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 4 of 15 · 298 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
rxcui: 351266
rxcui: 351267
unii: 5Q187997EE
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
rxcui: 351267
unii: 5Q187997EE
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
rxcui: 351266
rxcui: 351267
unii: 5Q187997EE
unii: 56W8MW3EN1
CLENPIQSODIUM PICOSULFATE, MAGNESIUM OXIDE, AND ANHYDROUS CITRIC ACIDFerring Pharmaceuticals Inc.e95fff66-4ec0-4001-a727-33e66a5ec7d52026-04-15Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
FreshKote Preservative Free Lubricant Eye DropsPOVIDONE, POLYVINYL ALCOHOLEyevance Pharmaceuticalsf51c50c3-43ae-4169-9d2b-22b239461dd12026-04-08WarningsExact identifier
unii: FZ989GH94E
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEAveva Drug Delivery Systems Inc.cb112448-49a1-4209-bcdb-7cfae6501f512026-04-07Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDChartwell Governmental & Specialty RX, LLC58c24504-47de-487a-ab8d-18add155ea952026-04-07Adverse reactionsExact identifier
unii: 1Q73Q2JULR
BUPRENORPHINEBUPRENORPHINEBryant Ranch Prepackcd0a90c6-32cc-4114-8573-86ac85503bdf2026-04-03Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine HCl and Naloxone HClBUPRENORPHINE AND NALOXONEBryant Ranch Prepack2aaad1a7-a0fd-4dd5-bb53-03afad8f10b92026-04-03Warnings, Adverse reactionsExact identifier
application number: ANDA203136
ndc (package): 63629-5074-9
ndc (package): 63629-5074-6
ndc (package): 63629-5074-0
ndc (package): 63629-5074-5
ndc (package): 63629-5074-7
ndc (package): 63629-5074-8
ndc (package): 63629-5074-2
ndc (package): 63629-5074-4
ndc (package): 63629-7269-1
ndc (package): 63629-5074-1
ndc (package): 63629-5074-3
ndc (product): 63629-5074
ndc (product): 63629-7269
ndc11 (package): 63629507401
rxcui: 351266
rxcui: 351267
spl id: ff43dbe4-d5eb-4eb9-a779-0066c59b633f
spl set id: 2aaad1a7-a0fd-4dd5-bb53-03afad8f10b9
unii: 5Q187997EE
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEINGENUS PHARMACEUTICALS, LLC4951ec29-609b-4836-b0e4-0d9c1d6ae6fe2026-03-23Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine HClBUPRENORPHINE HCLREMEDYREPACK INC.69a647c0-bc09-4ee2-aeb3-ef286caf25e52026-03-23Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Leader Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLCardinal Health5c5d6c13-9b51-48f0-8627-b60b0f707fd32026-03-12WarningsExact identifier
unii: FZ989GH94E
buprenorphine hydrochloride and naloxone hydrochloride dihydrateBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEClinical Solutions Wholesale, LLC99a5b62f-bc08-44f4-abb8-300520d2162a2026-03-06Warnings, Adverse reactionsExact identifier
rxcui: 351266
rxcui: 351267
unii: 5Q187997EE
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
rxcui: 351266
unii: 5Q187997EE
unii: 56W8MW3EN1
buprenorphine hydrochloride and naloxone hydrochloride dihydrateBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEMajor Pharmaceuticalsc5fbec69-e7de-44a8-b9fa-0378ae61a9fe2026-03-03Warnings, Adverse reactionsExact identifier
rxcui: 351266
rxcui: 351267
unii: 5Q187997EE
unii: 56W8MW3EN1
buprenorphine hydrochlorideBUPRENORPHINE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma442831cf-9636-433a-9a12-e9a8cd31f72a2026-02-28Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1

Reported adverse events (FAERS/openFDA)#

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