Bupropion hydrochloride

Product NDC: 50090-7422
Requested package NDC: 50090-7422-1
11-digit product format: 500907422
Labeler code: 50090
Product ID: 50090-7422_09fd6ebb-17e7-4c6f-998d-289eefc5ba27
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bupropion hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA216800
Marketing category: ANDA
Marketing start: 2023-05-31
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 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A216800-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31
A216800-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31
A216800-003	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A216800-001	AB1
A216800-002	AB1
A216800-003	AB1

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 · 72 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
2026-09-14 22:38:34	2026-08	A216800-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216800-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216800-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216800-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216800-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216800-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216800-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216800-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216800-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216800-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216800-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216800-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216800-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216800-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216800-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216800-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216800-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216800-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216800-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216800-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216800-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216800-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216800-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216800-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216800-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216800-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216800-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216800-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216800-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216800-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216800-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216800-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216800-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216800-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216800-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216800-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216800-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216800-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216800-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216800-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2023-05-31	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A216800-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216800-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216800-003	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216800-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216800-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216800-003	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216800-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216800-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216800-003	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216800-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216800-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216800-003	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216800-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216800-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216800-003	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216800-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216800-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216800-003	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216800-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216800-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216800-003	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216800-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216800-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216800-003	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216800-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216800-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216800-003	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216800-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216800-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216800-003	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216800-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216800-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216800-003	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216800-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216800-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216800-003	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216800-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216800-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216800-003	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216800-001	AB1	1	`301d65b070ca…`

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 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
993518	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
bb63261f-ad18-4885-9ed7-e7dfde33e171	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	SPL version
50090-7422-0	Bupropion hydrochloride	60 in 1 BOTTLE	TABLET, EXTENDED RELEASE	60	1
50090-7422-1	Bupropion hydrochloride	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	1
50090-7422-2	Bupropion hydrochloride	180 in 1 BOTTLE	TABLET, EXTENDED RELEASE	180	1
50090-7422-3	Bupropion hydrochloride	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-7422-0	EA - Each	50090-7422	3c592f44-6bf3-49ba-b8ad-bfbf2543cd07	1	2024-12-10
50090-7422-1	EA - Each	50090-7422	3ead00e1-311e-4932-b0da-70b292cc2715	1	2024-12-10
50090-7422-2	EA - Each	50090-7422	1dcb2768-5830-49a0-b766-0895dd769b03	1	2024-12-10
50090-7422-3	EA - Each	50090-7422	cfd2788c-f729-4df3-8af8-662c92e96ed6	1	2024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-7422	BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]	1	Current NDC, 4 package rows	20241102_bb63261f-ad18-4885-9ed7-e7dfde33e171.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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupropion HCL ER(SR)	BUPROPION HCL ER(SR)	DriectRx	50afb442-e7c6-d28c-e063-6294a90a2b7e	2026-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216800 application number: ANDA216800
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	6087100f-3ba4-412e-b08d-768d1dcdaf00	2026-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216800 application number: ANDA216800
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	0aa86bd6-b37b-45f7-a837-b067e41184e9	2026-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216800 application number: ANDA216800
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Coupler LLC	5604eb14-bab4-4f06-e063-6294a90a6920	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216800 application number: ANDA216800
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	350336bf-57b1-4d2f-bf25-956bb6023c07	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216800 application number: ANDA216800
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	5c111cf0-0199-4a4d-8138-81579af4c14d	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216800 application number: ANDA216800
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	4c9a5dc3-bebe-431a-b550-ce46c6c6b01e	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216800 application number: ANDA216800
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	30c5b97c-b19d-4d27-bb1a-ab19b7dfccaa	2026-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216800 application number: ANDA216800
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	f69b322b-93ab-407a-bf25-fe13c6896ca6	2026-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216800 application number: ANDA216800
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	093c4a61-02d9-4b55-b612-569aa25d3f2a	2026-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216800 application number: ANDA216800
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	1bd2ed35-35c5-464f-bf51-9dd4b42ee59a	2025-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216800 application number: ANDA216800
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Coupler LLC	38f52cec-9534-dab8-e063-6294a90a0704	2025-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216800 application number: ANDA216800
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	c5d55b0c-8b81-476a-994e-1989e2a56255	2025-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216800 application number: ANDA216800
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	bb63261f-ad18-4885-9ed7-e7dfde33e171	2024-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216800 application number: ANDA216800 ndc (package): 50090-7422-1 ndc (product): 50090-7422 ndc11 (package): 50090742201
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	a724b3b6-f60e-4b88-8603-8141a32075da	2024-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216800 application number: ANDA216800

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
993518	buPROPion HCl 150 MG 12HR Extended Release Oral Tablet	PSN	bb63261f-ad18-4885-9ed7-e7dfde33e171	1
993518	12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	bb63261f-ad18-4885-9ed7-e7dfde33e171	1
993518	bupropion HCl 150 MG 12 HR Extended Release Oral Tablet	SY	bb63261f-ad18-4885-9ed7-e7dfde33e171	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
50090-7422-1	50090742201	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-7422-1)	2024-10-28	No	No	Current