BUPROPION HYDROCHLORIDE

Product NDC: 16729-443
11-digit product format: 167290443
Labeler code: 16729
Product ID: 16729-443_4092a3ea-403d-7a91-e063-6394a90a8ddf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BUPROPION HYDROCHLORIDE
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Accord Healthcare Inc.
Application: ANDA210497
Marketing category: ANDA
Marketing start: 2018-11-08
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 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210497-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2018-10-31
A210497-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2018-10-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A210497-001	AB3
A210497-002	AB3

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 3 · 84 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
2026-08-18 06:07:40	2026-07	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A210497-001	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210497-002	AB3	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210497-001	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210497-002	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210497-001	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210497-002	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210497-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210497-002	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210497-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210497-002	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210497-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210497-002	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210497-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210497-002	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210497-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210497-002	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210497-001	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210497-002	AB3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210497-001	AB3	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210497-002	AB3	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210497-001	AB3	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210497-002	AB3	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210497-001	AB3	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210497-002	AB3	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210497-001	AB3	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210497-002	AB3	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210497-001	AB3	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210497-002	AB3	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210497-001	AB3	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210497-002	AB3	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210497-001	AB3	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210497-002	AB3	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210497-001	AB3	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210497-002	AB3	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210497-001	AB3	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210497-002	AB3	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210497-001	AB3	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210497-002	AB3	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210497-001	AB3	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210497-002	AB3	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: BUPROPION HYDROCHLORIDE
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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
993541	Internal RxNorm lookup
993557	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
34686e9d-c106-4276-8b47-7460cca8860e	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
16729-443-10	BUPROPION HYDROCHLORIDE	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	13
16729-443-15	BUPROPION HYDROCHLORIDE	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90	13
16729-443-16	BUPROPION HYDROCHLORIDE	500 in 1 BOTTLE	TABLET, EXTENDED RELEASE	500	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16729-443-10	EA - Each	16729-443	a559fd11-0424-47db-bdaf-54cf5c5a7755	1	2018-12-13
16729-443-15	EA - Each	16729-443	873ab4be-00e5-4ebc-bac3-6cb53df7271c	1	2018-12-13
