FDA.reportPublic FDA data

NDC 63629-8475-01 - Bupropion Hydrochloride (XL)

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
63629-8475
Requested NDC
63629-8475-01
Package NDCs from labels
63629-8475-1, 63629-8475-01
Manufacturer
Bryant Ranch Prepack
Effective date
2026-04-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Bupropion Hydrochloride (XL) - Bryant Ranch PrepackBryant Ranch Prepack2026-04-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8475-1Bupropion Hydrochloride(XL)500 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE500104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8475BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 1 package rows20240112_a5417808-f767-48fc-9f5d-c1aeee4e57c3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8475-1EA - Each63629-84753cc78a82-fde3-4dd2-a710-8e3467151a3b12021-07-15

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 47 · 940 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Jacksons Cell Salts SKIN BALANCECALC SULPH, KALI SULPH, SILICEAZettl Health Inc.54012f03-4c34-42f5-e063-6394a90aacc52026-06-11WarningsExact identifier
unii: ETJ7Z6XBU4
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEBryant Ranch Prepack82bcdd72-9146-4c8d-a8aa-f920158646052026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993557
unii: ZG7E5POY8O
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepackaf5b1cc8-f078-4a7b-b64a-4cb2de1e57212026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993541
unii: ZG7E5POY8O
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEBryant Ranch Prepackeb25adb1-9841-42ce-aa22-718fb0fba5dd2026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993541
unii: ZG7E5POY8O
Bupropion Hydrochloride (XL)BUPROPION HYDROCHLORIDEBryant Ranch Prepack8499470a-8d01-4348-b67b-8f49728031cb2026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207479
rxcui: 993557
unii: ZG7E5POY8O
BM BM5 DROPSAPIS MELL, BAPTISIA, CONIUM MAC, ECHINACEA, EUPATORIUM PERF, SILICEA, THUJA OCCBM Private Limited53e763ee-9a44-a914-e063-6394a90aeb3c2026-06-10WarningsExact identifier
unii: ETJ7Z6XBU4
GUNA-AWARENESSBETAINE - BUFO BUFO CUTANEOUS GLAND - CALCIUM CARBONATE - CHROMIC SULFATE - CICUTA VIROSA ROOT - COPPER - FOLIC ACID - GOLD - COBALAMIN - IRON - LACHESIS MUTA VENOM - MELATONIN - MOLYBDENUM - NEUROTROPHIN-3 - NEUROTROPHIN-4 - OXYTOCIN - SILICON DIOXIDE - SUS SCROFA FRONTAL LOBE - SUS SCROFA TEMPORAL LOBE - THYROTROPIN ALFA - UBIDECARENONE - VANADIUM - ZINC - BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN -Guna spa10e46b39-7903-4390-b72d-865291245b4c2026-06-10WarningsExact identifier
unii: ETJ7Z6XBU4
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepack5c111cf0-0199-4a4d-8138-81579af4c14d2026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepack4c9a5dc3-bebe-431a-b550-ce46c6c6b01e2026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited53d1c51a-77eb-bb3c-e063-6394a90aab3f2026-06-09WarningsExact identifier
unii: ETJ7Z6XBU4
BM BIO18CALC FLUOR, CALC SULF, SILICEA.Total Operations Management LLC DBA:Bestmade Natural Products Micro53d3c1d6-d0ba-5ea7-e063-6394a90a02942026-06-09WarningsExact identifier
unii: ETJ7Z6XBU4
BM SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro53bb3927-6053-eb3d-e063-6394a90a5ddf2026-06-08WarningsExact identifier
unii: ETJ7Z6XBU4
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEUnit Dose Solutions, Inc.53c192ca-ac51-cb87-e063-6394a90a6c082026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993557
unii: ZG7E5POY8O
bupropion HydrochlorideBUPROPION HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.434aacf8-87f1-44fc-a66b-92ae0022de0e2026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
ScrofularoforceRUMEX CRISPUS, XANTHOXYLUM FRAXINEUM, LYMPH NODE (SUIS), SCROPHULARIA NODOSA, BARYTA CARBONICA, BARYTA MURIATICA, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, HELLEBORUS NIGER, IODIUM, KALI PHOSPHORICUM, LACHESIS MUTUS, NATRUM PHOSPHORICUM, SILICEA, JUNIPERUS VIRGINIANABioActive Nutritional, Inc.737cd410-0405-41b0-b7f2-29bb200378492026-06-08WarningsExact identifier
unii: ETJ7Z6XBU4
bupropion hydrochloride SRBUPROPION HYDROCHLORIDEMajor Pharmaceuticals67b6bcf8-0e7c-4e74-ad72-54f1bd6e65ad2026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
VAXBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, TRIFOLIUM PRATENSE, ARNICA MONTANA, CALENDULA OFFICINALIS, CHELIDONIUM MAJUS, LEPTANDRA VIRGINICA, LIGUSTICUM PORTERI, LOMATIUM DISSECTUM, MYRRHA, NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, TRIGONELLA FOENUM-GRAECUM, URTICA DIOICA, HYDRASTIS CANADENSIS, ASTRAGALUS MEMBRANACEUS, PROPOLIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, LYCOPODIUM CLAVATUM, RHUS TOX, SILICEA,BioActive Nutritional, Inc.faa4a678-321a-4982-a5d4-01b713e6862d2026-06-08WarningsExact identifier
unii: ETJ7Z6XBU4
VermexARTEMISIA VULGARIS, CINA, TEUCRIUM MARUM, SPIGELIA ANTHELMIA, FILIX MAS, CALCAREA CARBONICA, GRAPHITES, MERCURIUS CORROSIVUS, SABADILLA, SILICEA, TANACETUM VULGARE, ASCARIS LUMBRICOIDES, TAENIA SOLIUMBioActive Nutritional, Inc.6be5fbcf-bb22-4b20-b65a-d943c516adf92026-06-04WarningsExact identifier
unii: ETJ7Z6XBU4
BM Silicea Icing SugarSILICEA ICING SUGARTotal Operations Management LLC DBA:Bestmade Natural Products Micro535ba100-627f-36b4-e063-6394a90a33732026-06-03WarningsExact identifier
unii: ETJ7Z6XBU4
Rohto Digi-EyeHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDEThe Mentholatum Company5d6f37b9-b568-4cb6-92de-eb40779f3f8c2026-06-03WarningsExact identifier
unii: 3NXW29V3WO

Reported adverse events (FAERS/openFDA)#

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