WELLBUTRIN

Product NDC: 0173-0947
11-digit product format: 001730947
Labeler code: 0173
Product ID: 0173-0947_5ffc8b63-7d69-4f3a-bf05-a9c138724a91
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bupropion hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: GlaxoSmithKline LLC
Application: NDA020358
Marketing category: NDA
Marketing start: 1996-11-15
Substance: BUPROPION HYDROCHLORIDE
Active strength: 100 mg/1
Pharmacologic classes: Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020358-001	WELLBUTRIN SR	BUPROPION HYDROCHLORIDE	50MG	TABLET, EXTENDED RELEASE / ORAL			1996-10-04
N020358-002	WELLBUTRIN SR	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04
N020358-003	WELLBUTRIN SR	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04
N020358-004	WELLBUTRIN SR	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2002-06-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N020358-002	AB1
N020358-003	AB1
N020358-004	AB1

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020358-001	WELLBUTRIN SR	50MG	TABLET, EXTENDED RELEASE / ORAL			1996-10-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020358-002	WELLBUTRIN SR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020358-003	WELLBUTRIN SR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020358-004	WELLBUTRIN SR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2002-06-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020358-001	WELLBUTRIN SR	50MG	TABLET, EXTENDED RELEASE / ORAL			1996-10-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020358-002	WELLBUTRIN SR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020358-003	WELLBUTRIN SR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020358-004	WELLBUTRIN SR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2002-06-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020358-001	WELLBUTRIN SR	50MG	TABLET, EXTENDED RELEASE / ORAL			1996-10-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020358-002	WELLBUTRIN SR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020358-003	WELLBUTRIN SR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020358-004	WELLBUTRIN SR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2002-06-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020358-001	WELLBUTRIN SR	50MG	TABLET, EXTENDED RELEASE / ORAL			1996-10-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020358-002	WELLBUTRIN SR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020358-003	WELLBUTRIN SR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020358-004	WELLBUTRIN SR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2002-06-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020358-001	WELLBUTRIN SR	50MG	TABLET, EXTENDED RELEASE / ORAL			1996-10-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020358-002	WELLBUTRIN SR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020358-003	WELLBUTRIN SR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020358-004	WELLBUTRIN SR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2002-06-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020358-001	WELLBUTRIN SR	50MG	TABLET, EXTENDED RELEASE / ORAL			1996-10-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020358-002	WELLBUTRIN SR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020358-003	WELLBUTRIN SR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020358-004	WELLBUTRIN SR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2002-06-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020358-001	WELLBUTRIN SR	50MG	TABLET, EXTENDED RELEASE / ORAL			1996-10-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020358-002	WELLBUTRIN SR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020358-003	WELLBUTRIN SR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020358-004	WELLBUTRIN SR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2002-06-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020358-001	WELLBUTRIN SR	50MG	TABLET, EXTENDED RELEASE / ORAL			1996-10-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020358-002	WELLBUTRIN SR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020358-003	WELLBUTRIN SR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020358-004	WELLBUTRIN SR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2002-06-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020358-001	WELLBUTRIN SR	50MG	TABLET, EXTENDED RELEASE / ORAL			1996-10-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020358-002	WELLBUTRIN SR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020358-003	WELLBUTRIN SR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020358-004	WELLBUTRIN SR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2002-06-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020358-001	WELLBUTRIN SR	50MG	TABLET, EXTENDED RELEASE / ORAL			1996-10-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020358-002	WELLBUTRIN SR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020358-003	WELLBUTRIN SR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD	1996-10-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020358-004	WELLBUTRIN SR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2002-06-14	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020358-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020358-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020358-004	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020358-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020358-003	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020358-004	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020358-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020358-003	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020358-004	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020358-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020358-003	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020358-004	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020358-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020358-003	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020358-004	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020358-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020358-003	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020358-004	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020358-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020358-003	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020358-004	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020358-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020358-003	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020358-004	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020358-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020358-003	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020358-004	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020358-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020358-003	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020358-004	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020358-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020358-003	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020358-004	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020358-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020358-003	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020358-004	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020358-002	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020358-003	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020358-004	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020358-002	AB1	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: WELLBUTRIN
Brand name suffix: SR
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUPROPION HYDROCHLORIDE	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ZG7E5POY8O	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
993503	Internal RxNorm lookup
993511	Internal RxNorm lookup
993518	Internal RxNorm lookup
993528	Internal RxNorm lookup
993536	Internal RxNorm lookup
993537	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
cbc8c074-f080-4489-a5ae-207b5fadeba3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4eceb285-f3c7-4092-a21a-4c9f3169f20c	Product name	5	20260220
548ba7fd-fd0c-4a21-b2b0-d01bf93143b8	Product name	3	20240209
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
b8ee525f-67fb-39fb-91da-7e47ac54581d	Product name	5	20200611
2e254488-9fcb-41b3-a7c3-e2c9a3941b29	Product name	1	20200603
b4ff0805-126a-406d-9cae-fc34fd8e8889	Product name	1	20190711
98e65af1-f5d0-75d5-c930-f8a4ce4c3284	Product name	9	20190211
e4d463bc-c674-43cb-be06-82786f310d01	Product name	1	20150326
0916dcfb-331f-89b1-8eac-6f7dc76d82da	Product name	1	20140508
d7fc3d53-5a6c-de82-2808-1780f175f17e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0173-0947-55	2020-07-22	C162847	48780-1	ab0e2407-3411-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use WELLBUTRIN SR safely and effectively. See full prescribing information for WELLBUTRIN SR. WELLBUTRIN SR (bupropion hydrochloride) sustained-release tablets, for oral use Initial U.S. Approval: 1985
0173-0947-55	2020-07-22	C162847	48780-1	ab0e2407-3411-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use WELLBUTRIN SR safely and effectively. See full prescribing information for WELLBUTRIN SR. WELLBUTRIN SR (bupropion hydrochloride) sustained-release tablets, for oral use Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0173-0947-55	WELLBUTRINSR	60 in 1 BOTTLE	TABLET, FILM COATED	60		39