16729-443-16	EA - Each	16729-443	27998e18-e690-4de4-84cf-2033787e96f8	1	2018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16729-443	BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACCORD HEALTHCARE INC.]	12	Current NDC, Legacy NDC, 3 package rows	20241127_34686e9d-c106-4276-8b47-7460cca8860e.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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	080853c0-fcab-4645-9ddc-4946e895ac5f	2026-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	82bcdd72-9146-4c8d-a8aa-f92015864605	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	42e228a2-25b3-44a6-8da7-6616ca44ac7f	2026-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ae3bcdf7-d7f3-4f07-8113-af08af20a0d4	2026-02-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Accord Healthcare Inc.	34686e9d-c106-4276-8b47-7460cca8860e	2025-10-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497 ndc (product): 16729-443
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	5dec4414-5595-46c9-ada9-3fbe98152040	2025-02-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	DIRECT RX	96d87edc-d12b-44b2-e053-2995a90a4e63	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	f8af7829-8b61-6785-e053-6294a90af052	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	29a6c6e3-f30f-6541-e063-6394a90ae11d	2024-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Quality Care Products, LLC	a225dbbb-86f0-4547-a1c8-68eb64cd6892	2024-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	BluePoint Laboratories	5ccec958-998d-43a1-86fb-eb2b5e697b77	2024-11-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	7c46d95a-26f6-4364-8197-9e564e3405f2	2024-08-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	a18b5460-fcbb-42dd-8b87-197d11a08928	2024-05-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	77b78d35-40f5-4713-8468-aa09a6c2925d	2024-05-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Proficient Rx LP	5d40e301-7e06-4ecd-b7c6-3d7ac6a134d2	2022-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Proficient Rx LP	42201f4a-8856-4499-8bc3-d18612b1ec34	2022-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497

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
993541	buPROPion HCl 150 MG 24HR Extended Release Oral Tablet	PSN	080853c0-fcab-4645-9ddc-4946e895ac5f	22
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	080853c0-fcab-4645-9ddc-4946e895ac5f	22
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	080853c0-fcab-4645-9ddc-4946e895ac5f	22
993503	buPROPion HCl 100 MG 12HR Extended Release Oral Tablet	PSN	96d87edc-d12b-44b2-e053-2995a90a4e63	18
993541	buPROPion HCl 150 MG 24HR Extended Release Oral Tablet	PSN	96d87edc-d12b-44b2-e053-2995a90a4e63	18
993557	buPROPion HCl 300 MG 24HR Extended Release Oral Tablet	PSN	96d87edc-d12b-44b2-e053-2995a90a4e63	18
993503	12 HR bupropion hydrochloride 100 MG Extended Release Oral Tablet	SCD	96d87edc-d12b-44b2-e053-2995a90a4e63	18
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	96d87edc-d12b-44b2-e053-2995a90a4e63	18
993557	24 HR bupropion hydrochloride 300 MG Extended Release Oral Tablet	SCD	96d87edc-d12b-44b2-e053-2995a90a4e63	18
993503	bupropion HCl 100 MG 12 HR Extended Release Oral Tablet	SY	96d87edc-d12b-44b2-e053-2995a90a4e63	18
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	96d87edc-d12b-44b2-e053-2995a90a4e63	18
993557	bupropion HCl XL 300 MG 24 HR Extended Release Oral Tablet	SY	96d87edc-d12b-44b2-e053-2995a90a4e63	18
993541	buPROPion HCl 150 MG 24HR Extended Release Oral Tablet	PSN	ae3bcdf7-d7f3-4f07-8113-af08af20a0d4	15
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	ae3bcdf7-d7f3-4f07-8113-af08af20a0d4	15
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	ae3bcdf7-d7f3-4f07-8113-af08af20a0d4	15
993541	buPROPion HCl 150 MG 24HR Extended Release Oral Tablet	PSN	34686e9d-c106-4276-8b47-7460cca8860e	13
993557	buPROPion HCl 300 MG 24HR Extended Release Oral Tablet	PSN	34686e9d-c106-4276-8b47-7460cca8860e	13
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	34686e9d-c106-4276-8b47-7460cca8860e	13
993557	24 HR bupropion hydrochloride 300 MG Extended Release Oral Tablet	SCD	34686e9d-c106-4276-8b47-7460cca8860e	13
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	34686e9d-c106-4276-8b47-7460cca8860e	13
993557	bupropion HCl XL 300 MG 24 HR Extended Release Oral Tablet	SY	34686e9d-c106-4276-8b47-7460cca8860e	13
993541	buPROPion HCl 150 MG 24HR Extended Release Oral Tablet	PSN	7c46d95a-26f6-4364-8197-9e564e3405f2	12
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	7c46d95a-26f6-4364-8197-9e564e3405f2	12
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	7c46d95a-26f6-4364-8197-9e564e3405f2	12
993541	buPROPion HCl 150 MG 24HR Extended Release Oral Tablet	PSN	77b78d35-40f5-4713-8468-aa09a6c2925d	9
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	77b78d35-40f5-4713-8468-aa09a6c2925d	9
