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 45 of 46 · 912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GUNA MATRIX DETOXSODIUM SULFATE - PODOPHYLLUM PELTATUM ROOT - SOLIDAGO VIRGAUREA FLOWERING TOP - APIS MELLIFERA - EQUISETUM HYEMALE - STRYCHNOS NUX VOMICA SEED - HAMAMELIS VIRGINIANA ROOT BARK STEM BARK - LYCOPODIUM CLAVATUM SPORE - GALIUM APARINE WHOLE - THUJA OCCIDENTALIS LEAFY TWIG - BERBERIS VULGARIS ROOT BARK - MYOSOTIS ARVENSIS - CHELIDONIUM MAJUS WHOLE - FUCUS VESICULOSUS -Guna spaa369b95b-4d57-f149-e053-2995a90a87e32020-10-23Warnings, Adverse reactionsExact identifier
unii: ETJ7Z6XBU4
SupremeABROTANUM, ANACARDIUM ORIENTALE, ARSENICUM ALBUM, BARYTA MURIATICA, HELLEBORUS NIGER, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NICOTINAMIDUM, SECALE CORNUTUM, THYMUS (BOVINE), THYROIDINUM (BOVINE), CALCAREA CARBONICA, CALCAREA PHOSPHORICA, HYPOTHALAMUS SUIS, PITUITARUM POSTERIUM (BOVINE), SILICEABOUARI GROUP, LLC dba WEIGHT LOSS COMPANY, THE72c4679b-aa97-4888-9178-581d0f99c0b62020-09-11WarningsExact identifier
unii: ETJ7Z6XBU4
Bupropion Hydrochloride (XL)BUPROPION HYDROCHLORIDECIPLA USA INC.,c2cf79d7-1aba-4391-980b-5e218781f7c62020-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993557
rxcui: 993541
unii: ZG7E5POY8O
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEProficient Rx LP4a2be6af-e256-4fa9-bfa9-5300d52cdaf42020-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993541
unii: ZG7E5POY8O
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEProficient Rx LPa165869a-9bc4-4987-babe-a77fad78c38f2020-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEProficient Rx LPd4272e3f-78ee-4d80-b911-e840fb14acbe2019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Skin Klear Acne ReliefTRIBASIC CALCIUM PHOSPHATE, FUMARIA OFFICINALIS FLOWERING TOP, ARCTIUM LAPPA ROOT, SODIUM CHLORIDE, SAPONARIA OFFICINALIS ROOT, SILICON DIOXIDE, SOLIDAGO VIRGAUREA FLOWERING TOP, SULFUR, VIOLA TRICOLORHomeocare Laboratories65afbc20-611b-4bc4-a151-c633bec66a822018-12-31WarningsExact identifier
unii: ETJ7Z6XBU4
Sinus ReliefASAFETIDA, ECHINACEA ANGUSTIFOLIA, CALCIUM SULFIDE, POTASSIUM DICHROMATE, LUFFA OPERCULATA WHOLE, SILICON DIOXIDE, SINUSITISINUMHomeocare Laboratories84483171-df92-47de-9203-ed02d64fb5fb2018-12-31WarningsExact identifier
unii: ETJ7Z6XBU4
Hair-X Hair Loss ReliefCADMIUM SULFATE, GRAPHITE, PHOSPHORIC ACID, SILICON DIOXIDE, SELENIUM, THALLIUM, USTILAGO MAYDISHomeocare Laboratories00b62179-e03b-4972-902d-3a0c969b59bc2018-12-31WarningsExact identifier
unii: ETJ7Z6XBU4
GUNA-SINUS NOSEALTHAEA OFFICINALIS LEAF - ASCORBIC ACID - BLACK CURRANT - CALCIUM SULFIDE - COPPER - ECHINACEA ANGUSTIFOLIA - GOLDENSEAL - LACHESIS MUTA VENOM - LOBARIA PULMONARIA - MANGANESE - MERCURIC SULFIDE - ONION - PLANTAGO MAJOR - POTASSIUM CARBONATE - PULSATILLA VULGARIS - SILICON DIOXIDE - SILVER NITRATE - SINUSITISINUM - SUS SCROFA NASAL MUCOSA - SUS SCROFA THYMUS - SUS SCROFA URINARY BLADDER -Guna spa36fef678-17c6-4d2a-a0f0-ddb298611f252018-12-22WarningsExact identifier
