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 7 of 37 · 737 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
Methadone HydrochlorideMETHADONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.d0e6a966-179a-45e0-8444-4c1b8523f8d22026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 991147
unii: 229809935B
Artificial TearsGLYCERINPreferred Pharmaceuticals Inc.dd646c72-8f47-43c6-a734-db0dcc8cd4d12026-03-06WarningsExact identifier
unii: PDC6A3C0OX
Dry Eye Relief Sterile Lubricant Eye DropsGLYCERINSimilasan Corporation4c4cce1c-392e-354d-e063-6294a90a0ca32026-03-05WarningsExact identifier
unii: PDC6A3C0OX
Methadone HydrochlorideMETHADONE HYDROCHLORIDEHikma Pharmaceuticals USAe72841bf-364b-49b1-8e69-7e26ddcd26572026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040180
ndc (product): 0054-0392
rxcui: 991147
spl id: 6cc1b9b7-bfbc-478b-a572-05a802018bda
spl set id: e72841bf-364b-49b1-8e69-7e26ddcd2657
unii: 229809935B
Sore ThroatPHENOL GLYCERINCVS PHARMACY, INC9683bcfb-2f7e-48a4-aa79-500ee8df099a2026-03-02WarningsExact identifier
unii: PDC6A3C0OX
Refresh Optive Mega-3 PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.326cb5d6-c784-404f-9a13-6d69262dda6e2026-03-01WarningsExact identifier
unii: PDC6A3C0OX
Dermatool HemorrhoidalGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLPapalo Group LLC4bc06f41-7733-ebd0-e063-6294a90af7a82026-02-26WarningsExact identifier
unii: PDC6A3C0OX
Kidnex IVGINKGO BILOBA, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALICUM ACIDUM, PYRUVIC ACID, SUCCINICUM ACIDUM, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, GERMANIUM SESQUIOXIDE, MERCURIUS VIVUS, NUX VOMICA, KIDNEY (SUIS), LYMPH NODE (SUIS), NAPHTHOCHINONUM, NATRUM OXALACETICUM, PHOSPHORUS, URINARY BLADDER (SUIS), ACONITICUM ACIDUM, CIS-Energique, Inc.23de6b8e-7622-4ba6-89f7-37bd151687e22026-02-26WarningsExact identifier
unii: XF417D3PSL
Leader Extra Strength Effervescent Antacid and Pain RelieverASPIRIN, CITRIC ACID, SODIUM BICARBONATECardinal Healthc5d7bf5f-3e59-52f2-e053-2a95a90a4a002026-02-25WarningsExact identifier
unii: XF417D3PSL
Mitochondria ProARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM,Energique, Inc.2f365207-b730-428d-9465-8853e86e79ff2026-02-18WarningsExact identifier
unii: XF417D3PSL
Methadone HydrochlorideMETHADONE HYDROCHLORIDEVistaPharm, LLCd5bd3e97-b3f6-4bc2-9fb7-02921be35cdb2026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 991147
unii: 229809935B
WowDay Hemorrhoid and Fissure CreamHEMORRHOID AND FISSURE CREAMWowDay LLC47ba86ad-240a-e733-e063-6394a90a24e32026-02-12WarningsExact identifier
unii: PDC6A3C0OX
Viva Hydration BoostGLYCERINNomax Inc174193b2-65eb-b5fd-e063-6394a90a9cd02026-02-10WarningsExact identifier
unii: PDC6A3C0OX
Droptics Performance Eye DropsNAPHAZOLINE HYDROCHLORIDE, PROPYLENE GLYCOLDroptics LLC20fd6822-a7fd-4593-92bb-0a07260893e22026-02-09WarningsExact identifier
unii: 6DC9Q167V3
OptaseGLYCERINScope Health Inc376e0289-28e9-e87f-e063-6294a90a3b042026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Inc10c3e31d-779d-8ff6-e063-6294a90acd392026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Inc9e96976b-2990-79e0-e053-2995a90a0f292026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Incd81c1a4f-87b0-ee8c-e053-2995a90af9e52026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Incf452a2c4-c869-7bf5-e053-2995a90ac1a02026-01-30WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.