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0173-0947-55	EA - Each	0173-0947	7536908c-e747-44ea-94b2-d7b99309ad5d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
bupropion hydrochloride	ACTIVE INGREDIENT	ZG7E5POY8O	WELLBUTRIN SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]	20
bupropion	ACTIVE MOIETY	01ZG3TPX31	WELLBUTRIN SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]	20
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	WELLBUTRIN SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]	20
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	WELLBUTRIN SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]	20
CYSTEINE HYDROCHLORIDE	INACTIVE INGREDIENT	ZT934N0X4W	WELLBUTRIN SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]	20
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	WELLBUTRIN SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]	20
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	WELLBUTRIN SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]	20
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	WELLBUTRIN SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]	20
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	WELLBUTRIN SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]	20
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	WELLBUTRIN SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]	20
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	WELLBUTRIN SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]	20
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	WELLBUTRIN SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]	20
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	WELLBUTRIN SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]	20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0173-0947	WELLBUTRIN SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]	37	Current NDC, Legacy NDC, 1 package rows	20250522_cbc8c074-f080-4489-a5ae-207b5fadeba3.zip

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
WELLBUTRIN SR	BUPROPION HYDROCHLORIDE	GlaxoSmithKline LLC	cbc8c074-f080-4489-a5ae-207b5fadeba3	2025-11-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020358 application number: NDA020358 ndc (product): 0173-0947

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
ZG7E5POY8O	BUPROPION HYDROCHLORIDE	31677-93-7	BUPROPION HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
993503	buPROPion HCl 100 MG 12HR Extended Release Oral Tablet	PSN	cbc8c074-f080-4489-a5ae-207b5fadeba3	39
993518	buPROPion HCl 150 MG 12HR Extended Release Oral Tablet	PSN	cbc8c074-f080-4489-a5ae-207b5fadeba3	39
993536	buPROPion HCl 200 MG 12HR Extended Release Oral Tablet	PSN	cbc8c074-f080-4489-a5ae-207b5fadeba3	39
993511	Wellbutrin SR 100 MG 12HR Extended Release Oral Tablet	PSN	cbc8c074-f080-4489-a5ae-207b5fadeba3	39
993528	Wellbutrin SR 150 MG 12HR Extended Release Oral Tablet	PSN	cbc8c074-f080-4489-a5ae-207b5fadeba3	39
993537	Wellbutrin SR 200 MG 12HR Extended Release Oral Tablet	PSN	cbc8c074-f080-4489-a5ae-207b5fadeba3	39
993511	12 HR bupropion hydrochloride 100 MG Extended Release Oral Tablet [Wellbutrin]	SBD	cbc8c074-f080-4489-a5ae-207b5fadeba3	39
993528	12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet [Wellbutrin]	SBD	cbc8c074-f080-4489-a5ae-207b5fadeba3	39
993537	12 HR bupropion hydrochloride 200 MG Extended Release Oral Tablet [Wellbutrin]	SBD	cbc8c074-f080-4489-a5ae-207b5fadeba3	39
993503	12 HR bupropion hydrochloride 100 MG Extended Release Oral Tablet	SCD	cbc8c074-f080-4489-a5ae-207b5fadeba3	39
993518	12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	cbc8c074-f080-4489-a5ae-207b5fadeba3	39
993536	12 HR bupropion hydrochloride 200 MG Extended Release Oral Tablet	SCD	cbc8c074-f080-4489-a5ae-207b5fadeba3	39
993511	12 HR Wellbutrin 100 MG Extended Release Oral Tablet	SY	cbc8c074-f080-4489-a5ae-207b5fadeba3	39
993528	12 HR Wellbutrin 150 MG Extended Release Oral Tablet	SY	cbc8c074-f080-4489-a5ae-207b5fadeba3	39
993537	12 HR Wellbutrin 200 MG Extended Release Oral Tablet	SY	cbc8c074-f080-4489-a5ae-207b5fadeba3	39
993503	bupropion HCl 100 MG 12 HR Extended Release Oral Tablet	SY	cbc8c074-f080-4489-a5ae-207b5fadeba3	39
993518	bupropion HCl 150 MG 12 HR Extended Release Oral Tablet	SY	cbc8c074-f080-4489-a5ae-207b5fadeba3	39
993536	bupropion hydrochloride 200 MG 12 HR Extended Release Oral Tablet	SY	cbc8c074-f080-4489-a5ae-207b5fadeba3	39
993528	Wellbutrin 150 MG 12 HR Extended Release Oral Tablet	SY	cbc8c074-f080-4489-a5ae-207b5fadeba3	39
993511	Wellbutrin SR 100 MG 12 HR Extended Release Oral Tablet	SY	cbc8c074-f080-4489-a5ae-207b5fadeba3	39
993537	Wellbutrin SR 200 MG 12 HR Extended Release Oral Tablet	SY	cbc8c074-f080-4489-a5ae-207b5fadeba3	39

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0173-0947-55	00173094755	60 TABLET, FILM COATED in 1 BOTTLE (0173-0947-55)	1996-11-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
WELLBUTRIN SR	GlaxoSmithKline LLC	2025-11-05	HUMAN PRESCRIPTION DRUG LABEL	39
WELLBUTRIN SR	REMEDYREPACK INC.	2019-05-02	HUMAN PRESCRIPTION DRUG LABEL	4