Bupropion Hydrochloride

Product NDC: 0615-8504
11-digit product format: 006158504
Labeler code: 0615
Product ID: 0615-8504_31890576-e68d-4449-b0dd-205175720f6b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bupropion Hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: NCS HealthCare of KY, LLC dba Vangard Labs
Application: ANDA211020
Marketing category: ANDA
Marketing start: 2022-08-01
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211020-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2019-01-28
A211020-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2019-01-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211020-001	AB3
A211020-002	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	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`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	A211020-001	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211020-002	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211020-001	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211020-002	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211020-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211020-002	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211020-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211020-002	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211020-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211020-002	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211020-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211020-002	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211020-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211020-002	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211020-001	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211020-002	AB3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211020-001	AB3	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211020-002	AB3	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211020-001	AB3	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211020-002	AB3	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211020-001	AB3	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211020-002	AB3	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211020-001	AB3	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211020-002	AB3	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211020-001	AB3	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211020-002	AB3	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211020-001	AB3	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211020-002	AB3	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211020-001	AB3	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211020-002	AB3	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211020-001	AB3	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211020-002	AB3	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211020-001	AB3	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211020-002	AB3	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211020-001	AB3	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211020-002	AB3	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211020-001	AB3	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211020-002	AB3	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211020-001	AB3	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211020-002	AB3	1	`782e0a99824c…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	a613cfd3-1aa1-49c5-b742-b105c97d73f1	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211020 application number: ANDA211020
bupropion hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	136f29fa-a859-4efb-8365-1382716d6f8f	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211020 application number: ANDA211020
bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Rising Pharma Holdings, Inc.	e4f4d3fa-ddf6-4125-8486-8157efc095c1	2026-03-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211020 application number: ANDA211020
bupropion hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	d087222e-c5e9-4c48-b27f-e2e2944379c8	2025-08-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211020 application number: ANDA211020
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	aeb506f8-97c2-409a-aac9-5a73c840e8f3	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211020 application number: ANDA211020 ndc (product): 0615-8504

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
aeb506f8-97c2-409a-aac9-5a73c840e8f3	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	Strength	SPL version
0615-8504-05	Bupropion Hydrochloride	15 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	15		2
0615-8504-39	Bupropion Hydrochloride	30 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0615-8504	BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]	2	Current NDC, 2 package rows	20240814_aeb506f8-97c2-409a-aac9-5a73c840e8f3.zip

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	aeb506f8-97c2-409a-aac9-5a73c840e8f3	2
993557	buPROPion HCl 300 MG 24HR Extended Release Oral Tablet	PSN	aeb506f8-97c2-409a-aac9-5a73c840e8f3	2
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	aeb506f8-97c2-409a-aac9-5a73c840e8f3	2
993557	24 HR bupropion hydrochloride 300 MG Extended Release Oral Tablet	SCD	aeb506f8-97c2-409a-aac9-5a73c840e8f3	2
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	aeb506f8-97c2-409a-aac9-5a73c840e8f3	2
993557	bupropion HCl XL 300 MG 24 HR Extended Release Oral Tablet	SY	aeb506f8-97c2-409a-aac9-5a73c840e8f3	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
0615-8504-05	00615850405	15 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8504-05)	2024-07-16	No	No	Current
0615-8504-39	00615850439	30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8504-39)	2024-03-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bupropion Hydrochloride	NCS HealthCare of KY, LLC dba Vangard Labs	2024-08-12	HUMAN PRESCRIPTION DRUG LABEL	2