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 77 of 142 · 2,835 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dolce and Gabbana Everlast Foundation SPF 20 25W Medium Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	c6f27df4-6de4-45e4-90cb-ea8b0d29dbd3	2025-08-11	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 26W Medium Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	968abacd-8b99-4529-a627-2b56cdf99e1b	2025-08-11	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 27N Medium Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	a9068dc0-bc48-498b-adc9-57ff810384af	2025-08-11	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 28W Medium Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	37f01f66-c604-4fc3-a263-2089db91283f	2025-08-11	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 29W Medium Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	bca57893-bd2d-44ac-a503-2f11c3b62bf2	2025-08-11	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 30N Medium Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	37188b77-ab0b-4bea-b839-99e589600a2b	2025-08-11	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 31N Medium Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	c89e45d6-2322-4913-a557-e1780a86fd63	2025-08-11	Warnings	Exact identifier unii: 15FIX9V2JP
Cloveden Vegan Whitening Tooth	SILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATE	Acuseplanet Inc	3c04778b-9535-856e-e063-6294a90aa868	2025-08-10	Warnings	Exact identifier unii: ETJ7Z6XBU4
SUNSCREEN SPF50	ETHYLHEXYL METHOXYCINNAMATE, OCTOCRYLENE, TITANIUM DIOXIDE	Guangzhou Tinsun Biotechnology Company Limited	3bc1c6e9-1dd5-d7c6-e063-6394a90ad89e	2025-08-07	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 17W Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	053cb3cd-dd16-4d08-b347-a4349fa37c07	2025-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 14W Light Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	7bf90657-b636-41d6-b96c-88d174989f5b	2025-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 15N Light Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	da7e19cd-6a8b-47df-bfc9-2f0f11b7955c	2025-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 16N Light Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	f7a1d379-6de0-4be4-84a9-e0ebef332bef	2025-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 18N Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	671be8a6-51b7-45d2-9fff-c7736d2eea3e	2025-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 19W Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	9efa5db5-d774-4089-895c-9667eda0f11b	2025-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 20C Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	76232666-e23f-4842-bd0d-37819739ec3a	2025-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 21W Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	876b9a5d-dae3-47f1-9da6-b5e179fd28cd	2025-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
UV SOLUTIONS BRIGHTENING TINTED BROAD SPECTRUM SPF 50 SUNSCREEN NIACINAMIDE ANTIOXIDANTS	TITANIUM DIOXIDE AND ZINC OXIDE	CLINIQUE LABORATORIES LLC	3bba70e9-da29-f43b-e063-6294a90a08ef	2025-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS PEARL 40mL with Pink Algae SPF 50	TITANIUM OXIDE, ZINC OXIDE	NAKED SUNDAYS PTY LTD	0127f290-8c5e-4285-e063-6294a90ae128	2025-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
GR BB SPF 25	OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE	ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI	3b22579b-21ce-4b96-bd24-774ce35bf6f7	2025-08-06	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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