unii: ETJ7Z6XBU4
GastrozenCOFFEA TOSTA, GLYCYRRHIZA, PHYTOLACCA, TARAXACUM, HYDRASTIS, ARSENICUM ALB, GELSEMIUM, MERC SOLUB, NITRICUM AC, NUX VOM, PETROLEUM, PHOSPHORICUM AC, PHOSPHORUS, BROMIUM, CADMIUM SULPHURICUM, CINCHONA, CONIUM, HYDROGEN, IODIUM, LACHESIS, PULSATILLA, SILICEA, SULPHURICUM ACNatural Creations, Inc98dd756f-6774-47c3-bdfb-deff82fb801d2018-12-21WarningsExact identifier
unii: ETJ7Z6XBU4
Runny Nose CPALLIUM CEPA, CALC CARB, FERRUM PHOS, HEPAR SULPH CALC, LYCOPODIUM, MERC SOLUB, PULSATILLA, SILICEA, SULPHURNatural Creations, Inc868ec0ad-9344-4f94-b2c1-2abb48479b152018-12-21WarningsExact identifier
unii: ETJ7Z6XBU4
Mold AntigenALTERNARIA ALTERNATA, ASPERGILLUS FUMIGATUS, ASPERGILLUS NIGER, BOLETUS SAT, BOTRYTIS CINEREA, CLADOSPORIUM METANIGRUM, FUSARIUM OXYSPORUM, HELMINTHOSPORIUM, MUCOR MUECEDO, PULLULARIA PULLULANS, RHIZOPUS NIGRICANS, USTILAGO MAYDIS, ARSENICUM ALB, CANDIDA ALB, CARBO AN, LACHESIS, LYCOPODIUM, MERC SOLUB, NITRICUM AC, PHOSPHORUS, PULSATILLA, SEPIA, SILICEA, THUJA OCCZorex Internationalff92e909-b5a7-417f-98a4-551f1576fd1e2018-12-21WarningsExact identifier
unii: ETJ7Z6XBU4
Nausea CPAETHUSA CYNAPIUM, ANTIMON TART, ARSENICUM ALB, CALC CARB, CHAMOMILLA, CINCHONA, COCCUS, CUPRUM MET, FERRUM MET, IPECAC, KREOSOTUM, LYCOPODIUM, PETROLEUM, PULSATILLA, SILICEA, SULPHURNatural Creations, Inc2746cde1-577b-41d6-9f22-93d8f1a2c2352018-12-21WarningsExact identifier
unii: ETJ7Z6XBU4
Hydrate IIBERBER AQUI, BETA VULG, BOLDO, CARDUUS MAR, CHELIDONIUM MAJ, HORDEUM VULGARE, IRIS VERS, ROSMARINUS, TARAXACUM, AVENA, ELEUTHEROCOCCUS SENTICOSUS, XANTHOXYLUM, EQUISETUM HYEM, HYPERICUM, ULMUS FULV, GETTYSBURG AQUA, GLYCYRRHIZA, WILDBAD AQUA, CARLSBAD AQUA, ATP, HYDROGEN, NAT MUR, OXYGEN, SILICEA, WIESBADEN AQUAZorex Internationale5f53495-3b75-4d7c-89af-23058fb6fd052018-12-21WarningsExact identifier
unii: ETJ7Z6XBU4
Dust Mix AntigenANTIMON TART, ARSENICUM ALB, BLATTA OR, BROMIUM, CALC CARB, CIMEX, DROSERA, HEPAR SULPH CALC, ICTODES FOETIDA, LYCOPODIUM, PHOS, PULSATILLA, SILICEA TERRA, TABACUM FUMUSNatural Creations, Inc8dab4b4a-6fa8-4258-adc1-f8c634e2030b2018-12-21WarningsExact identifier
unii: ETJ7Z6XBU4
BUPROPION HYDROCHLORIDE (SR)BUPROPION HYDROCHLORIDECipla USA Inc.,9d2c209b-248e-4e26-9cde-fe0abe4428c12018-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion HydrochlorideBUPROPION HYDROCHLORIDESun Pharmaceutical Industries, Inc.e4e38abf-ef67-405b-af2d-3d8e4533654d2018-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993541
unii: ZG7E5POY8O
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC7d81ed30-ddf7-431a-84f8-6c630cf2b9772018-10-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
HA HPBELLADONNA, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NUX VOMICA, SILICEA, SPIGELIA ANTHELMIABioActive Nutritional, Inc.30f6c191-ce6e-438c-9601-74f5e8b61f962018-07-06WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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