Bupropion Hydrochloride

Product NDC: 50228-338
11-digit product format: 502280338
Labeler code: 50228
Product ID: 50228-338_d9b7b0d0-71db-578b-e053-2a95a90a8514
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bupropion hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: ScieGen Pharmaceuticals, Inc.
Application: ANDA206122
Marketing category: ANDA
Marketing start: 2019-05-01
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 · 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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Bupropion Hydrochloride
Brand name suffix: (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
2bb61b34-653a-43b4-9682-705d5b82d18e	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
50228-338-11	Bupropion Hydrochloride(SR)	1000 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	1000	7
50228-338-31	Bupropion Hydrochloride(SR)	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	30	7
50228-338-61	Bupropion Hydrochloride(SR)	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	60	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50228-338	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SCIEGEN PHARMACEUTICALS, INC.]	7	Current NDC, Legacy NDC, 3 package rows	20220309_2bb61b34-653a-43b4-9682-705d5b82d18e.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 · 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
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 ndc (product): 50228-338

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	2bb61b34-653a-43b4-9682-705d5b82d18e	7
1801289	Smoking Cessation 12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	2bb61b34-653a-43b4-9682-705d5b82d18e	7
1801289	bupropion HCl 150 MG Smoking Cessation 12 HR Extended Release Oral Tablet	SY	2bb61b34-653a-43b4-9682-705d5b82d18e	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50228-338-11	50228033811	1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-338-11)	2019-05-01	0000-00-00	No	No	Current
50228-338-31	50228033831	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-338-31)	2019-05-01	0000-00-00	No	No	Current
50228-338-61	50228033861	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-338-61)	2019-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bupropion Hydrochloride (SR)	ScieGen Pharmaceuticals, Inc. \| ScieGen Pharmaceuticals, Inc	2022-03-08	HUMAN PRESCRIPTION DRUG LABEL	7