FDA.reportPublic FDA data

NDC 64679-101-08 - Bupropion Hydrochloride (SR)

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
64679-101
Requested NDC
64679-101-08
Package NDCs from labels
64679-101-01, 64679-101-02, 64679-101-03, 64679-101-07, 64679-101-08, 64679-101-05
Manufacturer
Wockhardt USA LLC. | Wockhardt Limited
Effective date
2019-11-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Bupropion Hydrochloride (SR) - Wockhardt USA LLC. | Wockhardt LimitedWockhardt USA LLC. | Wockhardt Limited2019-11-26HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
64679-101-012025-12-19These highlights do not include all the information needed to use bupropion hydrochloride extended-release tablets (SR) safely and effectively. See full prescribing information for bupropion hydrochloride extended-release tablets (SR). Bupropion Hydrochloride Extended-Release Tablets, USP (SR), for oral use Initial U.S. Approval: 1985
64679-101-022025-12-19These highlights do not include all the information needed to use bupropion hydrochloride extended-release tablets (SR) safely and effectively. See full prescribing information for bupropion hydrochloride extended-release tablets (SR). Bupropion Hydrochloride Extended-Release Tablets, USP (SR), for oral use Initial U.S. Approval: 1985
64679-101-032025-12-19These highlights do not include all the information needed to use bupropion hydrochloride extended-release tablets (SR) safely and effectively. See full prescribing information for bupropion hydrochloride extended-release tablets (SR). Bupropion Hydrochloride Extended-Release Tablets, USP (SR), for oral use Initial U.S. Approval: 1985
64679-101-052025-12-19These highlights do not include all the information needed to use bupropion hydrochloride extended-release tablets (SR) safely and effectively. See full prescribing information for bupropion hydrochloride extended-release tablets (SR). Bupropion Hydrochloride Extended-Release Tablets, USP (SR), for oral use Initial U.S. Approval: 1985
64679-101-072025-12-19These highlights do not include all the information needed to use bupropion hydrochloride extended-release tablets (SR) safely and effectively. See full prescribing information for bupropion hydrochloride extended-release tablets (SR). Bupropion Hydrochloride Extended-Release Tablets, USP (SR), for oral use Initial U.S. Approval: 1985
64679-101-012023-01-30These highlights do not include all the information needed to use bupropion hydrochloride extended-release tablets (SR) safely and effectively. See full prescribing information for bupropion hydrochloride extended-release tablets (SR). Bupropion Hydrochloride Extended-Release Tablets, USP (SR), for oral use Initial U.S. Approval: 1985
64679-101-022023-01-30These highlights do not include all the information needed to use bupropion hydrochloride extended-release tablets (SR) safely and effectively. See full prescribing information for bupropion hydrochloride extended-release tablets (SR). Bupropion Hydrochloride Extended-Release Tablets, USP (SR), for oral use Initial U.S. Approval: 1985
64679-101-032023-01-30These highlights do not include all the information needed to use bupropion hydrochloride extended-release tablets (SR) safely and effectively. See full prescribing information for bupropion hydrochloride extended-release tablets (SR). Bupropion Hydrochloride Extended-Release Tablets, USP (SR), for oral use Initial U.S. Approval: 1985
64679-101-052023-01-30These highlights do not include all the information needed to use bupropion hydrochloride extended-release tablets (SR) safely and effectively. See full prescribing information for bupropion hydrochloride extended-release tablets (SR). Bupropion Hydrochloride Extended-Release Tablets, USP (SR), for oral use Initial U.S. Approval: 1985
64679-101-072023-01-30These highlights do not include all the information needed to use bupropion hydrochloride extended-release tablets (SR) safely and effectively. See full prescribing information for bupropion hydrochloride extended-release tablets (SR). Bupropion Hydrochloride Extended-Release Tablets, USP (SR), for oral use Initial U.S. Approval: 1985

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64679-101BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]4Legacy NDC20191128_3ff63de9-3750-46b9-829e-76e6f7b33542.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64679-101-02EA - Each64679-1019f7d9cd6-2eeb-42c8-bdfb-3d1f9b5fdc2912013-02-13
64679-101-03EA - Each64679-1017d4c6ad1-00ef-44df-be4d-2f038fbf0cc612013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]2
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]2
AMMONIUM CHLORIDEINACTIVE INGREDIENT01Q9PC255DBUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKBUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]2
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PBUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ABUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UBUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]2

