FDA.reportPublic FDA data

NDC 67296-2228-01 - 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
67296-2228
Requested NDC
67296-2228-01
Package NDCs from labels
67296-2228-3, 67296-2228-1, 67296-2228-01
Manufacturer
Redpharm Drug
Effective date
2026-04-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Buprenorphine and Naloxone - Redpharm DrugRedpharm Drug2026-04-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-2228-1Buprenorphine and Naloxone6 in 1 CARTONFILM61
67296-2228-1Buprenorphine and Naloxone1 in 1 POUCHFILM11
67296-2228-3Buprenorphine and Naloxone1 in 1 POUCHFILM11
67296-2228-3Buprenorphine and Naloxone30 in 1 CARTONFILM301

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 4 of 17 · 334 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NARCANNALOXONE HYDROCHLORIDE NASALSportpharm LLC3d43b2a2-9cc3-4c14-8ae7-fea4c83a7f922026-04-24WarningsExact identifier
unii: F850569PQR
buprenorphine hydrochloride and naloxone hydrochloride dihydrateBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEGolden State Medical Supply, Inc.4f6e0056-b19d-0d0e-e063-6294a90a16e52026-04-24Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONERedpharm Drug5005a6c8-9a3b-a99a-e063-6294a90aac132026-04-22Warnings, Adverse reactionsExact identifier
application number: ANDA212756
ndc (package): 67296-2228-1
ndc (package): 67296-2228-3
ndc (product): 67296-2228
ndc11 (package): 67296222801
rxcui: 1010600
spl id: 5005a983-ae58-d64e-e063-6294a90a2615
spl set id: 5005a6c8-9a3b-a99a-e063-6294a90aac13
unii: F850569PQR
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEBryant Ranch Prepack63aaa6cc-8574-4990-8239-6fdeffce92c82026-04-16Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEUnit Dose Solutions, Inc.4f979409-f9a2-d3a2-e063-6394a90accd02026-04-16Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
CLENPIQSODIUM PICOSULFATE, MAGNESIUM OXIDE, AND ANHYDROUS CITRIC ACIDFerring Pharmaceuticals Inc.e95fff66-4ec0-4001-a727-33e66a5ec7d52026-04-15Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEAveva Drug Delivery Systems Inc.cb112448-49a1-4209-bcdb-7cfae6501f512026-04-07Warnings, Adverse reactionsExact identifier
application number: ANDA212756
rxcui: 1307056
rxcui: 1307061
rxcui: 1010604
rxcui: 1010600
unii: F850569PQR
unii: 56W8MW3EN1
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDChartwell Governmental & Specialty RX, LLC58c24504-47de-487a-ab8d-18add155ea952026-04-07Adverse reactionsExact identifier
unii: 1Q73Q2JULR
BUPRENORPHINEBUPRENORPHINEBryant Ranch Prepackcd0a90c6-32cc-4114-8573-86ac85503bdf2026-04-03Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine HCl and Naloxone HClBUPRENORPHINE AND NALOXONEBryant Ranch Prepack2aaad1a7-a0fd-4dd5-bb53-03afad8f10b92026-04-03Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEBluePoint Laboratories327004b0-560a-84d0-e063-6294a90aa7432026-04-02WarningsExact identifier
unii: F850569PQR
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEINGENUS PHARMACEUTICALS, LLC4951ec29-609b-4836-b0e4-0d9c1d6ae6fe2026-03-23Warnings, Adverse reactionsExact identifier
application number: ANDA212756
ndc (product): 50742-397
rxcui: 1307056
rxcui: 1307061
rxcui: 1010604
rxcui: 1010600
spl id: 4db0df39-ce1f-bb08-e063-6294a90a3a4a
spl set id: 4951ec29-609b-4836-b0e4-0d9c1d6ae6fe
unii: F850569PQR
unii: 56W8MW3EN1
Buprenorphine HClBUPRENORPHINE HCLREMEDYREPACK INC.69a647c0-bc09-4ee2-aeb3-ef286caf25e52026-03-23Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHF Acquisition Co. LLC. DBA HealthFirst4d66b96a-acbb-2292-e063-6294a90af7882026-03-19Warnings, Adverse reactionsExact identifier
unii: F850569PQR
buprenorphine hydrochloride and naloxone hydrochloride dihydrateBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEClinical Solutions Wholesale, LLC99a5b62f-bc08-44f4-abb8-300520d2162a2026-03-06Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATEBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEClinical Solutions Wholesale, LLC8f2b94dc-f42f-45d5-8274-9e748ec20ef02026-03-05Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
REZENOPYNALOXONE HCLScienture LLC5bb502aa-014f-4a36-8972-42a9439168fe2026-03-03Warnings, Adverse reactionsExact identifier
unii: F850569PQR
buprenorphine hydrochloride and naloxone hydrochloride dihydrateBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEMajor Pharmaceuticalsc5fbec69-e7de-44a8-b9fa-0378ae61a9fe2026-03-03Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHenry Schein, Incbd65e3fe-cd7a-4855-8f55-8cc3a0921ccc2026-03-02Warnings, Adverse reactionsExact identifier
unii: F850569PQR
buprenorphine hydrochlorideBUPRENORPHINE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma442831cf-9636-433a-9a12-e9a8cd31f72a2026-02-28Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1

Reported adverse events (FAERS/openFDA)#

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