FDA.reportPublic FDA data

NDC 0143-9246-01 - Buprenorphine 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
0143-9246
Requested NDC
0143-9246-01
Package NDCs from labels
0143-9246-01, 0143-9246-05
Manufacturer
Hikma Pharmaceuticals USA Inc.
Effective date
2025-03-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Buprenorphine Hydrochloride - Hikma Pharmaceuticals USA Inc.Hikma Pharmaceuticals USA Inc.2025-03-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9246-01Buprenorphine Hydrochloride1 mL in 1 VIALINJECTION18
0143-9246-05Buprenorphine Hydrochloride5 in 1 CARTONINJECTION58

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9246BUPRENORPHINE HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.]8Current NDC, Legacy NDC, 2 package rows20250316_adc1167e-910e-4d7b-abdc-751d3df0c3dc.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9246-01ML - Milliliter0143-9246613f41eb-c021-4951-b4fe-320d3d1f309b12020-05-08
0143-9246-05ML - Milliliter0143-9246a50f3db0-965d-44ec-b772-cb19503e744612020-05-08

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 15 · 288 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BUPRENORPHINEBUPRENORPHINEUnit Dose Solutions, Inc.5578cd5c-c860-6e8a-e063-6394a90a56c72026-06-30Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
BUPRENORPHINEBUPRENORPHINEBryant Ranch Prepackaa132031-9d12-45b4-81e0-4a58776613792026-06-29Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
BuprenorphineBUPRENORPHINEBryant Ranch Prepack655e3e52-03be-496c-978a-5cffc74b2ae42026-06-29Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
BUPRENORPHINE AND NALOXONEBUPRENORPHINE AND NALOXONEAscend Laboratories, LLC2e807ed0-6df3-47b5-b7ee-b421c5bf0aa72026-06-29Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
BUPRENORPHINEBUPRENORPHINEUnit Dose Solutions, Inc.5479b218-a388-2c3c-e063-6294a90a0e852026-06-17Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BUPRENORPHINEBUPRENORPHINEBryant Ranch Prepack966adb01-71b4-4e0b-bbc6-b83da9987aa22026-06-16Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
BuprenorphineBUPRENORPHINEMajor Pharmaceuticalsdba586f9-e3f2-4b9c-849b-907c81a5a0ef2026-06-16Warnings, Adverse reactionsExact identifier
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
Buprenorphine and Naloxone Sublingual FilmBUPRENORPHINE AND NALOXONERedpharm Drug541bf5be-8b2c-99bc-e063-6294a90a2f172026-06-13Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDTotal Operations Management LLC DBA:Bestmade Natural Products Micro5423bde6-3e31-38b0-e063-6294a90afb2d2026-06-13WarningsExact identifier
unii: QTT17582CB
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDBM Private Limited540d11e3-e4a1-0ca2-e063-6394a90a3c262026-06-12WarningsExact identifier
unii: QTT17582CB
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBTotal Operations Management LLC DBA:Bestmade Natural Products Micro54113d1f-e8e7-6b4c-e063-6394a90a0edf2026-06-12WarningsExact identifier
unii: 059QF0KO0R
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

Reported adverse events (FAERS/openFDA)#

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