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
Label	Manufacturer	Effective date	Type
Bupropion Hydrochloride (SR) - Wockhardt USA LLC. \| Wockhardt Limited	Wockhardt USA LLC. \| Wockhardt Limited	2019-11-26	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
64679-101-01	2025-12-19	These 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
64679-101-02	2025-12-19	These 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
64679-101-03	2025-12-19	These 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
64679-101-05	2025-12-19	These 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
64679-101-07	2025-12-19	These 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
64679-101-01	2023-01-30	These 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
64679-101-02	2023-01-30	These 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
64679-101-03	2023-01-30	These 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
64679-101-05	2023-01-30	These 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
64679-101-07	2023-01-30	These 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
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64679-101	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	4	Legacy NDC	20191128_3ff63de9-3750-46b9-829e-76e6f7b33542.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64679-101-02	EA - Each	64679-101	9f7d9cd6-2eeb-42c8-bdfb-3d1f9b5fdc29	1	2013-02-13
64679-101-03	EA - Each	64679-101	7d4c6ad1-00ef-44df-be4d-2f038fbf0cc6	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BUPROPION HYDROCHLORIDE	ACTIVE INGREDIENT	ZG7E5POY8O	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	2
BUPROPION	ACTIVE MOIETY	01ZG3TPX31	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	2
AMMONIUM CHLORIDE	INACTIVE INGREDIENT	01Q9PC255D	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	2
GLYCERYL DIBEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	2
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BUPROPION 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 15 of 145 · 2,886 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sei Bella Tinted BB Moisturizing Cream	410 N	PML NYC, LLC	316e97bc-4b96-ba6e-e063-6294a90a7648	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
EltaMD UV Restore Tinted	TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREEN	CP Skin Health Group, Inc.	6a48ad0d-20e4-44b1-90d6-30bfbc68a152	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
Pneumo HP	AMMONIUM MURIATICUM, ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, CALCAREA CARBONICA, LOBELIA INFLATA, NATRUM SULPHURICUM, SPONGIA TOSTA, PHOSPHORUS,	BioActive Nutritional, Inc.	532dd216-746c-4a56-98b4-cf90e2e509ac	2026-04-17	Warnings	Exact identifier unii: 01Q9PC255D
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Medium)	TITANIUM DIOXIDE, ZINC OXIDE	ZO Skin Health Inc.	4f95cd0a-f996-648b-e063-6294a90adc28	2026-04-16	Warnings	Exact identifier unii: 15FIX9V2JP
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Tan)	TITANIUM DIOXIDE, ZINC OXIDE	ZO Skin Health Inc.	4f968058-e851-86d0-e063-6294a90aa786	2026-04-16	Warnings	Exact identifier unii: 15FIX9V2JP
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Deep)	TITANIUM DIOXIDE, ZINC OXIDE	ZO Skin Health Inc.	4f970778-97d6-40a9-e063-6394a90a6c89	2026-04-16	Warnings	Exact identifier unii: 15FIX9V2JP
MELAO Hydrating Mineral Sunscreen	TITANIUM DIOXIDE,ZINC OXIDE	Guangdong Aimu Biological Technology Co., Ltd	4f778eb0-55f7-38d0-e063-6394a90a69a0	2026-04-15	Warnings	Exact identifier unii: 15FIX9V2JP
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45	TITANIUM DIOXIDE, ZINC OXIDE	ZO Skin Health Inc.	4f81e482-8111-451c-e063-6294a90ad148	2026-04-15	Warnings	Exact identifier unii: 15FIX9V2JP
Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	UNDRBUDR, LLC	4f8353b3-4ac1-9703-e063-6294a90abdad	2026-04-15	Warnings	Exact identifier unii: 15FIX9V2JP
Mineral Sunscreen Stick Non-Tinted	TITANIUM DIOXIDE, ZINC OXIDE	UNDRBUDR, LLC	4f83dd76-a8d8-916e-e063-6294a90ab6ed	2026-04-15	Warnings	Exact identifier unii: 15FIX9V2JP
Mineral Sunscreen Stick - Tinted	TITANIUM DIOXIDE, ZINC OXIDE	UNDRBUDR, LLC	4f84619f-3415-7443-e063-6394a90a162a	2026-04-15	Warnings	Exact identifier unii: 15FIX9V2JP
Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Ivory	TITANIUM DIOXIDE AND ZINC OXIDE	PML NYC, LLC	1be639a8-179a-7015-e063-6394a90ab64b	2026-04-15	Warnings	Exact identifier unii: 15FIX9V2JP
DD Cream Dermatologically Defining BB Cream Broad Spectrum SPF 30	DD CREAM DERMATOLOGICALLY DEFINING BB CREAM BROAD SPECTRUM SPF 30	PML NYC, LLC	ea90bb4d-6f4a-45c9-e053-2a95a90a53a7	2026-04-15	Warnings	Exact identifier unii: 15FIX9V2JP
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- ALABASTER	YOUR NAME MINERAL SHEER TINT	PML NYC, LLC	0e24a63e-d76f-6581-e063-6394a90a6181	2026-04-15	Warnings	Exact identifier unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Cream	115 N	PML NYC, LLC	316e8ac6-f8fa-7add-e063-6294a90a4f24	2026-04-15	Warnings	Exact identifier unii: 15FIX9V2JP
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Light)	TITANIUM DIOXIDE, ZINC OXIDE	ZO Skin Health Inc.	4f8756bf-5b0d-5269-e063-6294a90ae6dc	2026-04-15	Warnings	Exact identifier unii: 15FIX9V2JP
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Light Medium)	TITANIUM DIOXIDE, ZINC OXIDE	ZO Skin Health Inc.	4f87e24f-e4ff-03a7-e063-6294a90a23b1	2026-04-15	Warnings	Exact identifier unii: 15FIX9V2JP
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20 Cameo Glow	YOUR NAME MINERAL SHEER TINT	PML NYC, LLC	316cd602-8af5-fbb6-e063-6294a90a287b	2026-04-15	Warnings	Exact identifier unii: 15FIX9V2JP
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Cardinal Health 107, LLC	ec4d2256-0340-4166-90ee-c264eef3ac82	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: ZG7E5POY8O
BANANA BOAT	TITANIUM DIOXIDE,ZINC OXIDE	Edgewell Personal Care Brands LLC	4f5896a6-0639-5589-e063-6294a90a45a9	2026-04-13	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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