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 9 of 47 · 940 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bupropion hydrochloride SRBUPROPION HYDROCHLORIDESolco Healthcare US LLC39b2d509-1281-4464-9cf1-a94bbc18b84b2026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEBryant Ranch Prepackfd153957-ff74-4134-8545-cdc0e56199062026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
LymphoplexMYRRHA, TRIGONELLA FOENUM-GRAECUM, PINUS SYLVESTRIS, LYMPH (SUIS), SPLEEN (SUIS), CONIUM MACULATUM, ECHINACEA (ANGUSTIFOLIA), HEPAR SULPHURIS CALCAREUM, HYDRANGEA ARBORESCENS, PHYTOLACCA DECANDRA, SILICEABioActive Nutritional, Inc.624f35db-291e-4e7f-a2c9-ae319717157a2026-03-30WarningsExact identifier
unii: ETJ7Z6XBU4
Equisetum SiliceaEQUISETUM SILICEAUriel Pharmacy Inc.e88b820b-4a07-42e2-8fe2-b30729e91a8c2026-03-30WarningsExact identifier
unii: ETJ7Z6XBU4
B Force HPAPIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, LACHESIS MUTUS, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEABioActive Nutritional, Inc.811c6f32-fcad-464c-bcf6-ae6a59195b1c2026-03-30WarningsExact identifier
unii: ETJ7Z6XBU4
LymphdrainexGERANIUM ROBERTIANUM, NASTURTIUM AQUATICUM, TEUCRIUM SCORODONIA, EQUISETUM HYEMALE, FUMARIA OFFICINALIS, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, PINUS SYLVESTRIS, VERONICA OFFICINALIS, BAPTISIA TINCTORIA, GALIUM APARINE, GENTIANA LUTEA, APIS MELLIFICA, SARSAPARILLA (SMILAX REGELII), BARYTA CARBONICA, HEPAR SULPHURIS CALCAREUM, MERCURIUS CYANATUS, SCROPHULARIA NODOSA, ALOE, FERRUM IODATUM, MYOSOTIS ARVENSIS, ARANEA DIADEMA, CALCAREA PHOSPHORICA, JUGLANS REGIA, PARATHYROID GLAND (BOVINE), SILICEA,Energique, Inc.c512f211-f4f8-46f6-87ed-dd50287359df2026-03-27WarningsExact identifier
unii: ETJ7Z6XBU4
Crocodile Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Crocodile Tears LLC4df29336-ea0c-0484-e063-6294a90a685a2026-03-26WarningsExact identifier
unii: 3NXW29V3WO
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEA-S Medication Solutions30c5b97c-b19d-4d27-bb1a-ab19b7dfccaa2026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEMAJOR PHARMACEUTICALS3c6b5ab4-9671-4fcd-8b4c-7f230dcfe6c92026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400KC Pharmaceuticals, Inc4de5c844-85ca-ff9f-e063-6394a90ac12c2026-03-25WarningsExact identifier
unii: 3NXW29V3WO
A plus AttentionBARYTA CARBONICA, CALCAREA PHOSPHORICA, SILICEA, GELSEMIUM SEMPERVIRENS, NUX VOMICA, SINAPIS NIGRANaturalCaree77c2661-7ddf-4b09-b2e3-b9db3911011a2026-03-24WarningsExact identifier
unii: ETJ7Z6XBU4
Bupropion hydrochlorideBUPROPION HYDROCHLORIDECamber Pharmaceuticals, Inc.f69b322b-93ab-407a-bf25-fe13c6896ca62026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEPreferred Pharmaceuticals, Inc.c0445fea-108f-4e00-a2ae-ebbdf27199472026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEPreferred Pharmaceuticals, Inc.d1d1ed19-e111-4652-a0d4-9406e6f73e9f2026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEPreferred Pharmaceuticals Inc.42e228a2-25b3-44a6-8da7-6616ca44ac7f2026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993541
unii: ZG7E5POY8O
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEPreferred Pharmaceuticals, Inc.0b33fb1f-a7f0-4ab7-a882-eca2d2c77afa2026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEPreferred Pharmaceuticals Inc.eabb54b7-164c-4de8-b91a-f2e65637b5fc2026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Nail Fungus ControlCALENDULA OFFICINALIS FLOWERING TOP AND SILICON DIOXIDEForces of Natureb7239e23-326e-4c1d-a080-55f457f1c4542026-03-19WarningsExact identifier
unii: ETJ7Z6XBU4
Bupropion HydrochlorideBUPROPION HYDROCHLORIDECadila Pharmaceuticals Limited33210109-2ddb-4b0f-a45e-988e493ca6282026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Otoflam HPBELLADONNA, CONIUM MACULATUM, DULCAMARA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA (VULGARIS), SILICEA, CHAMOMILLABioActive Nutritional, Inc.12f1ef62-93f3-45b8-885d-1b82f85a83552026-03-17WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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