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	77b78d35-40f5-4713-8468-aa09a6c2925d	9
993541	buPROPion HCl 150 MG 24HR Extended Release Oral Tablet	PSN	42e228a2-25b3-44a6-8da7-6616ca44ac7f	7
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	42e228a2-25b3-44a6-8da7-6616ca44ac7f	7
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	42e228a2-25b3-44a6-8da7-6616ca44ac7f	7
993541	buPROPion HCl 150 MG 24HR Extended Release Oral Tablet	PSN	f8af7829-8b61-6785-e053-6294a90af052	2
993541	buPROPion HCl 150 MG 24HR Extended Release Oral Tablet	PSN	df6093eb-2067-595f-e053-2995a90a5a6d	2
993541	buPROPion HCl 150 MG 24HR Extended Release Oral Tablet	PSN	d99d21b3-090d-4c4b-b152-30ccb9f46c40	2
993541	buPROPion HCl 150 MG 24HR Extended Release Oral Tablet	PSN	d21a792a-4556-bcc0-e053-2a95a90a3391	2
993541	buPROPion HCl 150 MG 24HR Extended Release Oral Tablet	PSN	42201f4a-8856-4499-8bc3-d18612b1ec34	2
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	f8af7829-8b61-6785-e053-6294a90af052	2
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	42201f4a-8856-4499-8bc3-d18612b1ec34	2
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	d21a792a-4556-bcc0-e053-2a95a90a3391	2
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	d99d21b3-090d-4c4b-b152-30ccb9f46c40	2
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	df6093eb-2067-595f-e053-2995a90a5a6d	2
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	f8af7829-8b61-6785-e053-6294a90af052	2
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	42201f4a-8856-4499-8bc3-d18612b1ec34	2
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	d21a792a-4556-bcc0-e053-2a95a90a3391	2
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	d99d21b3-090d-4c4b-b152-30ccb9f46c40	2
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	df6093eb-2067-595f-e053-2995a90a5a6d	2
993541	buPROPion HCl 150 MG 24HR Extended Release Oral Tablet	PSN	9af0fadd-0ef9-2317-e053-2a95a90a9a88	1
993541	buPROPion HCl 150 MG 24HR Extended Release Oral Tablet	PSN	29a6c6e3-f30f-6541-e063-6394a90ae11d	1
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	29a6c6e3-f30f-6541-e063-6394a90ae11d	1
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	9af0fadd-0ef9-2317-e053-2a95a90a9a88	1
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	9af0fadd-0ef9-2317-e053-2a95a90a9a88	1
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	29a6c6e3-f30f-6541-e063-6394a90ae11d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16729-443-10	16729044310	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-443-10)	2018-11-08	0000-00-00	No	No	Current
16729-443-15	16729044315	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-443-15)	2018-11-08	0000-00-00	No	No	Current
16729-443-16	16729044316	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-443-16)	2018-11-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	2026-07-24	HUMAN PRESCRIPTION DRUG LABEL	23
BUPROPION HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	2026-03-20	HUMAN PRESCRIPTION DRUG LABEL	7
BUPROPION HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	2026-02-25	HUMAN PRESCRIPTION DRUG LABEL	15
BUPROPION HYDROCHLORIDE	Accord Healthcare Inc. \| Intas Pharmaceuticals Ltd	2025-10-07	HUMAN PRESCRIPTION DRUG LABEL	13
BUPROPION	DIRECT RX	2025-01-22	HUMAN PRESCRIPTION DRUG LABEL	18
Bupropion HCL ER Tablets	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	2
BUPROPION HYDROCHLORIDE	Quality Care Products, LLC	2024-12-18	HUMAN PRESCRIPTION DRUG LABEL	3
BUPROPION HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	2024-12-18	HUMAN PRESCRIPTION DRUG LABEL	1
BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	2024-10-30	HUMAN PRESCRIPTION DRUG LABEL	10
BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	2024-08-29	HUMAN PRESCRIPTION DRUG LABEL	12
BUPROPION HYDROCHLORIDE	A-S Medication Solutions	2024-05-16	HUMAN PRESCRIPTION DRUG LABEL	9
BUPROPION HYDROCHLORIDE	RPK Pharmaceuticals, Inc.	2023-09-11	HUMAN PRESCRIPTION DRUG LABEL	2
BUPROPION HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	2023-07-17	HUMAN PRESCRIPTION DRUG LABEL	2
BUPROPION HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	2022-12-07	HUMAN PRESCRIPTION DRUG LABEL	2
BUPROPION HYDROCHLORIDE	Proficient Rx LP	2022-06-01	HUMAN PRESCRIPTION DRUG LABEL	2
BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	2021-12-23	HUMAN PRESCRIPTION DRUG LABEL	2
BUPROPION HYDROCHLORIDE	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2020-06-16	HUMAN PRESCRIPTION DRUG LABEL	2
BUPROPION HYDROCHLORIDE	medsource pharmaceuticals	2019-12-30	HUMAN PRESCRIPTION DRUG LABEL	1