BUPROPION HYDROCHLORIDE (SR)

Product NDC: 43598-863
11-digit product format: 435980863
Labeler code: 43598
Product ID: 43598-863_4486fd29-bab2-59ee-e063-6294a90a4fd2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bupropion Hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Dr. Reddy's Laboratories Inc
Application: ANDA206122
Marketing category: ANDA
Marketing start: 2016-08-17
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A206122-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2016-08-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206122-001	AB2

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 · 41 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	A206122-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206122-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206122-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206122-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206122-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206122-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206122-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206122-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206122-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206122-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206122-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206122-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206122-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206122-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206122-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206122-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206122-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206122-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206122-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206122-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206122-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206122-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206122-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206122-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206122-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206122-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206122-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206122-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206122-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206122-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206122-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206122-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206122-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206122-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206122-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206122-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206122-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206122-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206122-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206122-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2016-08-17	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A206122-001	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206122-001	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206122-001	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206122-001	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206122-001	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206122-001	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206122-001	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206122-001	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206122-001	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206122-001	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206122-001	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206122-001	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206122-001	AB2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206122-001	AB2	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206122-001	AB2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206122-001	AB2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206122-001	AB2	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206122-001	AB2	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206122-001	AB2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206122-001	AB2	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206122-001	AB2	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206122-001	AB2	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206122-001	AB2	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206122-001	AB2	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206122-001	AB2	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206122-001	AB2	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206122-001	AB2	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206122-001	AB2	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206122-001	AB2	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206122-001	AB2	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206122-001	AB2	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206122-001	AB2	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206122-001	AB2	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206122-001	AB2	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206122-001	AB2	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206122-001	AB2	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206122-001	AB2	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206122-001	AB2	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206122-001	AB2	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206122-001	AB2	1	`cb3db0bc1861…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 HYDROCHLORIDE (SR)	BUPROPION HYDROCHLORIDE	Dr. Reddy's Laboratories Inc	8069c521-c49a-4b6d-baa8-4b0be897d585	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206122 application number: ANDA206122 ndc (product): 43598-863
BUPROPION HYDROCHLORIDE (SR)	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	994229b0-e190-49e3-83ce-6a2063f7335a	2025-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206122 application number: ANDA206122
Bupropion Hydrochloride (SR)	BUPROPION HYDROCHLORIDE	ScieGen Pharmaceuticals, Inc.	2bb61b34-653a-43b4-9682-705d5b82d18e	2022-03-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206122 application number: ANDA206122

Additional Listing Data#

Finished product: Yes
Brand name base: BUPROPION HYDROCHLORIDE (SR)
Listing expiration: 2026-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1801289	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
8069c521-c49a-4b6d-baa8-4b0be897d585	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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43598-863-10	BUPROPION HYDROCHLORIDE (SR)	1000 in 1 BOTTLE	TABLET, EXTENDED RELEASE	1000	6
43598-863-30	BUPROPION HYDROCHLORIDE (SR)	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	6
43598-863-60	BUPROPION HYDROCHLORIDE (SR)	60 in 1 BOTTLE	TABLET, EXTENDED RELEASE	60	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43598-863-60	EA - Each	43598-863	8888cb0f-ab2b-45df-b6fc-f272b8718f31	1	2019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43598-863	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES INC]	5	Current NDC, Legacy NDC, 3 package rows	20241031_8069c521-c49a-4b6d-baa8-4b0be897d585.zip

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
1801289	buPROPion HCl 150 MG Smoking Cessation 12HR Extended Release Oral Tablet	PSN	994229b0-e190-49e3-83ce-6a2063f7335a	12
1801289	Smoking Cessation 12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	994229b0-e190-49e3-83ce-6a2063f7335a	12
1801289	bupropion HCl 150 MG Smoking Cessation 12 HR Extended Release Oral Tablet	SY	994229b0-e190-49e3-83ce-6a2063f7335a	12
1801289	buPROPion HCl 150 MG Smoking Cessation 12HR Extended Release Oral Tablet	PSN	8069c521-c49a-4b6d-baa8-4b0be897d585	6
1801289	Smoking Cessation 12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	8069c521-c49a-4b6d-baa8-4b0be897d585	6
1801289	bupropion HCl 150 MG Smoking Cessation 12 HR Extended Release Oral Tablet	SY	8069c521-c49a-4b6d-baa8-4b0be897d585	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43598-863-10	43598086310	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-863-10)	2016-08-17	0000-00-00	No	No	Current
43598-863-30	43598086330	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-863-30)	2016-08-17	0000-00-00	No	No	Current
43598-863-60	43598086360	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-863-60)	2016-08-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BUPROPION HYDROCHLORIDE (SR)	Dr. Reddy's Laboratories Inc \| ScieGen Pharmaceuticals, Inc	2025-10-01	HUMAN PRESCRIPTION DRUG LABEL	6
BUPROPION HYDROCHLORIDE (SR)	A-S Medication Solutions	2025-07-09	HUMAN PRESCRIPTION DRUG LABEL	12
BUPROPION HYDROCHLORIDE (SR)	REMEDYREPACK INC.	2021-09-15	HUMAN PRESCRIPTION DRUG LABEL	4