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 6 of 15 · 288 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
Cell Energy Performance Drops 2048CELL ENERGY PERFORMANCE DROPSProfessional Complementary Health Formulas8701ea61-5d5f-466b-8d2c-f808e7b4d8fe2026-01-08WarningsExact identifier
unii: 5SL0G7R0OK
Abdominal Pain Drops 2051ABDOMINAL PAIN DROPSProfessional Complementary Health Formulasf1b1dde6-bb37-4774-a58c-b4f648f9c2b52026-01-08WarningsExact identifier
unii: QTT17582CB
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: 56W8MW3EN1
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
unii: 059QF0KO0R
Buprenorphine HydrochlorideBUPRENORPHINE HYDROCHLORIDEHospira, Inc.23aa1bb3-cecf-4e62-29bb-48488bb66fc32025-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
teeth and gumsCALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOSSiddha Flower Essences LLC926c79d5-d270-4c0d-aca9-b58571c24f3a2025-12-31WarningsExact identifier
unii: 059QF0KO0R
lung and sinusCALC PHOS, FERRUM PHOS, GENTIANELLA AMARELLA, FLOS, KALI MUR, KALI PHOS, KALI SULPH, ROCK WATER, ROSE CANINA, FLOSSiddha Flower Essences LLC9f7c949f-21bc-473c-ab8d-24837893fccc2025-12-31WarningsExact identifier
unii: 059QF0KO0R
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsExact identifier
unii: 059QF0KO0R
Rite Aid Eye WashPURIFIED WATERRite Aid28a18e04-d735-a511-e063-6394a90af6bb2025-12-30WarningsExact identifier
unii: 059QF0KO0R
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsExact identifier
unii: 059QF0KO0R
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
unii: 059QF0KO0R
Buprenorphine and Naloxone Sublingual FilmBUPRENORPHINE AND NALOXONERedpharm Drug2fd16916-95a9-14b5-e063-6294a90a79fa2025-12-27Warnings, Adverse reactionsExact identifier
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
rxcui: 238129
unii: 56W8MW3EN1
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
HemorrhoidAESCULUS HIPP, HAMAMELIS, ALOE, CALC PHOS, CARBO AN, CARBO VEG, LACHESIS, LYCOPODIUM, MURIATICUM AC, NITRICUM AC, NUX VOM, PAEONIA, RATANHIA, SEPIA, SULPHURNatural Creations, Incdb1b3aef-ba92-417c-b6f6-58e950ed42142025-12-16WarningsExact identifier
unii: QTT17582CB

Reported adverse events (FAERS/openFDA)#

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