FDA.reportPublic FDA data

NDC 63629-5074-01 - Buprenorphine HCl and Naloxone HCl

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
63629-5074
Requested NDC
63629-5074-01
Package NDCs from labels
63629-5074-1, 63629-5074-2, 63629-5074-3, 63629-5074-4, 63629-5074-5, 63629-5074-6, 63629-5074-7, 63629-5074-8, 63629-5074-9, 63629-5074-0, 63629-5074-01
Manufacturer
Bryant Ranch Prepack
Effective date
2026-04-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Buprenorphine HCl and Naloxone HCl - Bryant Ranch PrepackBryant Ranch Prepack2026-04-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-5074-0Buprenorphine HCl and Naloxone HCl42 in 1 BOTTLETABLET421007
63629-5074-1Buprenorphine HCl and Naloxone HCl30 in 1 BOTTLETABLET301007
63629-5074-2Buprenorphine HCl and Naloxone HCl60 in 1 BOTTLETABLET601007
63629-5074-3Buprenorphine HCl and Naloxone HCl90 in 1 BOTTLETABLET901007
63629-5074-4Buprenorphine HCl and Naloxone HCl120 in 1 BOTTLETABLET1201007
63629-5074-5Buprenorphine HCl and Naloxone HCl14 in 1 BOTTLETABLET141007
63629-5074-6Buprenorphine HCl and Naloxone HCl28 in 1 BOTTLETABLET281007
63629-5074-7Buprenorphine HCl and Naloxone HCl6 in 1 BOTTLETABLET61007
63629-5074-8Buprenorphine HCl and Naloxone HCl10 in 1 BOTTLETABLET101007
63629-5074-9Buprenorphine HCl and Naloxone HCl21 in 1 BOTTLETABLET211007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-5074BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]1006Current NDC, 10 package rows20240518_2aaad1a7-a0fd-4dd5-bb53-03afad8f10b9.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPRENORPHINE HYDROCHLORIDEACTIVE INGREDIENT56W8MW3EN1BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]1000
NALOXONE HYDROCHLORIDE DIHYDRATEACTIVE INGREDIENT5Q187997EEBUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]1000
BUPRENORPHINEACTIVE MOIETY40D3SCR4GZBUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]1000
NALOXONEACTIVE MOIETY36B82AMQ7NBUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]1000
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]1000
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLBUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]1000
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]1000
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]1000
MANNITOLINACTIVE INGREDIENT3OWL53L36ABUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]1000
POVIDONESINACTIVE INGREDIENTFZ989GH94EBUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]1000
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRBUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]1000
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]1000

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 15 · 296 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEBryant Ranch Prepackfc2755a5-3292-4b49-872d-e22c386a4e442026-06-11Warnings, Adverse reactionsExact identifier
rxcui: 351266
Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATESpecGx LLC62abde41-46cb-4e90-a798-23d6531bf9aa2026-06-10Warnings, Adverse reactionsExact identifier
rxcui: 351266
rxcui: 351267
unii: 5Q187997EE
unii: 56W8MW3EN1
Buprenorphine HCl and Naloxone HClBUPRENORPHINE AND NALOXONEBryant Ranch Prepacke82e2d74-33a8-4894-82f6-788fc0f9feec2026-06-08Warnings, Adverse reactionsExact identifier
application number: ANDA203136
rxcui: 351266
unii: 5Q187997EE
unii: 56W8MW3EN1
Buprenorphine HClBUPRENORPHINE HCLSpecGx LLCb60d514d-a88a-4fa2-a5b0-30ac29e049732026-06-05Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEBryant Ranch Prepackdd3bfccd-86a1-413f-affd-187f81dd07aa2026-06-03Warnings, Adverse reactionsExact identifier
rxcui: 351267
unii: 5Q187997EE
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEBryant Ranch Prepackdd6e4fc9-a6f7-458a-b075-d736ce8b71722026-06-03Warnings, Adverse reactionsExact identifier
rxcui: 351266
unii: 5Q187997EE
unii: 56W8MW3EN1
BUPRENORPHINEBUPRENORPHINEBryant Ranch Prepackbc5a7137-9e8f-438e-84d9-bdbf1db129982026-06-03Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
BuprenorphineBUPRENORPHINEActavis Pharma, Inc.03819118-86f6-4329-adaf-4599e7b71f462026-05-25Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
unii: FZ989GH94E
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATESelect Consumer Group3ca80d74-1e8b-49d9-e063-6394a90a43122026-05-24WarningsExact identifier
unii: XF417D3PSL
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEREMEDYREPACK INC.072b2c2e-a564-4bb4-8954-9349a79238072026-05-22Warnings, Adverse reactionsExact identifier
rxcui: 351267
unii: 5Q187997EE
unii: 56W8MW3EN1
Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEBryant Ranch Prepackb9b5b1d5-482e-42ad-aabd-869e9ade51262026-05-14Warnings, Adverse reactionsExact identifier
rxcui: 351267
unii: 5Q187997EE
unii: 56W8MW3EN1
buprenorphine hydrochloride and naloxone hydrochloride dihydrateBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEBryant Ranch Prepacka0f8c28c-ed9a-4a26-91a3-b996c117ac2c2026-05-14Warnings, Adverse reactionsExact identifier
rxcui: 351266
unii: 5Q187997EE
unii: 56W8MW3EN1
buprenorphine hydrochloride and naloxone hydrochloride dihydrateBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEBryant Ranch Prepackd25b1a73-9794-4e86-82eb-dee3f159a2142026-05-13Warnings, Adverse reactionsExact identifier
rxcui: 351266
unii: 5Q187997EE
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
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONERhodes Pharmaceuticals LLC794724a6-0fba-bc8d-ecdb-9e3be8ea21912026-05-01Warnings, Adverse reactionsExact identifier
rxcui: 351266
rxcui: 351267
unii: 5Q187997EE
unii: 56W8MW3EN1
iVIZIA Lubricant Eye GelPOVIDONEThea Pharma Inc.1f06ca1a-5270-9a82-e063-6294a90aed642026-04-29WarningsExact identifier
unii: FZ989GH94E
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLPreferred PHarmaceuticals Inc.011473a8-26d5-4661-b3c0-745f9b6aa1d82026-04-29WarningsExact identifier
unii: FZ989GH94E

Reported adverse events (FAERS/openFDA)#

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