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 86 of 142 · 2,835 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bestmade Natural Products BM127CALC CARB, LYCOPODIUM, SENEGA, SILICEA, STICTA PULM, YERBA SANTABestmade Natural Products2dcc5468-9b11-b6d5-e063-6294a90a41392025-02-10WarningsExact identifier
unii: ETJ7Z6XBU4
12 CELL SALTS COMPLEXCALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SILICEASEVENE USAff0f69cd-97a2-7183-e053-6394a90ad0392025-02-10WarningsExact identifier
unii: ETJ7Z6XBU4
SILICEA 200ckSILICEASEVENE USAcf89bb22-9e2f-9143-e053-2995a90aff192025-02-10WarningsExact identifier
unii: ETJ7Z6XBU4
Artistry Ideal Radiance Illuminating CC SPF 50 Broad Spectrum Sunscreen DeepENSULIZOLE, OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDEAmway Corp88021a24-d3b5-48f8-8d26-affbfcfd098f2025-02-10WarningsExact identifier
unii: 15FIX9V2JP
Teeth-GumsCHAMOMILLA, ECHINACEA, ACONITUM NAPELLUS, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA, CALENDULA OFFICINALIS, CHAMOMILLA, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, MERCURIUS VIVUS, MYRRHA, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PLANTAGO MAJOR, RHUS TOXICODENDRON, SILICEA, STAPHYSAGRIANewton Laboratories, Inc.9d27b1e4-a966-5495-e053-2a95a90a965b2025-02-10WarningsExact identifier
unii: ETJ7Z6XBU4
Teeth-GumsCHAMOMILLA, ECHINACEA, ACONITUM NAPELLUS, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA, CALENDULA OFFICINALIS, CHAMOMILLA, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, MERCURIUS VIVUS, MYRRHA, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PLANTAGO MAJOR, RHUS TOXICODENDRON, SILICEA, STAPHYSAGRIANewton Laboratories, Inc.9d363a40-a17b-2b6f-e053-2a95a90a33842025-02-10WarningsExact identifier
unii: ETJ7Z6XBU4
Dust-Mold-DanderIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ANTIMONIUM CRUDUM, APIS MELLIFICA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BLATTA ORIENTALIS, BROMIUM, BRYONIA, CANDIDA ALBICANS, CARDUUS BENEDICTUS, CAT HAIR, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, DOG HAIR, HISTAMINUM HYDROCHLORICUM, HOUSE DUST, IPECACUANHA, LYCOPODIUM CLAVATUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHUS TOXICODENDRON, SECALE CORNUTUM, SILICEA, USTILAGO MAIDIS, TORULA CEREVISIAE.Newton Laboratories, Inc.99fdc906-3a55-e4c4-e053-2a95a90a76ba2025-02-10WarningsExact identifier
unii: ETJ7Z6XBU4
Sun Defense Minerals (Sheer)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2dd20800-2cf9-02d4-e063-6294a90a0f002025-02-10WarningsExact identifier
unii: 15FIX9V2JP
Centella Calming SUNSCREENCENTELLA CALMING SUNSCREENGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd2dc0ee9b-d58b-fe40-e063-6394a90af4392025-02-09WarningsExact identifier
unii: 15FIX9V2JP
PROBIOTIC RICE SunscreenPROBIOTIC RICE SUNSCREENGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd2d9d6440-39b3-312a-e063-6394a90aa0722025-02-08WarningsExact identifier
unii: 15FIX9V2JP
Leg Cramps-SwellingECHINACEA, ARGENTUM NITRICUM, BRYONIA, CALCAREA CARBONICA, COLOCYNTHIS, CONVALLARIA MAJALIS, CROTALUS HORRIDUS, CUPRUM METALLICUM, DIGITALIS , GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, LATHYRUS SATIVUS, LILIUM TIGRINUM, MAGNESIA PHOSPHORICA, NUX VOMICA, RHUS TOXICODENDRON, SILICEA, STRAMONIUM, VERATRUM VIRIDE, ELAPSNewton Laboratories, Inc.9c315126-e61e-f649-e053-2a95a90a7f082025-02-07WarningsExact identifier
unii: ETJ7Z6XBU4
Dust-Mold-DanderIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ANTIMONIUM CRUDUM, APIS MELLIFICA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BLATTA ORIENTALIS, BROMIUM, BRYONIA, CANDIDA ALBICANS, CARDUUS BENEDICTUS, CAT HAIR, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, DOG HAIR, HISTAMINUM HYDROCHLORICUM, HOUSE DUST, IPECACUANHA, LYCOPODIUM CLAVATUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHUS TOXICODENDRON, SECALE CORNUTUM, SILICEA, USTILAGO MAIDIS, TORULA CEREVISIAE.Newton Laboratories, Inc.9bb84bae-9019-ed76-e053-2a95a90a5c3e2025-02-06WarningsExact identifier
unii: ETJ7Z6XBU4
Dust-Mold-DanderIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ANTIMONIUM CRUDUM, APIS MELLIFICA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BLATTA ORIENTALIS, BROMIUM, BRYONIA, CANDIDA ALBICANS, CARDUUS BENEDICTUS, CAT HAIR, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, DOG HAIR, HISTAMINUM HYDROCHLORICUM, HOUSE DUST, IPECACUANHA, LYCOPODIUM CLAVATUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHUS TOXICODENDRON, SECALE CORNUTUM, SILICEA, USTILAGO MAIDIS, TORULA CEREVISIAE.Newton Laboratories, Inc.9ba993f4-97af-4119-e053-2995a90a126d2025-02-06WarningsExact identifier
unii: ETJ7Z6XBU4
Ear Wax Build-UpELAPS CORALLINUS, ALUMINA, CARBO VEG., CAUSTICUM, CONIUM, GRAPHITES, KALI BIC.,KALI MUR., LACHESIS, LYCOPODIUM, PETROLEUM, PULSATILLA, SABADILLA, SEPIA, SILICEA, SPONGIA, VERBASCUM, VIOLA ODORATANewton Laboratories, Inc.9302b838-6003-ba6a-e053-2995a90aedd32025-02-06WarningsExact identifier
unii: ETJ7Z6XBU4
DR.JART CICAPAIR TIGER GRASS COLOR CORRECTING TREATMENTZINC OXIDE, TITANIUM DIOXIDEHave & Be Co., Ltd.01cfe6a6-c2e4-8fb8-e063-6294a90adc782025-02-06WarningsExact identifier
unii: 15FIX9V2JP
Dr.Jart Premium Beauty Balm Medium-TanZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.02a8bab8-ca5d-6b65-e063-6294a90abb072025-02-06WarningsExact identifier
unii: 15FIX9V2JP
Dr.Jart Premium Beauty Balm Fair-LightZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.02a82029-bdb1-cbe0-e063-6294a90a08f32025-02-06WarningsExact identifier
unii: 15FIX9V2JP
Dr.Jart Premium Beauty Balm Light Medium-MediumZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.02a87c6b-3c7d-5942-e063-6294a90aa4522025-02-06WarningsExact identifier
unii: 15FIX9V2JP
DR.JART EVERY SUN DAY MINERAL SUN SCREENTITANIUM DIOXIDE, ZINC OXIDEHave & Be Co., Ltd.02a671ed-485d-d6b7-e063-6394a90ad4af2025-02-06WarningsExact identifier
unii: 15FIX9V2JP
Dr.Jart Cicapair Tiger Grass Camo DropsZINC OXIDE, TITANIUM DIOXIDEHave & Be Co., Ltd.01cf0522-a3c1-aea8-e063-6294a90aabfe2025-02-06WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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