NDC 55648-101-08 - 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: 55648-101
Requested NDC: 55648-101-08
Package NDCs from labels: 55648-101-01, 55648-101-02, 55648-101-03, 55648-101-07, 55648-101-08, 55648-101-05
Manufacturer: Wockhardt Limited
Effective date: 2012-11-06
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 Limited	Wockhardt Limited	2012-11-06	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
55648-101-01	PRESCRIBING INFORMATION Bupropion Hydrochloride Extended-Release Tablets, USP (SR)
55648-101-02	PRESCRIBING INFORMATION Bupropion Hydrochloride Extended-Release Tablets, USP (SR)
55648-101-03	PRESCRIBING INFORMATION Bupropion Hydrochloride Extended-Release Tablets, USP (SR)
55648-101-05	PRESCRIBING INFORMATION Bupropion Hydrochloride Extended-Release Tablets, USP (SR)
55648-101-07	PRESCRIBING INFORMATION Bupropion Hydrochloride Extended-Release Tablets, USP (SR)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55648-101-01	Bupropion Hydrochloride(SR)	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30	2
55648-101-02	Bupropion Hydrochloride(SR)	60 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	60	2
55648-101-03	Bupropion Hydrochloride(SR)	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100	2
55648-101-05	Bupropion Hydrochloride(SR)	10 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	10	2
55648-101-07	Bupropion Hydrochloride(SR)	500 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	500	2
55648-101-08	Bupropion Hydrochloride(SR)	10 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	10	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55648-101	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]	2	Legacy NDC, 6 package rows	20121107_1a2a5385-ec04-448f-8bdb-d1cc3eb5f1c0.zip

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 LIMITED]	2
BUPROPION	ACTIVE MOIETY	01ZG3TPX31	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]	2
AMMONIUM CHLORIDE	INACTIVE INGREDIENT	01Q9PC255D	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]	2
GLYCERYL DIBEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]	2
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]	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 92 of 141 · 2,819 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
THEFACESHOP Cushion CC SPF 50 Apricot Beige Oil-Free	ENSULIZOLE, TITANIUM DIOXIDE	LG H&H Co., Ltd.	d309eebc-44f4-bce6-e053-2995a90a3bd2	2025-01-01	Warnings	Exact identifier unii: 15FIX9V2JP
THEFACESHOP Cushion CC SPF 50 Natural Beige Oil-Free	ENSULIZOLE, TITANIUM DIOXIDE	LG H&H Co., Ltd.	d30a3bcb-5113-0a85-e053-2995a90a3937	2025-01-01	Warnings	Exact identifier unii: 15FIX9V2JP
THEFACESHOP Natural Sun Oil-Free Sunscreen Broad Spectrum SPF 50	ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LG H&H Co., Ltd.	d30a9f96-f99b-4610-e053-2995a90a3f91	2025-01-01	Warnings	Exact identifier unii: 15FIX9V2JP
THEFACESHOP Cushion CC Total Cover SPF 50 Apricot Beige	ENSULIZOLE, TITANIUM DIOXIDE	LG H&H Co., Ltd.	d30a7ecc-ea54-d1b9-e053-2995a90a7017	2025-01-01	Warnings	Exact identifier unii: 15FIX9V2JP
THEFACESHOP Cushion CC Total Cover SPF 50 Natural Beige	ENSULIZOLE, TITANIUM DIOXIDE	LG H&H Co., Ltd.	d30a87b9-90f9-35b2-e053-2995a90aea2c	2025-01-01	Warnings	Exact identifier unii: 15FIX9V2JP
THEFACESHOP Natural Sun Long Lasting Sunscreen Broad Spectrum SPF 50	ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LG H&H Co., Ltd.	d30ab7a5-d38c-ba62-e053-2995a90a57fd	2025-01-01	Warnings	Exact identifier unii: 15FIX9V2JP
O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREEN	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	LG H&H Co., Ltd.	f8361aa8-c3ad-0c47-e053-6394a90a6ab0	2025-01-01	Warnings	Exact identifier unii: 15FIX9V2JP
Babience KIDS Sunscreen pinkfong BABY SHARK SPF 50	ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LG H&H Co., Ltd.	a4364c8d-8b74-130e-e053-2995a90ad1c1	2025-01-01	Warnings	Exact identifier unii: 15FIX9V2JP
Obagi Medical Physical Defense Broad Spectrum Mineral Sunscreen SPF 50 by SUZANOBAGIMD	TITANIUM DIOXIDE AND ZINC OXIDE	Obagi Cosmeceuticals LLC	ff95a7b7-3cb4-41b0-866d-69361354a0bc	2025-01-01	Warnings	Exact identifier unii: 15FIX9V2JP
Almay Healthy Biome Makeup Golden	HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Almay	2a94c0a2-8a4c-39b9-e063-6394a90acf8c	2024-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Almay Healthy Biome Makeup Light	HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Almay	2a948e37-0554-d953-e063-6394a90a75e6	2024-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Almay Healthy Biome Makeup Fair	HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Almay	2a947e1d-286f-a939-e063-6394a90a0719	2024-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Almay Healthy Biome Makeup Tan	HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Almay	2a94a668-24cb-e0f2-e063-6294a90a79d3	2024-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Almay Healthy Biome Makeup Medium	HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Almay	2a94c0a2-8a47-39b9-e063-6394a90acf8c	2024-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20	TITANIUM DIOXIDE, ZINC OXIDE	Almay, Inc.	2a962944-9155-9b70-e063-6294a90ac535	2024-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20 Medium	TITANIUM DIOXIDE, ZINC OXIDE	Almay, Inc.	2a96811c-3ea6-15bc-e063-6394a90ac3bd	2024-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Revlon Colorstay Liquid Makeup for Normal to Dry Skin	ZINC OXIDE, TITANIUM DIOXIDE MAKE-UP	Revlon Consumer Products Corp	414538d6-9108-54bf-e054-00144ff8d46c	2024-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Revlon Colorstay Preo and Protect Primer	TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE PRIMER	Revlon Consumer Products Corp	8eebf23e-7fce-dfc0-e053-2995a90ae322	2024-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Revlon PhotoReady BB Cream Skin Perfector	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE MAKE-UP	Revlon Consumer Products Corp	410ca372-4698-029d-e054-00144ff8d46c	2024-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Revlon Colorstay Liquid Makeup for Oily to Combination Skin	ZINC OXIDE, TITANIUM DIOXIDE MAKE-UP	Revlon Consumer Products Corp	410d1cb2-6c92-1ca3-e054-00144ff8d46c	2024-12-31	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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