FDA.reportPublic FDA data

NDC 72162-1345-07 - BUPRENORPHINE

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
72162-1345
Requested NDC
72162-1345-07
Package NDCs from labels
72162-1345-3, 72162-1345-2, 72162-1345-4, 72162-1345-5, 72162-1345-6, 72162-1345-7, 72162-1345-8, 72162-1345-9, 72162-1345-0, 72162-1345-07
Manufacturer
Bryant Ranch Prepack
Effective date
2026-06-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
BUPRENORPHINE - Bryant Ranch PrepackBryant Ranch Prepack2026-06-16HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-1345-3BUPRENORPHINE30 in 1 BOTTLETABLET30107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1345BUPRENORPHINE TABLET [BRYANT RANCH PREPACK]106Current NDC, 1 package rows20250221_966adb01-71b4-4e0b-bbc6-b83da9987aa2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1345-3EA - Each72162-1345b3c3bb61-c919-4e64-b0dd-82054df3414212024-02-14

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 2 of 12 · 235 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BUPRENORPHINEBUPRENORPHINEBryant Ranch Prepack966adb01-71b4-4e0b-bbc6-b83da9987aa22026-06-16Warnings, Adverse reactionsExact identifier
application number: ANDA207276
ndc (package): 72162-1345-5
ndc (package): 72162-1345-6
ndc (package): 72162-1345-8
ndc (package): 72162-1345-4
ndc (package): 72162-1345-0
ndc (package): 72162-1345-2
ndc (package): 72162-1345-9
ndc (package): 72162-1345-3
ndc (package): 72162-1345-7
ndc (product): 72162-1345
ndc11 (package): 72162134507
rxcui: 351265
spl id: 510785c6-1456-4a79-a4a2-7e8eec746bbd
spl set id: 966adb01-71b4-4e0b-bbc6-b83da9987aa2
unii: 56W8MW3EN1
BuprenorphineBUPRENORPHINEMajor Pharmaceuticalsdba586f9-e3f2-4b9c-849b-907c81a5a0ef2026-06-16Warnings, Adverse reactionsExact identifier
rxcui: 351265
rxcui: 351264
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEBryant Ranch Prepackfe023dbf-e165-4b7f-a211-bd14696f1e2c2026-06-16Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEBryant Ranch Prepack4b1df792-f56c-4c0c-92b0-a887f42255672026-06-16Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
unii: XF417D3PSL
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd.395aec48-198a-4aed-8e38-7accfb3232f92026-06-15Warnings, Adverse reactionsExact identifier
unii: B22547B95K
Buprenorphine and Naloxone Sublingual FilmBUPRENORPHINE AND NALOXONERedpharm Drug541bf5be-8b2c-99bc-e063-6294a90a2f172026-06-13Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
ZubsolvBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEdenbridge Pharmaceuticals LLC.57583c1d-9c44-4503-917d-68dba7377bd12026-06-12Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEBryant Ranch Prepack17419c34-23a3-429c-8037-150f42536ec72026-06-12Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATECardinal Health 107, LLCb3d5225c-0ee4-481e-b9ec-bc5e1321096d2026-06-12Adverse reactionsExact identifier
unii: XF417D3PSL
Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATESpecGx LLC62abde41-46cb-4e90-a798-23d6531bf9aa2026-06-10Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine HCl and Naloxone HClBUPRENORPHINE AND NALOXONEBryant Ranch Prepacke82e2d74-33a8-4894-82f6-788fc0f9feec2026-06-08Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine HClBUPRENORPHINE HCLSpecGx LLCb60d514d-a88a-4fa2-a5b0-30ac29e049732026-06-05Warnings, Adverse reactionsExact identifier
rxcui: 351265
rxcui: 351264
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEBryant Ranch Prepackdd3bfccd-86a1-413f-affd-187f81dd07aa2026-06-03Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEBryant Ranch Prepackdd6e4fc9-a6f7-458a-b075-d736ce8b71722026-06-03Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
BUPRENORPHINEBUPRENORPHINEBryant Ranch Prepackbc5a7137-9e8f-438e-84d9-bdbf1db129982026-06-03Warnings, Adverse reactionsExact identifier
application number: ANDA207276
rxcui: 351264
unii: 56W8MW3EN1
BuprenorphineBUPRENORPHINEActavis Pharma, Inc.03819118-86f6-4329-adaf-4599e7b71f462026-05-25Warnings, Adverse reactionsExact identifier
rxcui: 351265
rxcui: 351264
unii: 56W8MW3EN1
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATESelect Consumer Group3ca80d74-1e8b-49d9-e063-6394a90a43122026-05-24WarningsExact identifier
unii: XF417D3PSL
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEREMEDYREPACK INC.072b2c2e-a564-4bb4-8954-9349a79238072026-05-22Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd8e255bc7-a120-460a-a32d-43931f8115de2026-05-21Warnings, Adverse reactionsExact identifier
unii: B22547B95K

Reported adverse events (FAERS/openFDA)#

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