Bupropion Hydrochloride

Product NDC: 82009-052
11-digit product format: 820090052
Labeler code: 82009
Product ID: 82009-052_83a2b271-e681-44ec-83b2-c9e596e7ee05
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bupropion Hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Quallent Pharmaceuticals Health LLC
Application: ANDA090693
Marketing category: ANDA
Marketing start: 2023-07-07
Substance: BUPROPION HYDROCHLORIDE
Active strength: 300 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 1.

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
A090693-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2017-04-06
A090693-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2017-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090693-001	AB3
A090693-002	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 · 82 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	A090693-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090693-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090693-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090693-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090693-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090693-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090693-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090693-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090693-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090693-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090693-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090693-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090693-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090693-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090693-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090693-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090693-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090693-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090693-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090693-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090693-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090693-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090693-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090693-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090693-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090693-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090693-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090693-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090693-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090693-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090693-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090693-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090693-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090693-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090693-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090693-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090693-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090693-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090693-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090693-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A090693-001	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090693-002	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090693-001	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090693-002	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090693-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090693-002	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090693-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090693-002	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090693-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090693-002	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090693-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090693-002	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090693-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090693-002	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090693-001	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090693-002	AB3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090693-001	AB3	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090693-002	AB3	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090693-001	AB3	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090693-002	AB3	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090693-001	AB3	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090693-002	AB3	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090693-001	AB3	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090693-002	AB3	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090693-001	AB3	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090693-002	AB3	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090693-001	AB3	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090693-002	AB3	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090693-001	AB3	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090693-002	AB3	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090693-001	AB3	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090693-002	AB3	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090693-001	AB3	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090693-002	AB3	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090693-001	AB3	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090693-002	AB3	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090693-001	AB3	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090693-002	AB3	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090693-001	AB3	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090693-002	AB3	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Bupropion Hydrochloride
Brand name suffix: XL
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUPROPION HYDROCHLORIDE	300 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
56df4e22-81ca-48a4-a8e2-038448417355	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	Strength	SPL version
82009-052-05	Bupropion HydrochlorideXL	500 in 1 BOTTLE	TABLET, EXTENDED RELEASE	500		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82009-052-05	EA - Each	82009-052	e66a8c82-db8e-4414-994c-635718525123	1	2023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82009-052	BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [QUALLENT PHARMACEUTICALS HEALTH LLC]	2	Current NDC, 1 package rows	20241017_56df4e22-81ca-48a4-a8e2-038448417355.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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Major Pharmaceuticals	aa3d3e5b-74a3-47f6-b9aa-d6e248e950e5	2026-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090693 application number: ANDA090693
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	740534d3-59b5-4938-8e38-16275a14438c	2026-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090693 application number: ANDA090693
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	1af14d2e-c64d-44b7-a402-8869e8e30661	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090693 application number: ANDA090693
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Coupler LLC	512b0ed3-db7d-b273-e063-6394a90a25cc	2026-05-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090693 application number: ANDA090693
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	bcbef1b4-a135-4231-bc65-7d0b335260e8	2026-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090693 application number: ANDA090693
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Quallent Pharmaceuticals Health LLC	56df4e22-81ca-48a4-a8e2-038448417355	2026-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090693 application number: ANDA090693 ndc (product): 82009-052
Bupropion HCL ER (XL)	BUPROPION HCL ER (XL)	Direct_Rx	116cc898-66d6-e3a9-e063-6294a90a67fb	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090693 application number: ANDA090693
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	039d4368-c764-463a-b0cd-1cac702b8fb2	2026-02-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090693 application number: ANDA090693
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	6902b252-dc69-4b3c-bad2-b6667a5f6d84	2026-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090693 application number: ANDA090693
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Northwind Health Company, LLC	f2b30440-0e07-2670-e053-2995a90afa28	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090693 application number: ANDA090693
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	458c8a67-4995-c772-e063-6394a90a1f8d	2025-12-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090693 application number: ANDA090693
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	45789ff4-af5d-96b0-e063-6394a90a0644	2025-12-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090693 application number: ANDA090693
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	a0fdfc21-165a-43fa-9b3c-e48f3b892250	2025-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090693 application number: ANDA090693
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	eee88553-acff-4bdd-acd1-f39bcb6fcdca	2025-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090693 application number: ANDA090693
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	American Health Packaging	8dab6d17-bf41-4a28-90db-b66959c0e143	2025-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090693 application number: ANDA090693
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	AvPAK	2f9c5162-a6c5-e362-e063-6294a90a198d	2025-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090693 application number: ANDA090693
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	0e8b2109-8516-2d92-e063-6394a90a5d16	2025-01-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090693 application number: ANDA090693

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	56df4e22-81ca-48a4-a8e2-038448417355	6
993557	buPROPion HCl 300 MG 24HR Extended Release Oral Tablet	PSN	56df4e22-81ca-48a4-a8e2-038448417355	6
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	56df4e22-81ca-48a4-a8e2-038448417355	6
993557	24 HR bupropion hydrochloride 300 MG Extended Release Oral Tablet	SCD	56df4e22-81ca-48a4-a8e2-038448417355	6
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	56df4e22-81ca-48a4-a8e2-038448417355	6
993557	bupropion HCl XL 300 MG 24 HR Extended Release Oral Tablet	SY	56df4e22-81ca-48a4-a8e2-038448417355	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
82009-052-05	82009005205	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (82009-052-05)	2023-07-07	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bupropion Hydrochloride XL	Quallent Pharmaceuticals Health LLC \| LUPIN LIMITED	2026-04-24	HUMAN PRESCRIPTION DRUG LABEL	6