NDC 70518-4571-01 - 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
70518-4571
Requested NDC
70518-4571-01
Package NDCs from labels
70518-4571-1, 70518-4571-0, 70518-4571-2, 70518-4571-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-07-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
buprenorphine hydrochloride - REMEDYREPACK INC.REMEDYREPACK INC.2026-07-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4571-0buprenorphine hydrochloride30 in 1 BOXTABLET301
70518-4571-1buprenorphine hydrochloride1 in 1 POUCHTABLET11

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 12 · 235 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buprenorphine HClBUPRENORPHINE HCLREMEDYREPACK INC.69a647c0-bc09-4ee2-aeb3-ef286caf25e52026-03-23Warnings, Adverse reactionsExact identifier
rxcui: 351265
unii: 56W8MW3EN1
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
buprenorphine hydrochloride and naloxone hydrochloride dihydrateBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEMajor Pharmaceuticalsc5fbec69-e7de-44a8-b9fa-0378ae61a9fe2026-03-03Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
buprenorphine hydrochlorideBUPRENORPHINE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma442831cf-9636-433a-9a12-e9a8cd31f72a2026-02-28Warnings, Adverse reactionsExact identifier
application number: ANDA090622
ndc (product): 0121-2038
rxcui: 351265
rxcui: 351264
spl id: 2b5cbeb4-82cc-4f47-a277-9b16e5dbc150
spl set id: 442831cf-9636-433a-9a12-e9a8cd31f72a
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharmad5b011ef-f1be-47f2-8f8b-07553f36193c2026-02-28Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Kidnex IVGINKGO BILOBA, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALICUM ACIDUM, PYRUVIC ACID, SUCCINICUM ACIDUM, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, GERMANIUM SESQUIOXIDE, MERCURIUS VIVUS, NUX VOMICA, KIDNEY (SUIS), LYMPH NODE (SUIS), NAPHTHOCHINONUM, NATRUM OXALACETICUM, PHOSPHORUS, URINARY BLADDER (SUIS), ACONITICUM ACIDUM, CIS-Energique, Inc.23de6b8e-7622-4ba6-89f7-37bd151687e22026-02-26WarningsExact identifier
unii: XF417D3PSL
Leader Extra Strength Effervescent Antacid and Pain RelieverASPIRIN, CITRIC ACID, SODIUM BICARBONATECardinal Healthc5d7bf5f-3e59-52f2-e053-2a95a90a4a002026-02-25WarningsExact identifier
unii: XF417D3PSL
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONERedpharm Drug300ae3d0-464c-d0be-e063-6294a90a7f9d2026-02-21Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEUnit Dose Solutions, Inc.4b301ad7-ac0e-f849-e063-6394a90a27d52026-02-19Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Mitochondria ProARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM,Energique, Inc.2f365207-b730-428d-9465-8853e86e79ff2026-02-18WarningsExact identifier
unii: XF417D3PSL
BuprenorphineBUPRENORPHINESun Pharmaceutical Industries, Inc.9fd1f18f-0b0f-4059-b603-19ecbf0ed63a2026-02-11Warnings, Adverse reactionsExact identifier
rxcui: 351265
rxcui: 351264
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
rxcui: 351265
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
Additive Formula 3DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINETerumo BCT, Ltd9a5247a1-cc05-442d-b2d0-950f887f03c22026-01-30Warnings, Adverse reactionsExact identifier
unii: B22547B95K
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONECamber Pharmaceuticals, Inc.221195e4-de08-414c-af08-a611a74789de2026-01-30Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAtlantic Biologicals Corp.42d837ae-2578-46df-92d2-24774964aaad2026-01-28Adverse reactionsExact identifier
unii: XF417D3PSL
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONECamber Pharmaceuticals, Inc.5ab2d4e4-3c8c-413a-b147-23eafbde313a2026-01-28Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1

Reported adverse events (FAERS/openFDA)#

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