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 5 of 15 · 288 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEUnit Dose Solutions, Inc.4b301ad7-ac0e-f849-e063-6394a90a27d52026-02-19Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
BuprenorphineBUPRENORPHINESun Pharmaceutical Industries, Inc.9fd1f18f-0b0f-4059-b603-19ecbf0ed63a2026-02-11Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONESun Pharmaceutical Industries, Inc.91b68606-05de-4586-ae31-07e8cc9160cf2026-02-10Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
BUPRENORPHINEBUPRENORPHINEA-S Medication Solutionsbfb02ea5-22f2-432e-afc8-f1dbe2ea06142026-02-06Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEActavis Pharma, Inc.6cccf229-9611-4b6f-8f1b-acc8ff1ed3f82026-02-06Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine HCl and Naloxone HClBUPRENORPHINE AND NALOXONEAmneal Pharmaceuticals LLC17b63f10-c9df-44be-80fa-6f1c305583b82026-02-02Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONECamber Pharmaceuticals, Inc.221195e4-de08-414c-af08-a611a74789de2026-01-30Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONECamber Pharmaceuticals, Inc.5ab2d4e4-3c8c-413a-b147-23eafbde313a2026-01-28Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
BuprenorphineBUPRENORPHINEHikma Pharmaceuticals USA Inc.1bf8b35a-b769-465c-a2f8-099868dfcd2f2026-01-24Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATEBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATERedpharm Drug44f2e26f-4586-5204-e063-6394a90a47d52026-01-23Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine HClBUPRENORPHINE HCLCamber Pharmaceuticals, Inc.b52cea0e-688f-4beb-bf7d-f228b81dbd232026-01-23Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEMylan Pharmaceuticals Inc.557d8d4d-8751-431c-b18e-9d5cf23fc5792026-01-15Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEDr.Reddys Laboratories Inc718756d7-0131-b173-6c45-5ee039b311b02026-01-12Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEDr.Reddys Laboratories Inc72dc1ec0-7c59-a587-4ffd-c40ef79e6fb22026-01-12Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Endotoxin Terrain Drops 2143ENDOTOXIN TERRAIN DROPSProfessional Complementary Health Formulas58842566-005a-48b5-973d-20cde2fbd7012026-01-08WarningsExact identifier
unii: QTT17582CB
BuprenorphineBUPRENORPHINEAvPAK1408cd8f-a0b5-6be7-e063-6394a90a0b412026-01-08Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine HCl and Naloxone HClBUPRENORPHINE AND NALOXONEAvPAKb955054b-b37d-4079-4fed-5939b763ecb42026-01-08Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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