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 6 of 13 · 259 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Glucose Drops 2031GLUCOSE DROPSProfessional Complementary Health Formulas21de3b86-be2b-4f71-9384-78ebc42ec0872026-01-08WarningsExact identifier
unii: 9G5L16BK6N
Pain Formula Drops 2046PAIN FORMULA DROPSProfessional Complementary Health Formulas4456c022-5aac-49b4-b976-b629525f3d492026-01-08WarningsExact identifier
unii: H4N855PNZ1
Herbal Diuretic Liquescence 3011HERBAL DIURETIC LIQUESCENCEProfessional Complementary Health Formulas5eee7f21-a3c4-46e0-a642-a4ca635734e32026-01-08WarningsExact identifier
unii: XF417D3PSL
BELBUCABUPRENORPHINE HYDROCHLORIDEBioDelivery Sciences International Incbc2b7a3d-72cf-497c-95b0-ba2b71f63c642026-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine and Naloxone Sublingual FilmBUPRENORPHINE AND NALOXONEAlvogen Inc.4210afeb-474c-d842-d68e-af7e0021851a2026-01-01Warnings, Adverse reactionsExact identifier
unii: 5Q187997EE
unii: 56W8MW3EN1
Buprenorphine HydrochlorideBUPRENORPHINE HYDROCHLORIDEHospira, Inc.23aa1bb3-cecf-4e62-29bb-48488bb66fc32025-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
Buprenorphine and Naloxone Sublingual FilmBUPRENORPHINE AND NALOXONERedpharm Drug2fd16916-95a9-14b5-e063-6294a90a79fa2025-12-27Warnings, Adverse reactionsExact identifier
unii: 5Q187997EE
unii: 56W8MW3EN1
ZubsolvBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEOrexo US, Inc.5f5cfcfe-d52b-49e6-8fe4-550477332dd22025-12-27Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine HClBUPRENORPHINE HCLRedpharm Drug301eaed5-8499-ad95-e063-6294a90a58f52025-12-23Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
SuboxoneBUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDEINDIVIOR INC.8a5edcf9-828c-4f97-b671-268ab13a8ecd2025-12-22Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine HydrochlorideBUPRENORPHINE HYDROCHLORIDEPar Health USA, LLC34767dda-ce52-4f98-a45f-bb5cee0cd5e62025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
NAIL TREATMENT Oil ElixirsTEA TREE OILGuangzhou Mizi Biotechnology Co., LTD.44913371-df05-05a9-e063-6294a90a5d202025-12-17WarningsExact identifier
unii: H4N855PNZ1
HZ-ChordBAPTISIA TINCTORIA, CEANOTHUS AMERICANUS, CITRICUM ACIDUM, ECHINACEA (ANGUSTIFOLIA), GELSEMIUM SEMPERVIRENS, HYDROCOTYLE ASIATICA, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, MEZEREUM, MORBILLINUM, NUX VOMICA, PALOONDO, PHYTOLACCA DECANDRA, SEPIA, THUJA OCCIDENTALIS, THYROIDINUM (BOVINE)Energetix Corporation9685aec5-a65d-40fe-b5d7-2f13a69733bc2025-12-17WarningsExact identifier
unii: XF417D3PSL
Category VIMMUNE SYSTEM BOOSTERVitality Works, Inc,0d3dd923-336c-4ccd-a344-ec49b2e80d102025-12-17WarningsExact identifier
unii: XF417D3PSL
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONERedpharm Drug374530e2-3b2e-77d7-e063-6394a90a37c92025-12-11Warnings, Adverse reactionsExact identifier
application number: ANDA205601
ndc (package): 67296-2164-6
ndc (package): 67296-2164-1
ndc (product): 67296-2164
ndc11 (package): 67296216401
rxcui: 351267
spl id: 45abede5-7ceb-60e1-e063-6394a90a9a4a
spl set id: 374530e2-3b2e-77d7-e063-6394a90a37c9
unii: 5Q187997EE
unii: 56W8MW3EN1
FCS HPEPINEPHRINE,GLUTAMICACID,MUCUNAPRURIENSSEED,NIACINAMIDE,SEROTONIN,UBIDECARENONE,CORTICOTROPIN,ADENOSINETRIPHOSPHATE,INSULINPORK,SUSSCROFAPARATHYROIDGLAND,SUSSCROFAPITUITARYGLAND,THIAMINEHYDROCHLORIDE,THYROID,ANHYDROUSCITRICACID,HERRINGSPERMDNA,SACCHAROMYCESCEREVISIAERNA,ANACARDIUMOCCIDENTALEFRUIT,ARSENICTRIOXIDE,ASPARTICACID,BARIUMCARBONATE,OYSTERSHELLCALCIUMCARBONATECRUDE,CLEMATISRECTAFLOWERINGTOP,LYCOPODIUMCLAVATUMSPORE,ANEMONEPULSATILLA,DATURASTRAMONIUM,SULFURNatural Creations, Inc.ba8fed68-f27f-4651-adec-0994a53758872025-12-10WarningsExact identifier
unii: XF417D3PSL
FCS CPCORTICOTROPIN,GLUTAMICACID,MUCUNAPURIENSSEED,SEROTONIN,EPINEPHRINE,NIACINAMIDE,UBIDECARENONE,ADENOSINETRIPHOSPHATE,INSULINPORK,SUSSCROFAPARATHYROIDGLAND,SUSSCROFAPITUITARYGLAND,THIAMINEHYDROCHLORIDE,THYROID,UNSPECIFIED,ANHYDROUSCITRICACID,HERRINGSPERMDNA,SACCHAROMYCESCEREVISIAERNA,ANACARDIUMOCCIDENTALEFRUIT,ARSENICTRIOXIDE,ASPARTICACID,BARIUMCARBONATE,OYSTERSHELLCALCIUMCARBONATE,CRUDE,CLEMATISRECTAFLOWERINGTOP,LYCOPODIUMCLAVATUMSPORE,ANEMONEPULSATILLA,DATURASTRAMONIUM,SULFURNatural Creations, Inccb69e9d6-62a6-4af0-8d2d-1e68b0830a202025-12-10WarningsExact identifier
unii: XF417D3PSL
Alka-Seltzer Extra StrengthANHYDROUS CITRIC ACID, SODIUM BICARBONATE, AND ASPIRINBayer HealthCare LLC.49b73bd5-6465-05eb-e054-00144ff88e882025-12-04WarningsExact identifier
unii: XF417D3PSL
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATEBayer HealthCare LLC.5be36a7f-7d1f-468d-9c29-92c8cd3ef1bc2025-12-04WarningsExact identifier
unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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