Bupropion hydrochloride

Product NDC: 70010-784
11-digit product format: 700100784
Labeler code: 70010
Product ID: 70010-784_4dc0e5b6-865c-6e62-e063-6394a90a6231
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bupropion hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Granules Pharmaceuticals Inc.
Application: ANDA215568
Marketing category: ANDA
Marketing start: 2022-12-15
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: 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
A215568-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2022-02-02
A215568-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2022-02-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215568-001	AB3
A215568-002	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 2 · 64 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	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`1c564ffb4f44…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 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	A215568-001	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215568-002	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215568-001	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215568-002	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215568-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215568-002	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215568-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215568-002	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215568-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215568-002	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215568-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215568-002	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215568-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215568-002	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215568-001	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215568-002	AB3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215568-001	AB3	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215568-002	AB3	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215568-001	AB3	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215568-002	AB3	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215568-001	AB3	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215568-002	AB3	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215568-001	AB3	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215568-002	AB3	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215568-001	AB3	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215568-002	AB3	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215568-001	AB3	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215568-002	AB3	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215568-001	AB3	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215568-002	AB3	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215568-001	AB3	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A215568-002	AB3	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215568-001	AB3	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A215568-002	AB3	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215568-001	AB3	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A215568-002	AB3	1	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215568-001	AB3	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215568-002	AB3	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215568-001	AB3	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215568-002	AB3	1	`1c564ffb4f44…`

Additional Listing Data#

Finished product: Yes
Brand name base: Bupropion hydrochloride
Listing expiration: 2027-12-31

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
d9eb0939-63c1-48c4-a444-a899d7924d06	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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
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
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
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
70010-784-03	Bupropion hydrochloride	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	10
70010-784-05	Bupropion hydrochloride	500 in 1 BOTTLE	TABLET, EXTENDED RELEASE	500	10
70010-784-09	Bupropion hydrochloride	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70010-784-03	EA - Each	70010-784	12792880-78cd-48ab-956d-de4de947a52d	1	2024-05-16
70010-784-05	EA - Each	70010-784	5acd8faa-a5c6-44e1-9b9c-468dad5231a7	1	2024-05-16
70010-784-09	EA - Each	70010-784	bc084c20-bbd5-4839-84af-f0447d786dc3	1	2024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70010-784	BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [GRANULES PHARMACEUTICALS INC.]	8	Current NDC, Legacy NDC, 3 package rows	20240704_d9eb0939-63c1-48c4-a444-a899d7924d06.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	c60855ca-4fa0-4004-ad19-4abb61100c43	2026-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215568 application number: ANDA215568
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	bf5e933c-8a84-4dd7-a05d-6c4a82b6c965	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215568 application number: ANDA215568
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	af5b1cc8-f078-4a7b-b64a-4cb2de1e5721	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215568 application number: ANDA215568
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Unit Dose Solutions, Inc.	53c192ca-ac51-cb87-e063-6394a90a6c08	2026-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215568 application number: ANDA215568
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Proficient Rx LP	f1703bfd-be36-4fde-8e67-df0fb5d93369	2026-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215568 application number: ANDA215568
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Granules Pharmaceuticals Inc.	d9eb0939-63c1-48c4-a444-a899d7924d06	2026-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215568 application number: ANDA215568 ndc (product): 70010-784
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	BluePoint Laboratories	4956af38-182a-4015-a945-67e40bd38772	2026-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215568 application number: ANDA215568
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Coupler LLC	487271f1-c956-086a-e063-6394a90a2dc7	2026-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215568 application number: ANDA215568
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	069e6828-e599-4614-9645-9cf1382ac93e	2025-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215568 application number: ANDA215568
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	82872e51-3349-40fe-8ea3-496751955fed	2025-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215568 application number: ANDA215568
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	e47df78d-5e9b-485d-8d92-0e00602f7a31	2025-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215568 application number: ANDA215568
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Coupler LLC	2ccbf988-64b6-3a60-e063-6394a90ababa	2025-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215568 application number: ANDA215568
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	1724f474-d6ab-46af-940f-7f874d4ff7fc	2025-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215568 application number: ANDA215568

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	af5b1cc8-f078-4a7b-b64a-4cb2de1e5721	100
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	af5b1cc8-f078-4a7b-b64a-4cb2de1e5721	100
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	af5b1cc8-f078-4a7b-b64a-4cb2de1e5721	100
993541	buPROPion HCl 150 MG 24HR Extended Release Oral Tablet	PSN	d9eb0939-63c1-48c4-a444-a899d7924d06	10
993557	buPROPion HCl 300 MG 24HR Extended Release Oral Tablet	PSN	d9eb0939-63c1-48c4-a444-a899d7924d06	10
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	d9eb0939-63c1-48c4-a444-a899d7924d06	10
993557	24 HR bupropion hydrochloride 300 MG Extended Release Oral Tablet	SCD	d9eb0939-63c1-48c4-a444-a899d7924d06	10
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	d9eb0939-63c1-48c4-a444-a899d7924d06	10
993557	bupropion HCl XL 300 MG 24 HR Extended Release Oral Tablet	SY	d9eb0939-63c1-48c4-a444-a899d7924d06	10
993541	buPROPion HCl 150 MG 24HR Extended Release Oral Tablet	PSN	c60855ca-4fa0-4004-ad19-4abb61100c43	2
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	c60855ca-4fa0-4004-ad19-4abb61100c43	2
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	c60855ca-4fa0-4004-ad19-4abb61100c43	2
993541	buPROPion HCl 150 MG 24HR Extended Release Oral Tablet	PSN	069e6828-e599-4614-9645-9cf1382ac93e	1
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	069e6828-e599-4614-9645-9cf1382ac93e	1
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	069e6828-e599-4614-9645-9cf1382ac93e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70010-784-03	70010078403	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-784-03)	2022-12-15	0000-00-00	No	No	Current
70010-784-05	70010078405	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-784-05)	2022-12-15	0000-00-00	No	No	Current
70010-784-09	70010078409	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-784-09)	2022-12-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bupropion hydrochloride	REMEDYREPACK INC.	2026-07-22	HUMAN PRESCRIPTION DRUG LABEL	3
Bupropion hydrochloride	Bryant Ranch Prepack	2026-06-11	HUMAN PRESCRIPTION DRUG LABEL	101
Bupropion hydrochloride	Proficient Rx LP	2026-06-01	HUMAN PRESCRIPTION DRUG LABEL	1
Bupropion hydrochloride	Granules Pharmaceuticals Inc.	2026-03-24	HUMAN PRESCRIPTION DRUG LABEL	10
Bupropion hydrochloride	Preferred Pharmaceuticals Inc.	2025-09-04	HUMAN PRESCRIPTION DRUG LABEL	1