FDA.reportPublic FDA data

NDC 67296-2164-01 - Buprenorphine and Naloxone

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
67296-2164
Requested NDC
67296-2164-01
Package NDCs from labels
67296-2164-6, 67296-2164-1, 67296-2164-01
Manufacturer
Redpharm Drug
Effective date
2025-12-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CORN SYRUP - Redpharm DrugRedpharm Drug2025-12-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-2164-1Buprenorphine and Naloxone12 in 1 BOTTLE, PLASTICTABLET123
67296-2164-6Buprenorphine and Naloxone6 in 1 BOTTLE, PLASTICTABLET63

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 8 of 13 · 259 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
InterSolPLATELET ADDITIVE 3Fenwal, Inc.17dec820-1b57-4ac9-82a8-419cab664a2f2025-06-27Warnings, Adverse reactionsExact identifier
unii: B22547B95K
Nauzene Chewables Ginger HoneySODIUM CITRATEKobayashi Healthcare International, Inc.25c9825d-a4e8-4671-e063-6294a90ab46d2025-06-24WarningsExact identifier
unii: B22547B95K
buprenorphine hydrochlorideBUPRENORPHINE HYDROCHLORIDEA-S Medication Solutionsc1398d85-d4bb-4426-8ecf-a50400910d812025-05-28Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
MannitolMANNITOLHenry Schein, Inc.e2444db1-9dfe-451f-a33c-9b00786464d22025-05-20Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
NauzeneSODIUM CITRATEKobayashi Healthcare International, Inc.a60660b2-c5db-45a0-885f-de93e655380d2025-04-29WarningsExact identifier
unii: B22547B95K
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDKesin Pharma Corporation3140f8fe-0644-7561-e063-6394a90a2c282025-04-21Adverse reactionsExact identifier
unii: XF417D3PSL
Bio Co Enzyme PhaseACONITICUM ACIDUM, CIS-, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ADRENALINUM, , ALPHA-KETOGLUTARICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, ASCORBICUM ACIDUM, BARIUM OXALSUCCINICUM, BETA VULGARIS, CERIUM OXALICUM, CITRICUM ACIDUM, CYSTEINUM, FUMARICUM ACIDUM, HEPAR SULPHURIS CALCAREUM, MAGNESIUM OROTICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM PHOSPHORICUM, NADIDUM, NATRUM OXALACETICUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PANTOTHENIC ACID, PROTEUS (MORGANI), PULSATILLA (PRATENSIS), PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM,Deseret Biologicals, Inc.6edee6eb-0ec9-4d2a-9dc9-dc2a6503a6db2025-04-08WarningsExact identifier
unii: XF417D3PSL
St. Paul Brands VerestorVITAMIN C,VITAMIN E,NATTOKINASE,PHYTOSTEROL,DOKUDAMI LEAF,RUTIN,BETA-CAROTENEAdvanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals0e0b6c75-0ae8-4ef4-ab86-0f3be5ca63d12025-03-31WarningsExact identifier
unii: H4N855PNZ1
Buprenorphine HClBUPRENORPHINE HCLBryant Ranch Prepackd5a8c41e-413e-4d48-9739-d158e5681dd02025-03-28Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Vitafol OnePRENATAL SUPPLEMENT WITH DHAExeltis USA, Inc.42a5cafd-a2c0-4ac2-99c9-708642f007162025-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: H4N855PNZ1
Buprenorphine HydrochlorideBUPRENORPHINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.adc1167e-910e-4d7b-abdc-751d3df0c3dc2025-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Aspartame/MSG DetoxCHELIDONIUM MAJUS, ARNICA MONTANA, PHYTOLACCA DECANDRA, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, BISPHENOL A (BPA), DEXTROSE, MALTODEXTRIN, SUCRALOSE, ASPARTIC ACID, DIKETOPIPERAZINE, DOPAMINE HYDROCHLORIDE, FORMALINUM, FORMICUM ACIDUM, L-PHENYLALANINE, METHYL ALCOHOL, MONOSODIUM GLUTAMATEDeseret Biologicals, Inc.a1dc1bf3-db71-4550-a975-4f146fb940052025-03-11WarningsExact identifier
unii: 7CVR7L4A2D
BuprenorphineBUPRENORPHINEClinical Solutions Wholesale, LLC9d976ee7-9509-49da-89fd-48d7e712697b2025-02-17Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine HydrochlorideBUPRENORPHINE HYDROCHLORIDESomerset Therapeutics, LLC74e40c51-853b-4e7f-b3cb-a27af29e1cbf2025-02-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
BuprenorphineBUPRENORPHINEClinical Solutions Wholesale, LLC023c7816-21b1-4f85-be36-9e32d5935c192025-02-03Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Progena ImmugenARALIA QUINQUEFOLIA, ECHINACEA, PHYTOLACCA DECANDRA, ASCORBIC ACID, BETA CAROTENE, GLANDULA SUPRARENALIS, PYRIDOXINUM HYDROCHLORICUM, SPLEEN, THYMUS, SELENIUM METALLICUM, VITAMIN E, ZINCUM METALLICUMMeditrend, Inc. DBA Progena Professional Formulations6df039e8-b6e8-489f-87de-af71efd1f7b72025-01-29WarningsExact identifier
unii: H4N855PNZ1
Sodium Citrate w/v AnticoagulantTRISODIUM CITRATE DIHYDRATETerumo BCT, Ltdc9d0e9c8-379f-4895-b272-329efab575c42025-01-24Warnings, Adverse reactionsExact identifier
unii: B22547B95K
Sodium Citrate 4% w/v AnticoagulantTRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd0775912f-f14a-4967-ac00-c8c1b36040bf2025-01-23Warnings, Adverse reactionsExact identifier
unii: B22547B95K
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAvPAKfe070e2e-3e72-fb84-e053-6294a90afd882025-01-09Adverse reactionsExact identifier
unii: XF417D3PSL
Emetrol Powder Non-DrowsySODIUM CITRATE DIHYDRATEWellSpring Pharmaceutical Corporation9d8d2ee7-9db7-4be7-8c73-511eb2e324592025-01-08WarningsExact identifier
unii: B22547B95K

Reported adverse events (FAERS/openFDA)#

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