BUPROPION HCl ER (XL)

Product NDC: 70756-830
Requested package NDC: 70756-830-16
11-digit product format: 707560830
Labeler code: 70756
Product ID: 70756-830_ee47c513-8459-4292-b727-111b0bd1dbcc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BUPROPION HCl ER
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Lifestar Pharma LLC
Application: NDA022497
Marketing category: NDA
Marketing start: 2026-05-01
Substance: BUPROPION HYDROCHLORIDE
Active strength: 450 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 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022497-001	FORFIVO XL	BUPROPION HYDROCHLORIDE	450MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2011-11-10

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022497-001	7674479	2028-08-23		Drug product	2011-11-28

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-11-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022497-001	7674479	2028-08-23	Drug product	2011-11-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022497-001	7674479	2028-08-23	Drug product	2011-11-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022497-001	7674479	2028-08-23	Drug product	2011-11-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022497-001	7674479	2028-08-23	Drug product	2011-11-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022497-001	7674479	2028-08-23	Drug product	2011-11-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: BUPROPION HCl ER (XL)
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUPROPION HYDROCHLORIDE	450 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1232585	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
df959e1b-3f6d-42cf-8521-fe03b5a4ceb8	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
70756-830-16	BUPROPION HCl ER (XL)	16000 in 1 BOX	TABLET, EXTENDED RELEASE	16000		1
70756-830-30	BUPROPION HCl ER (XL)	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30		1

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BUPROPION HCl ER (XL)	BUPROPION HCL ER	Lifestar Pharma LLC	df959e1b-3f6d-42cf-8521-fe03b5a4ceb8	2026-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022497 application number: NDA022497 ndc (package): 70756-830-16 ndc (product): 70756-830 ndc11 (package): 70756083016
Forfivo XL	BUPROPION HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	80b01182-dc94-4990-8ebb-55c306d7e536	2025-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022497 application number: NDA022497
bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	98d5977f-9b32-46db-bd36-a2c4d1b0710a	2025-08-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022497 application number: NDA022497

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
1232585	buPROPion HCl 450 MG 24HR Extended Release Oral Tablet	PSN	df959e1b-3f6d-42cf-8521-fe03b5a4ceb8	1
1232585	24 HR bupropion hydrochloride 450 MG Extended Release Oral Tablet	SCD	df959e1b-3f6d-42cf-8521-fe03b5a4ceb8	1
1232585	bupropion hydrochloride 450 MG 24 HR Extended Release Oral Tablet	SY	df959e1b-3f6d-42cf-8521-fe03b5a4ceb8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
70756-830-16	70756083016	16000 TABLET, EXTENDED RELEASE in 1 BOX (70756-830-16)	2026-05-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BUPROPION HCl ER (XL)	Lifestar Pharma LLC \| TWi Pharmaceuticals, Inc. \| Pillar5 Pharma Inc \| Reed-Lane, Inc.	2026-02-04	HUMAN PRESCRIPTION DRUG LABEL	1