bupropion Hydrochloride

Product NDC: 69097-918
11-digit product format: 690970918
Labeler code: 69097
Product ID: 69097-918_c1d5cac6-7ca2-4b55-90c3-5ef51df0a1ee
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bupropion Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: CIPLA USA INC.,
Application: ANDA207389
Marketing category: ANDA
Marketing start: 2018-05-26
Substance: BUPROPION HYDROCHLORIDE
Active strength: 100 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207389-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL			2017-09-18
A207389-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL			2017-09-18

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 · 86 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	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2017-09-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2017-09-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2017-09-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2017-09-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2017-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2017-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2017-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2017-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2017-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2017-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2017-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2017-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2017-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2017-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2017-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2017-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2017-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2017-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2017-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2017-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2017-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2017-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2017-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2017-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2017-09-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2017-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2017-09-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2017-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2017-09-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2017-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2017-09-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2017-09-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-09-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-09-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-09-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-09-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-18	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207389-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207389-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207389-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207389-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207389-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207389-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207389-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207389-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207389-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207389-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207389-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207389-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207389-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207389-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207389-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207389-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207389-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207389-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207389-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207389-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207389-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207389-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207389-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207389-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207389-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207389-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207389-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207389-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207389-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A207389-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207389-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A207389-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207389-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207389-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207389-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207389-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207389-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207389-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207389-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207389-002	AB	1	`3f0d92c62455…`

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	100 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
993687	Internal RxNorm lookup
993691	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
e4100232-a25d-4468-9057-af7e66205154	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
69097-918-02	bupropion Hydrochloride	30 in 1 BOTTLE	TABLET	30	6
69097-918-07	bupropion Hydrochloride	100 in 1 BOTTLE	TABLET	100	6
69097-918-15	bupropion Hydrochloride	1000 in 1 BOTTLE	TABLET	1000	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69097-918-07	EA - Each	69097-918	e1527580-9628-4fc3-9949-3d4608af6c90	1	2018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69097-918	BUPROPION HYDROCHLORIDE TABLET [CIPLA USA INC.,]	6	Current NDC, Legacy NDC, 3 package rows	20230328_e4100232-a25d-4468-9057-af7e66205154.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 · 2 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	c1fa6fce-272b-4497-a958-177f0bafdfc7	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207389 application number: ANDA207389
bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	CIPLA USA INC.,	e4100232-a25d-4468-9057-af7e66205154	2023-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207389 application number: ANDA207389 ndc (product): 69097-918

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
993687	buPROPion HCl 100 MG Oral Tablet	PSN	c1fa6fce-272b-4497-a958-177f0bafdfc7	8
993687	bupropion hydrochloride 100 MG Oral Tablet	SCD	c1fa6fce-272b-4497-a958-177f0bafdfc7	8
993687	buPROPion HCl 100 MG Oral Tablet	PSN	e4100232-a25d-4468-9057-af7e66205154	6
993691	buPROPion HCl 75 MG Oral Tablet	PSN	e4100232-a25d-4468-9057-af7e66205154	6
993687	bupropion hydrochloride 100 MG Oral Tablet	SCD	e4100232-a25d-4468-9057-af7e66205154	6
993691	bupropion hydrochloride 75 MG Oral Tablet	SCD	e4100232-a25d-4468-9057-af7e66205154	6
993691	bupropion HCl 75 MG Oral Tablet	SY	e4100232-a25d-4468-9057-af7e66205154	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69097-918-02	69097091802	30 TABLET in 1 BOTTLE (69097-918-02)	30 tablet	2018-05-26	0000-00-00	No	No	Current
69097-918-07	69097091807	100 TABLET in 1 BOTTLE (69097-918-07)	100 tablet	2018-05-26	0000-00-00	No	No	Current
69097-918-15	69097091815	1000 TABLET in 1 BOTTLE (69097-918-15)	1000 tablet	2018-05-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
bupropion Hydrochloride	Bryant Ranch Prepack	2024-04-04	HUMAN PRESCRIPTION DRUG LABEL	8
bupropion Hydrochloride	CIPLA USA INC., \| InvaGen Pharmaceuticals Inc.	2023-03-27	HUMAN PRESCRIPTION DRUG LABEL	6
bupropion Hydrochloride	Preferred Pharmaceuticals Inc.	2021-03-30	HUMAN PRESCRIPTION DRUG LABEL	3
bupropion Hydrochloride	REMEDYREPACK INC.	2021-01-22	HUMAN PRESCRIPTION DRUG LABEL	2