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 87 of 142 · 2,835 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PRIDICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFURHyland's Inc.d22eca2f-d7e6-3412-e053-2995a90a63842025-02-05WarningsExact identifier
unii: ETJ7Z6XBU4
Jacksons Cell Salts 12 IN 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAZettl Health Inc.25ba49d0-0369-3666-e063-6294a90a71c42025-02-04Exact identifier
unii: ETJ7Z6XBU4
Jacksons Cell Salts SILICA 6X 12SILICEAZettl Health Inc.2d5d1bf7-3754-1f60-e063-6294a90aee062025-02-04Exact identifier
unii: ETJ7Z6XBU4
Brush On Block Sun Shine SPF 30 Protective Lip Oil Peony TintTITANIUM DIOXIDE/ZINC OXIDESPF Ventures LLC2d490531-af36-87d0-e063-6394a90acf492025-02-03WarningsExact identifier
unii: 15FIX9V2JP
PAULAS CHOICE HYDRALIGHT SHINE-FREE DAILY MINERAL COMPLEX Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEPaula's Choice, Incb90658d0-e422-4265-a6ee-39c29b6c116a2025-01-31WarningsExact identifier
unii: 15FIX9V2JP
SunStation USA SPF-30 SPORT SUNSCREENZINC OXIDERENU LABORATORIES, LLC11d3c60e-238d-999e-e063-6394a90a624b2025-01-31WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF30TITANIUM DIOXIDE AND ZINC OXIDEDERM ASSO. MID OHIO2d04bc5d-6f11-4f56-e063-6294a90ae7552025-01-31WarningsExact identifier
unii: 15FIX9V2JP
TiZO Mineral Sun Defense SPF 50TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.2d0766a1-4091-e84a-e063-6394a90a004a2025-01-31WarningsExact identifier
unii: 15FIX9V2JP
COVER plus CORRECT/TINTED MOISTURIZER CC CRM FAIROCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDEBluemercury5c590aed-d2f2-4478-8919-37c848752b422025-01-29WarningsExact identifier
unii: 15FIX9V2JP
LiProtect SPF 35ZINC OXIDE, TITANIUM DIOXIDEScience of Skincare0d0a2657-4098-3c60-e063-6294a90acabb2025-01-29WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEBELLE MEDICAL LLC2cdc69d3-2192-7a38-e063-6294a90a257f2025-01-29WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEBoxbar Beauty LLC2d04c5e7-f3aa-873f-e063-6294a90a33d22025-01-29WarningsExact identifier
unii: 15FIX9V2JP
ConstipationECHINACEA, IRIS VERSICOLOR, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ABIES NIGRA, AESCULUS HIPPOCASTANUM, ALOE, ALUMINA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLLINSONIA CANADENSIS, GRAPHITE, HYDRASTIS CANADENSIS 15X, KALI CARBONICUM 15X, LYCOPODIUM CLAVATUM 15X, MAGNESIA MURIATICA 15X, MEZEREUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHAMNUS PURSHIANA, SANICULA, SELENIUM METALLICUM, SEPIA, SILICEA, TABACUM, VERATRUM ALBUM, ZINCUM METALLICUMNewton Laboratories, Inc.9d63b107-cd47-d9a5-e053-2a95a90a44932025-01-28WarningsExact identifier
unii: ETJ7Z6XBU4
TiZO Mineral Sun Defense SPF 50TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.2cc8f7ef-eda3-fe71-e063-6394a90a6a9a2025-01-28WarningsExact identifier
unii: 15FIX9V2JP
Bupropion hydrochlorideBUPROPION HYDROCHLORIDECoupler LLC2ccbf988-64b6-3a60-e063-6394a90ababa2025-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEZ&Z Skin Essentials2cdc48f3-474f-9c06-e063-6294a90afea12025-01-27WarningsExact identifier
unii: 15FIX9V2JP
Cetaphil Sheer Mineral Sunscreen Stick SPF 50TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.54f6df65-e90c-4070-aa95-f47496dd11bd2025-01-27WarningsExact identifier
unii: 15FIX9V2JP
Bestmade Natural Products BM55DAPHNE INDICA, NATRUM PHOS, SILICA MARINA, TABACUMBestmade Natural Products2c751942-5b36-8558-e063-6294a90af87a2025-01-24WarningsExact identifier
unii: ETJ7Z6XBU4
ConstipationECHINACEA, IRIS VERSICOLOR, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ABIES NIGRA, AESCULUS HIPPOCASTANUM, ALOE, ALUMINA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLLINSONIA CANADENSIS, GRAPHITE, HYDRASTIS CANADENSIS 15X, KALI CARBONICUM 15X, LYCOPODIUM CLAVATUM 15X, MAGNESIA MURIATICA 15X, MEZEREUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHAMNUS PURSHIANA, SANICULA, SELENIUM METALLICUM, SEPIA, SILICEA, TABACUM, VERATRUM ALBUM, ZINCUM METALLICUMNewton Laboratories, Inc.9d626292-7abb-1afb-e053-2995a90a28182025-01-24WarningsExact identifier
unii: ETJ7Z6XBU4
CoTZ Silky Foam - TintedTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTDd63088d7-a1d7-4b56-a7d8-ad217011a8a82025-01-24WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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