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 10 of 47 · 940 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM BIO18CALC FLUOR, CALC SULF, SILICEA.BM Private Limited4d269a3b-18ba-3ad2-e063-6294a90a1fae2026-03-16WarningsExact identifier
unii: ETJ7Z6XBU4
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEAsclemed USA, Inc.d1d0872c-5b11-4e13-a401-b122348e0fa72026-03-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993541
unii: ZG7E5POY8O
LigatoneARNICA MONTANA, BRYONIA, CALCAREA PHOSPHORICA, CAUSTICUM, KALI CARBONICUM, MANGANESE GLUCONATE, MEZEREUM, RHUS TOX, RUTA GRAVEOLENS, SILICEABioActive Nutritional, Inc.3a3bdd55-daec-43b9-a380-54a747fb7d102026-03-13WarningsExact identifier
unii: ETJ7Z6XBU4
Skin Irritations and Itch ReliefAGARICUS MUSCARIUS, ALUMINA, ANAGALLIS ARVENSIS, ANTIMONIUM TARTARICUM, APIS MELLIFICA, ARSENICUM ALBUM, ARSENICUM IODATUM, BOVISTA, CAUSTICUM, DOLICHOS PRURIENS, FAGOPYRUM ESCULENTUM, GRAPHITES, KALI MURIATICUM, MURIATICUM ACIDUM, OLEANDER, PETROLEUM, PIX LIQUIDA, RADIUM BROMATUM (12X, 30X, 1LM), RHUS TOX, SELENIUM METALLICUM, SULPHUR AND URTICA URENS.King Bio Inc.d139d2f1-0369-4963-9f3d-c4cc0f1ea2dd2026-03-10WarningsExact identifier
unii: QTT17582CB
Lower GI and Probiotic RestorationAETHUSA CYNAPIUM, ALLIUM SATIVUM, BAPTISIA TINCTORIA, CAPSICUM ANNUUM, CARBO VEGETABILIS, CHAMOMILLA, CINCHONA OFFICINALIS, COLLINSONIA CANADENSIS, COLOCYNTHIS, CONDURANGO, GAMBOGIA, GRATIOLA OFFICINALIS, LAC VACCINUM, LACTICUM ACIDUM, NATRUM CARBONICUM, NUX VOMICA, PODOPHYLLUM PELTATUM, SEPIA AND SILICEA.King Bio Inc.2e1f3ca1-9036-4f14-bd3c-d0eed9a9ff932026-03-10WarningsExact identifier
unii: ETJ7Z6XBU4
Constitutional EnhancerACONITUM NAPELLUS, ARSENICUM ALBUM, BARYTA CARBONICA, BRYONIA, CALCAREA CARBONICA, CANTHARIS, GELSEMIUM SEMPERVIRENS, GRAPHITES, HYDRASTIS CANADENSIS, KALI IODATUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHUS TOX, SEPIA, SILICEA AND SULPHUR.King Bio Inc.448becd7-58aa-40ae-9b4b-39f48a8f13dd2026-03-10WarningsExact identifier
unii: ETJ7Z6XBU4
VermiclearGRANATUM, RHAMNUS PURSHIANA, JUGLANS REGIA, FILIX MAS, ABSINTHIUM, AESCULUS HIPPOCASTANUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, CINA, CINCHONA OFFICINALIS, CUPRUM METALLICUM, IPECACUANHA, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, NUX VOMICA, PODOPHYLLUM PELTATUM, PULSATILLA (VULGARIS), RATANHIA, RHUS TOX, SABADILLA, SILICEA, SPIGELIA ANTHELMIA, TEREBINTHINA, TEUCRIUM MARUMEnergique, Inc.f7cf3edd-2451-4a4f-b1f2-1b3db2bb4dca2026-03-09WarningsExact identifier
unii: ETJ7Z6XBU4
Artificial TearsGLYCERINPreferred Pharmaceuticals Inc.dd646c72-8f47-43c6-a734-db0dcc8cd4d12026-03-06WarningsExact identifier
unii: 3NXW29V3WO
OsteoplexEQUISETUM HYEMALE, MAGNESIA MURIATICA, ASCORBICUM ACIDUM, MANGANUM MURIATICUM, SYMPHYTUM OFFICINALE, MEDULLA OSSIS SUIS, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEA, PARATHYROID GLAND (SUIS), LIGAMENT (SUIS)BioActive Nutritional, Inc.8a7e1397-a387-4f2c-ab4f-7f1a7f1a849b2026-03-05WarningsExact identifier
unii: ETJ7Z6XBU4
Respiforce A-HPARSENICUM ALBUM, BELLADONNA, IPECACUANHA, KALI CARBONICUM, LOBELIA INFLATA, NATRUM SULPHURICUM, SILICEABioActive Nutritional, Inc.ebf5f0c7-e7a4-45fe-acfd-52c46a8d789c2026-03-05WarningsExact identifier
