.2026-07-10HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
17856-0392-12024-05-200392 - Methadone Hydrochloride Oral Concentrate USP CII (Dye-Free, Sugar-Free, Unflavored) and Methadone Hydrochloride Oral Concentrate USP CII (Cherry) FOR ORAL USE ONLY Rx Only
17856-0392-12024-05-200392 - Methadone Hydrochloride Oral Concentrate USP CII (Dye-Free, Sugar-Free, Unflavored) and Methadone Hydrochloride Oral Concentrate USP CII (Cherry) FOR ORAL USE ONLY Rx Only
17856-0392-32024-05-200392 - Methadone Hydrochloride Oral Concentrate USP CII (Dye-Free, Sugar-Free, Unflavored) and Methadone Hydrochloride Oral Concentrate USP CII (Cherry) FOR ORAL USE ONLY Rx Only
17856-0392-32024-05-200392 - Methadone Hydrochloride Oral Concentrate USP CII (Dye-Free, Sugar-Free, Unflavored) and Methadone Hydrochloride Oral Concentrate USP CII (Cherry) FOR ORAL USE ONLY Rx Only
17856-0392-72024-05-200392 - Methadone Hydrochloride Oral Concentrate USP CII (Dye-Free, Sugar-Free, Unflavored) and Methadone Hydrochloride Oral Concentrate USP CII (Cherry) FOR ORAL USE ONLY Rx Only
17856-0392-72024-05-200392 - Methadone Hydrochloride Oral Concentrate USP CII (Dye-Free, Sugar-Free, Unflavored) and Methadone Hydrochloride Oral Concentrate USP CII (Cherry) FOR ORAL USE ONLY Rx Only
17856-0392-12024-01-300392 - Methadone Hydrochloride Oral Concentrate USP CII (Dye-Free, Sugar-Free, Unflavored) and Methadone Hydrochloride Oral Concentrate USP CII (Cherry) FOR ORAL USE ONLY Rx Only
17856-0392-12024-01-300392 - Methadone Hydrochloride Oral Concentrate USP CII (Dye-Free, Sugar-Free, Unflavored) and Methadone Hydrochloride Oral Concentrate USP CII (Cherry) FOR ORAL USE ONLY Rx Only
17856-0392-32024-01-300392 - Methadone Hydrochloride Oral Concentrate USP CII (Dye-Free, Sugar-Free, Unflavored) and Methadone Hydrochloride Oral Concentrate USP CII (Cherry) FOR ORAL USE ONLY Rx Only
17856-0392-32024-01-300392 - Methadone Hydrochloride Oral Concentrate USP CII (Dye-Free, Sugar-Free, Unflavored) and Methadone Hydrochloride Oral Concentrate USP CII (Cherry) FOR ORAL USE ONLY Rx Only
17856-0392-72024-01-300392 - Methadone Hydrochloride Oral Concentrate USP CII (Dye-Free, Sugar-Free, Unflavored) and Methadone Hydrochloride Oral Concentrate USP CII (Cherry) FOR ORAL USE ONLY Rx Only
17856-0392-72024-01-300392 - Methadone Hydrochloride Oral Concentrate USP CII (Dye-Free, Sugar-Free, Unflavored) and Methadone Hydrochloride Oral Concentrate USP CII (Cherry) FOR ORAL USE ONLY Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0392-1Methadone Hydrochloride60 in 1 BOX, UNIT-DOSECONCENTRATE606
17856-0392-1Methadone Hydrochloride0.5 mL in 1 SYRINGECONCENTRATE0.56
17856-0392-2Methadone Hydrochloride60 in 1 BOX, UNIT-DOSECONCENTRATE606
17856-0392-3Methadone Hydrochloride72 in 1 BOX, UNIT-DOSECONCENTRATE726
17856-0392-4Methadone Hydrochloride2.5 mL in 1 CUP, UNIT-DOSECONCENTRATE2.56
17856-0392-5Methadone Hydrochloride1 mL in 1 SYRINGECONCENTRATE16
17856-0392-6Methadone Hydrochloride0.5 mL in 1 SYRINGECONCENTRATE0.56
17856-0392-6Methadone Hydrochloride1 in 1 BAGCONCENTRATE16
17856-0392-7Methadone Hydrochloride5 in 1 SYRINGECONCENTRATE56
17856-0392-8Methadone Hydrochloride1 mL in 1 SYRINGECONCENTRATE16
17856-0392-8Methadone Hydrochloride1 in 1 BAGCONCENTRATE16
17856-0392-9Methadone Hydrochloride1 in 1 BAGCONCENTRATE16
17856-0392-9Methadone Hydrochloride2.5 mL in 1 SYRINGECONCENTRATE2.56

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0392METHADONE HYDROCHLORIDE CONCENTRATE [ATLANTIC BIOLOGICALS CORP.]5Current NDC, Legacy NDC, 13 package rows20240522_d7b30c78-c531-4dc5-9552-d68daa3210d1.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 38 · 742 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methadone HydrochlorideMETHADONE HYDROCHLORIDESpecGx LLC14f7b1d8-344a-4eaa-a1bf-bc1a00c3ab582026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 991147
unii: 229809935B
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
Topwin Speedy EnemaGLYCERINHealth Chemical Pharmaceutical Co., Ltd3ba8c3d2-1780-42e1-bec5-8f98771d475e2026-07-27WarningsExact identifier
unii: PDC6A3C0OX
NeutraflushEYEWASH STATION ADDITIVE CONCENTRATEAero Healthcare1d9ff2ef-9c9b-f367-e063-6294a90afa0e2026-07-24WarningsExact identifier
unii: 6DC9Q167V3
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: PDC6A3C0OX
XenletaLEFAMULIN ACETATEMeitheal Pharmaceuticals Inc.eb972ea8-7502-422e-84bb-66cb8e93ca062026-07-22Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLGlobal Equipment Companybc93a1e8-aa3c-6735-e053-2995a90ad6e82026-07-16WarningsExact identifier
unii: 6DC9Q167V3
Revitalize Energizing Eye DropsNAPHAZOLINE HYDROCHLORIDE ,PROPYLENE GLYCOLRevitalize Energy Inc.518aac87-1642-4b2f-bca1-b74d21261eea2026-07-16WarningsExact identifier
unii: 6DC9Q167V3
METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEMajor Pharmaceuticalsdb52fdc0-765a-4fad-a8f9-ef98c6e4b8982026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 229809935B
Methadone HydrochlorideMETHADONE HYDROCHLORIDEATLANTIC BIOLOGICALS CORP.d7b30c78-c531-4dc5-9552-d68daa3210d12026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040180
ndc (package): 17856-0392-6
ndc (package): 17856-0392-5
ndc (package): 17856-0392-7
ndc (package): 17856-0392-4
ndc (package): 17856-0392-1
ndc (package): 17856-0392-8
ndc (package): 17856-0392-2
ndc (package): 17856-0392-3
ndc (package): 17856-0392-9
ndc (product): 17856-0392
ndc11 (package): 17856039204
rxcui: 991147
spl id: 56433232-5399-e119-e063-6294a90a66db
spl set id: d7b30c78-c531-4dc5-9552-d68daa3210d1
unii: 229809935B
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: PDC6A3C0OX
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: PDC6A3C0OX
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd552d9018-cc7d-7e1a-e063-6294a90a33222026-06-26WarningsExact identifier
unii: PDC6A3C0OX