FDA.reportPublic FDA data

NDC 63629-9475-01 - 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
63629-9475
Requested NDC
63629-9475-01
Package NDCs from labels
63629-9475-1, 63629-9475-01
Manufacturer
Bryant Ranch Prepack
Effective date
2026-06-03
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 Prepack2026-06-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-9475-1BUPRENORPHINE30 in 1 BOTTLETABLET30104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9475BUPRENORPHINE TABLET [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 1 package rows20240821_bc5a7137-9e8f-438e-84d9-bdbf1db12998.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9475-1EA - Each63629-9475cf0fb5b3-acf1-437f-890e-4055685acd7312023-01-09

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 3 of 12 · 235 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEBryant Ranch Prepackb9b5b1d5-482e-42ad-aabd-869e9ade51262026-05-14Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
buprenorphine hydrochloride and naloxone hydrochloride dihydrateBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEBryant Ranch Prepacka0f8c28c-ed9a-4a26-91a3-b996c117ac2c2026-05-14Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
buprenorphine hydrochloride and naloxone hydrochloride dihydrateBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEBryant Ranch Prepackd25b1a73-9794-4e86-82eb-dee3f159a2142026-05-13Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Market Basket Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEDemoulas Super Markets, Inc.e15439c7-0e3c-7752-e053-2995a90a1a402026-05-11WarningsExact identifier
unii: XF417D3PSL
Meijer Effervescent Antacid and Pain ReliefASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEMeijer Distribution Inc7305972b-aa0f-4daa-e053-2991aa0adfd72026-05-11WarningsExact identifier
unii: XF417D3PSL
BUPRENORPHINEBUPRENORPHINERhodes Pharmaceuticals LLCda90618a-5621-4b15-bc48-9dcc631418de2026-05-04Warnings, Adverse reactionsExact identifier
application number: ANDA207276
ndc (product): 42858-501
rxcui: 351265
rxcui: 351264
spl id: 5f1402cd-d222-4604-bef0-daa2b15bb4a8
spl set id: da90618a-5621-4b15-bc48-9dcc631418de
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONERhodes Pharmaceuticals LLC794724a6-0fba-bc8d-ecdb-9e3be8ea21912026-05-01Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
buprenorphine hydrochloride and naloxone hydrochloride dihydrateBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEGolden State Medical Supply, Inc.4f6e0056-b19d-0d0e-e063-6294a90a16e52026-04-24Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONERedpharm Drug5005a6c8-9a3b-a99a-e063-6294a90aac132026-04-22Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
MannitolMANNITOLHospira, Inc.8ad3145e-00e7-4412-b9a5-06f00f264f302026-04-21Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEBryant Ranch Prepack63aaa6cc-8574-4990-8239-6fdeffce92c82026-04-16Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEUnit Dose Solutions, Inc.4f979409-f9a2-d3a2-e063-6394a90accd02026-04-16Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
CLENPIQSODIUM PICOSULFATE, MAGNESIUM OXIDE, AND ANHYDROUS CITRIC ACIDFerring Pharmaceuticals Inc.e95fff66-4ec0-4001-a727-33e66a5ec7d52026-04-15Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
Anticoagulant Sodium CitrateTRISODIUM CITRATE DIHYDRATELABORATORIOS GRIFOLS SAdb8334be-5b8b-4811-811a-efbe32b6d1472026-04-14WarningsExact identifier
unii: B22547B95K
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEAveva Drug Delivery Systems Inc.cb112448-49a1-4209-bcdb-7cfae6501f512026-04-07Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
BUPRENORPHINEBUPRENORPHINEBryant Ranch Prepackcd0a90c6-32cc-4114-8573-86ac85503bdf2026-04-03Warnings, Adverse reactionsExact identifier
application number: ANDA207276
rxcui: 351264
unii: 56W8MW3EN1
Buprenorphine HCl and Naloxone HClBUPRENORPHINE AND NALOXONEBryant Ranch Prepack2aaad1a7-a0fd-4dd5-bb53-03afad8f10b92026-04-03Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEINGENUS PHARMACEUTICALS, LLC4951ec29-609b-4836-b0e4-0d9c1d6ae6fe2026-03-23Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1

Reported adverse events (FAERS/openFDA)#

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