unii: ETJ7Z6XBU4
Sinus Defense 2.0LAC VACCINUM, SILICEA, ASPERGILLUS NIGER, BABESIA MICROTI, BORRELIA BURGDORFERI, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, CHLAMYDIA TRACHOMATIS, COLIBACILLINUM CUM NATRUM MURIATICUM, CYTOMEGALOVIRUS NOSODE, EHRLICHIA NOSODE, HERPES SIMPLEX I AND II NOSODE, HUMAN PAPILLOMA NOSODE, KLEBSIELLA PNEUMONIAE, MUCOR RACEMOSUS, MYCOBACTERIUM PARATUBERCULOSIS, PNEUMOCCOCCINUM, STAPHYLOCOCCUS AUREUS, STREPTOCOCCUS VIRIDANS, EPSTEIN-BARR VIRUS NOSODE, HERPES ZOSTER NOSODEMicro Balance Health Products LLC560f84f6-2544-4ba8-8236-a95906eb7d972026-03-04WarningsExact identifier
unii: ETJ7Z6XBU4
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEA-S Medication Solutionsd86e26e0-6e10-4d59-8cc8-94b551774b862026-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Snore ControlBROMIUM, CHAMOMILLA, CINCHONA, CUPRUM METALLICUM, HELLEBORUS NIGER, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, LAUROCERASUS, NUX VOMICA, PHOSPHORICUM ACIDUM, RHUS TOX, SILICEA, STRAMONIUM, SULPHUR AND ZINCUM METALLICUM.King Bio Inc.704bb574-6c54-49d1-bdae-81ffe0e79d102026-03-04WarningsExact identifier
unii: ETJ7Z6XBU4
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEMajor Pharmaceuticalsb127d3fc-be5e-4c12-8026-205766bf8e7f2026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Refresh Optive Mega-3 PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.326cb5d6-c784-404f-9a13-6d69262dda6e2026-03-01WarningsExact identifier
unii: 6OZP39ZG8H
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEEpic Pharma, LLCf79d1422-a9b6-41c2-a46d-22886605f94d2026-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993557
rxcui: 993541
unii: ZG7E5POY8O
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEEpic Pharma, LLCf56ccdb1-f9d9-3e5f-e053-2995a90a8f162026-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC4bd469b8-fb35-0223-e063-6294a90ae7bc2026-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
911 Adrenal Burnout and FatigueACETICUM AC, ADRENALINUM, ADRENOCORTICOTROPHIN (30X), AESCULUS HIPPOCASTANUM, FLOS, ALFALFA, ALPHA-LIPOIC AC, AMBRA, ARG NIT, AVENA SATIVA, BRYONIA, CARBONEUM OXYGENISATUM, CARPINUS BETULUS, FLOS, DNA, FUMARICUM ACIDUM, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, HYPOTHALAMUS, KALI PHOSPHORICUM, LACTICUM ACIDUM, LECITHIN, NATRUM MURIATICUM, OXALICUM ACIDUM, PHOSPHORICUM ACIDUM, PITUITARUM POSTERIUM, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SEPIA, SILICEA, SUCCINICUM ACIDUM AND THYROIDINUM.King Bio Inc.21c6b6c1-e846-4f25-a1dc-02e79d1be7562026-02-26WarningsExact identifier
unii: ETJ7Z6XBU4
ResilienceCEREBRUM SUIS, HYPOTHALAMUS SUIS, HYPOPHYSIS SUIS, SEROTONIN (HYDROCHLORIDE), NPY (NEUROPEPTIDE Y), CALCAREA CARBONICA, SILICEA, VERATRUM ALBUM, BLATTA AMERICANA, CACAO, DIOSPYROS KAKI, FORMICA RUFA, PALOONDO, SULPHUR, TAXUS BACCATA, TELA ARANEAE, SALIX VITELLINA, FLOSDeseret Biologicals, Inc.3aa6c1e7-2bd9-4c2d-bfd4-63ffb7c62e9c2026-02-26WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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