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 75 of 142 · 2,835 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dolce and Gabbana Everlast Foundation SPF 20 33N DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Le249507c-d536-4c1d-a99d-857ca1e833d82025-08-29WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 32W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lba99edea-bf68-4118-8bb7-ea40322db46a2025-08-29WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 34W DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L3a239897-9850-417f-8c00-e810a52540c12025-08-29WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 36N DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lc495afc3-6486-4652-b743-958f28eccaca2025-08-29WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 35W DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L5440ed13-b07e-4c81-a407-d9ac68eaa4832025-08-29WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 37W DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L9b2c4567-fde7-4b76-9988-b2cba2d3747e2025-08-29WarningsExact identifier
unii: 15FIX9V2JP
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 2ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3d55291c-9d4c-85c3-e063-6394a90af3302025-08-27WarningsExact identifier
unii: 15FIX9V2JP
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 3ENSULIZOLE ,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3d565612-ade5-bfb3-e063-6294a90a0c652025-08-27WarningsExact identifier
unii: 15FIX9V2JP
Sun Bum 30 Mineral Tinted Sunscreen FaceTITANIUM DIOXIDE, ZINC OXIDESun Bum, LLC3a290aad-7f40-cb10-e063-6394a90a2e692025-08-27WarningsExact identifier
unii: 15FIX9V2JP
OsmitrolMANNITOLBaxter Healthcare Company0d914965-7001-45cb-ba51-d7c5964b05bc2025-08-26Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDENuCare Pharmaceuticals,Inc.eeb3fed1-2202-09fc-e053-2995a90a9f632025-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepackf566f8b5-b3c1-4234-88bd-59a7b8dc801a2025-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepackfa5fa0d8-d27f-44e1-8868-dfa7206524e22025-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Allergy and Sinus ReliefPELARGONIUM SIDOIDES ROOT, HYDRASTIS CANADENSIS WHOLE, POTASSIUM CHLORIDE, SANGUINARIA CANADENSIS ROOT, PULSATILLA VULGARIS, SILICON DIOXIDESchwabe North American, Inc.c90cc6f5-14ec-41a3-a20a-4e8018bb02fb2025-08-25WarningsExact identifier
unii: ETJ7Z6XBU4
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 6ENSULIZOLE ,HOMOSALATE ,OCTINOXATE,TITANIUM DIOXIDELongway Technology(Guangzhou) Co., Ltd.3d0359b6-088f-aa54-e063-6394a90a422f2025-08-23WarningsExact identifier
unii: 15FIX9V2JP
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 4ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDELongway Technology(Guangzhou) Co., Ltd.3cdc1ae9-2924-5057-e063-6294a90ad2f32025-08-21WarningsExact identifier
unii: 15FIX9V2JP
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 3ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDELongway Technology(Guangzhou) Co., Ltd.3b21f1d8-534d-f4ea-e063-6294a90ad2eb2025-08-21WarningsExact identifier
unii: 15FIX9V2JP
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 5ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDELongway Technology(Guangzhou) Co., Ltd.3ceb3368-439c-9f6c-e063-6294a90a98ba2025-08-21WarningsExact identifier
unii: 15FIX9V2JP
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 2ENSULIZOLE ,HOMOSALATE ,OCTINOXATE,TITANIUM DIOXIDELongway Technology(Guangzhou) Co., Ltd.3cc8b151-c07d-7473-e063-6294a90a1cc72025-08-20WarningsExact identifier
unii: 15FIX9V2JP
SEYEZINC OXIDE AND TITANIUM DIOXIDE CREAMGuangzhou Seye Biomedical Technology Co., Ltd.3cce91b1-311b-4c95-e063-6294a90a2d7a2025-08-20WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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