FDA.reportPublic FDA data

NDC 71335-1360-04 - 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
71335-1360
Requested NDC
71335-1360-04
Package NDCs from labels
71335-1360-1, 71335-1360-2, 71335-1360-3, 71335-1360-4, 71335-1360-5, 71335-1360-6, 71335-1360-7, 71335-1360-8, 71335-1360-9, 71335-1360-0, 71335-1360-04
Manufacturer
Bryant Ranch Prepack
Effective date
2023-11-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
METHADONE HYDROCHLORIDE - Bryant Ranch PrepackBryant Ranch Prepack2023-11-06HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1360-0METHADONE HYDROCHLORIDE168 in 1 BOTTLETABLET1684
71335-1360-1METHADONE HYDROCHLORIDE15 in 1 BOTTLETABLET154
71335-1360-2METHADONE HYDROCHLORIDE30 in 1 BOTTLETABLET304
71335-1360-3METHADONE HYDROCHLORIDE90 in 1 BOTTLETABLET904
71335-1360-4METHADONE HYDROCHLORIDE120 in 1 BOTTLETABLET1204
71335-1360-5METHADONE HYDROCHLORIDE180 in 1 BOTTLETABLET1804
71335-1360-6METHADONE HYDROCHLORIDE60 in 1 BOTTLETABLET604
71335-1360-7METHADONE HYDROCHLORIDE28 in 1 BOTTLETABLET284
71335-1360-8METHADONE HYDROCHLORIDE112 in 1 BOTTLETABLET1124
71335-1360-9METHADONE HYDROCHLORIDE56 in 1 BOTTLETABLET564

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1360METHADONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 10 package rows20231107_7a8635fe-6183-4cda-9029-50e4e6dd5832.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1360-3EA - Each71335-136079fed854-46f3-4fbf-81d3-5fa05d33620312022-07-06

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 3 · 42 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methadone HydrochlorideMETHADONE HYDROCHLORIDEAmerican Health Packaging540edd43-165d-4257-b989-3bccc8f54afb2026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 864706
unii: 229809935B
METHADOSE DISPERSIBLEMETHADONE HYDROCHLORIDESpecGx LLC544483e6-6f9d-4371-9e93-313e54e0ea052026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 229809935B
Methadone HydrochlorideMETHADONE HYDROCHLORIDESpecGx LLC14f7b1d8-344a-4eaa-a1bf-bc1a00c3ab582026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 229809935B
METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEMajor Pharmaceuticalsdb52fdc0-765a-4fad-a8f9-ef98c6e4b8982026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 864706
unii: 229809935B
Methadone HydrochlorideMETHADONE HYDROCHLORIDEATLANTIC BIOLOGICALS CORP.d7b30c78-c531-4dc5-9552-d68daa3210d12026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 229809935B
Methadone HydrochlorideMETHADONE HYDROCHLORIDELong Grove Pharmaceuticals, LLCf453f1b9-d46e-4be8-835d-dbeb9d98a1492026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 229809935B
Methadone HydrochlorideMETHADONE HYDROCHLORIDEBreckenridge Pharmaceutical Inc13541167-95f4-4cb9-9d7d-3c1aced5c5f62026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 229809935B
METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDESpecGx LLC5baef1bf-8bf0-429c-a4ce-1c93171f3f152026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 229809935B
METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDESpecGx LLCeddf7077-02fb-4771-9823-31984f4ff2bb2026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 864706
unii: 229809935B
METHADOSEMETHADONE HYDROCHLORIDESpecGx LLC808a9d0b-720b-4034-a862-5122ff5146082026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 229809935B
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
Methadone Hydrocloride dye-free, sugar-free, unflavoredMETHADONE HYDROCHLORIDEBryant Ranch Prepack714e5adb-bdce-4dff-99aa-4ac3a2f3a0fe2026-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 229809935B
Methadone HydrochlorideMETHADONE HYDROCHLORIDEAscend Laboratories, LLCf0366917-f745-4b01-a662-a98a7d80b4a02026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090635
rxcui: 864706
unii: 229809935B
Methadone Hydrocloride dye-free, sugar-free, unflavoredMETHADONE HYDROCHLORIDEBryant Ranch Prepackf9dad5d5-3417-4992-99ee-6550f81add6b2026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 229809935B
Methadone HydrochlorideMETHADONE HYDROCHLORIDEVistaPharm, LLC7ff89589-149c-4007-8144-5f60131b8c332026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 229809935B
Methadone HydrochlorideMETHADONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.d0e6a966-179a-45e0-8444-4c1b8523f8d22026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 229809935B
Methadone HydrochlorideMETHADONE HYDROCHLORIDEHikma Pharmaceuticals USAe72841bf-364b-49b1-8e69-7e26ddcd26572026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 229809935B
Methadone HydrochlorideMETHADONE HYDROCHLORIDEVistaPharm, LLCd5bd3e97-b3f6-4bc2-9fb7-02921be35cdb2026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 229809935B
Methadone HydrochlorideMETHADONE HYDROCHLORIDEVistaPharm, LLCc54baaee-8ea4-45f5-a5c8-bb84cf86832f2026-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 229809935B

Reported adverse events (FAERS/openFDA)#

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