Bupropion Hydrochloride

Product NDC: 24689-120
Requested package NDC: 24689-120-01
11-digit product format: 246890120
Labeler code: 24689
Product ID: 24689-120_120b51f0-f2d3-1de1-e063-6294a90a3691
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bupropion Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Apnar Pharma LP
Application: ANDA075584
Marketing category: ANDA
Marketing start: 2021-12-20
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	24689-120	24689-120-01	D	Discontinued by firm		2026-08-03

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
A075584-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2000-02-07
A075584-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2000-02-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075584-001	AB
A075584-002	AB

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	A075584-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075584-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-02-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075584-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075584-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-02-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075584-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075584-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-02-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075584-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075584-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-02-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075584-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075584-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-02-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075584-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075584-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-02-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075584-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-02-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075584-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-02-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075584-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-02-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075584-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-02-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075584-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-02-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075584-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-02-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075584-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-02-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075584-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-02-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075584-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-02-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075584-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-02-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075584-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-02-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075584-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-02-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075584-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-02-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075584-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-02-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075584-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-02-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075584-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-02-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075584-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-02-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075584-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-02-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075584-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-02-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075584-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-02-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075584-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-02-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075584-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-02-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075584-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-02-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075584-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-02-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075584-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-02-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075584-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-02-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075584-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-02-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075584-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-02-07	`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	A075584-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075584-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075584-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075584-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075584-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075584-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075584-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075584-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075584-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075584-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075584-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075584-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075584-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075584-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075584-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075584-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075584-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075584-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075584-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075584-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075584-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075584-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075584-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075584-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075584-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075584-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075584-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075584-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075584-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075584-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075584-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075584-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075584-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075584-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075584-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075584-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075584-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075584-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075584-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075584-002	AB	1	`782e0a99824c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4eceb285-f3c7-4092-a21a-4c9f3169f20c	Product name	5	20260220
9e37788c-b1bf-42ae-aac9-b60601606144	Product name	8	20260122
1527ac37-808d-43be-a63e-74e1258dbe46	Product name	9	20250219
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
548ba7fd-fd0c-4a21-b2b0-d01bf93143b8	Product name	3	20240209
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
9fcb7a91-de07-4f00-aabf-e4d6fda403d5	Product name	8	20230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
b8ee525f-67fb-39fb-91da-7e47ac54581d	Product name	5	20200611
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
98e65af1-f5d0-75d5-c930-f8a4ce4c3284	Product name	9	20190211
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
7916de40-e296-41f0-b811-6d0df1a33e2c	Product name	9	20180627
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
e4d463bc-c674-43cb-be06-82786f310d01	Product name	1	20150326
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
0916dcfb-331f-89b1-8eac-6f7dc76d82da	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
d7fc3d53-5a6c-de82-2808-1780f175f17e	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
24689-120-01	Bupropion Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24689-120-01	EA - Each	24689-120	2edb25a8-d818-42f1-9d95-a5bb9b56729b	1	2022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24689-120	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [APNAR PHARMA LP]	6	Current NDC, Legacy NDC, 1 package rows	20240224_d1830cfd-e7f4-345c-e053-2995a90a2251.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Amici Pharma, Inc.	fbb587fa-75c0-4f4d-8eaf-f0e7ba8b5c75	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075584 application number: ANDA075584

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	d1830cfd-e7f4-345c-e053-2995a90a2251	6
993691	buPROPion HCl 75 MG Oral Tablet	PSN	d1830cfd-e7f4-345c-e053-2995a90a2251	6
993687	bupropion hydrochloride 100 MG Oral Tablet	SCD	d1830cfd-e7f4-345c-e053-2995a90a2251	6
993691	bupropion hydrochloride 75 MG Oral Tablet	SCD	d1830cfd-e7f4-345c-e053-2995a90a2251	6
993691	bupropion HCl 75 MG Oral Tablet	SY	d1830cfd-e7f4-345c-e053-2995a90a2251	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
24689-120-01	24689012001	100 TABLET, FILM COATED in 1 BOTTLE (24689-120-01)	2021-12-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bupropion Hydrochloride	Apnar Pharma LP \| InvaTech Pharma Solutions LLC \| Elysium Pharmaceuticals Ltd \| Apnar Pharma Private Limited \| APNAR PHARMA LLP	2024-02-23	HUMAN PRESCRIPTION DRUG LABEL	6