BuPROPion Hydrochloride

Product NDC: 68084-708
11-digit product format: 680840708
Labeler code: 68084
Product ID: 68084-708_2527fdf4-c142-f5aa-e063-6294a90ae2e6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bupropion hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: American Health Packaging
Application: ANDA079095
Marketing category: ANDA
Marketing start: 2015-04-01
Substance: BUPROPION HYDROCHLORIDE
Active strength: 150 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: 2026-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A079095-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24
A079095-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24
A079095-003	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079095-001	AB1
A079095-002	AB1
A079095-003	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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A079095-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079095-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079095-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079095-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079095-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079095-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079095-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079095-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079095-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079095-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079095-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079095-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079095-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079095-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079095-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079095-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079095-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079095-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079095-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079095-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079095-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079095-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079095-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079095-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079095-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079095-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079095-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079095-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079095-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079095-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079095-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079095-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079095-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079095-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079095-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079095-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079095-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079095-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079095-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079095-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2009-03-24	`8072bd15b7f6…`

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	A079095-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079095-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079095-003	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079095-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079095-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079095-003	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079095-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079095-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079095-003	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079095-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079095-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079095-003	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079095-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079095-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079095-003	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079095-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079095-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079095-003	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079095-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079095-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079095-003	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079095-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079095-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079095-003	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079095-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079095-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079095-003	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079095-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079095-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079095-003	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079095-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079095-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079095-003	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079095-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079095-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079095-003	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079095-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079095-002	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079095-003	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079095-001	AB1	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: BuPROPion Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUPROPION HYDROCHLORIDE	150 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
993503	Internal RxNorm lookup
993518	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
1af890f7-1db8-4dd2-bf66-2b1e0c93a3d8	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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68084-708-25	BuPROPion Hydrochloride	30 in 1 BOX, UNIT-DOSE	TABLET, FILM COATED, EXTENDED RE	30		11
68084-708-95	BuPROPion Hydrochloride	1 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	1		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68084-708-25	EA - Each	68084-708	e4556477-21d0-4dda-8995-92e98e5b6cdb	1	2015-05-05
68084-708-95	EA - Each	68084-708	cccc0043-3946-430d-8c72-5c73ba92d5de	1	2015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BUPROPION HYDROCHLORIDE	ACTIVE INGREDIENT	ZG7E5POY8O	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
BUPROPION	ACTIVE MOIETY	01ZG3TPX31	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68084-708	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	11	Current NDC, Legacy NDC, 2 package rows	20241027_1af890f7-1db8-4dd2-bf66-2b1e0c93a3d8.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BuPROPion Hydrochloride	BUPROPION HYDROCHLORIDE	American Health Packaging	1af890f7-1db8-4dd2-bf66-2b1e0c93a3d8	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079095 application number: ANDA079095 ndc (product): 68084-708
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	f58ce435-b124-4519-98d8-de2d00f61b01	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079095 application number: ANDA079095
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Actavis Pharma, Inc.	cec41945-8d64-4793-8784-4c2b8ec37b0f	2025-11-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079095 application number: ANDA079095
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	ec8c699f-a8de-4e5a-a223-8de3f5dfe20d	2024-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079095 application number: ANDA079095
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Proficient Rx LP	b59d950c-341f-45f1-b5b2-d64ccc799580	2024-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079095 application number: ANDA079095
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Proficient Rx LP	13770e60-117c-4814-93bb-9bc41a042a20	2022-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079095 application number: ANDA079095
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Proficient Rx LP	a165869a-9bc4-4987-babe-a77fad78c38f	2020-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079095 application number: ANDA079095

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	1af890f7-1db8-4dd2-bf66-2b1e0c93a3d8	11
993518	buPROPion HCl 150 MG 12HR Extended Release Oral Tablet	PSN	1af890f7-1db8-4dd2-bf66-2b1e0c93a3d8	11
993503	12 HR bupropion hydrochloride 100 MG Extended Release Oral Tablet	SCD	1af890f7-1db8-4dd2-bf66-2b1e0c93a3d8	11
993518	12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	1af890f7-1db8-4dd2-bf66-2b1e0c93a3d8	11
993503	bupropion HCl 100 MG 12 HR Extended Release Oral Tablet	SY	1af890f7-1db8-4dd2-bf66-2b1e0c93a3d8	11
993518	bupropion HCl 150 MG 12 HR Extended Release Oral Tablet	SY	1af890f7-1db8-4dd2-bf66-2b1e0c93a3d8	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68084-708-25	68084070825	30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-708-25) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68084-708-95)	30 blister pack	2015-04-01	0000-00-00	No	No	Current
68084-708-95	68084070895	1 in 1 BLISTER PACK						Historical