Bupropion

Product NDC: 67046-699
Requested package NDC: 67046-699-30
11-digit product format: 670460699
Labeler code: 67046
Product ID: 67046-699_65067909-4e70-63b5-e053-2991aa0ae8a9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bupropion
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Coupler Enterprises Inc
Application: ANDA090693
Marketing category: ANDA
Marketing start: 2017-02-14
Marketing end: 0000-00-00
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: 2020-12-31
Current FDA listing: Historical FDA.report record

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	67046-699	67046-699-30	I	Inactivated by FDA		2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

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
A090693-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2017-04-06
A090693-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2017-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090693-001	AB3
A090693-002	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	A090693-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090693-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090693-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090693-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090693-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090693-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090693-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090693-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090693-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090693-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090693-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090693-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090693-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090693-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090693-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090693-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090693-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090693-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090693-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090693-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090693-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090693-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090693-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090693-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090693-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090693-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090693-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090693-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090693-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090693-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090693-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090693-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090693-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090693-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090693-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090693-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090693-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090693-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090693-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090693-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-06	`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	A090693-001	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090693-002	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090693-001	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090693-002	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090693-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090693-002	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090693-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090693-002	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090693-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090693-002	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090693-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090693-002	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090693-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090693-002	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090693-001	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090693-002	AB3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090693-001	AB3	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090693-002	AB3	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090693-001	AB3	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090693-002	AB3	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090693-001	AB3	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090693-002	AB3	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090693-001	AB3	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090693-002	AB3	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090693-001	AB3	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090693-002	AB3	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090693-001	AB3	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090693-002	AB3	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090693-001	AB3	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090693-002	AB3	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090693-001	AB3	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090693-002	AB3	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090693-001	AB3	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090693-002	AB3	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090693-001	AB3	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090693-002	AB3	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090693-001	AB3	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090693-002	AB3	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090693-001	AB3	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090693-002	AB3	1	`782e0a99824c…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67046-699-30	2022-01-28	C162847	48780-1	d6a99b39-e9f2-a426-e053-dadaa90af4c2	699 Bupropion XL 150MG

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67046-699-30	BupropionXL	30 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67046-699	BUPROPION XL (BUPROPION) TABLET, EXTENDED RELEASE [COUPLER ENTERPRISES INC]	1	Legacy NDC, 1 package rows	20180212_650659e9-e160-1d04-e053-2a91aa0ae49a.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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Major Pharmaceuticals	aa3d3e5b-74a3-47f6-b9aa-d6e248e950e5	2026-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090693 application number: ANDA090693
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	740534d3-59b5-4938-8e38-16275a14438c	2026-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090693 application number: ANDA090693
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	1af14d2e-c64d-44b7-a402-8869e8e30661	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090693 application number: ANDA090693
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Coupler LLC	512b0ed3-db7d-b273-e063-6394a90a25cc	2026-05-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090693 application number: ANDA090693
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	bcbef1b4-a135-4231-bc65-7d0b335260e8	2026-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090693 application number: ANDA090693
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Quallent Pharmaceuticals Health LLC	56df4e22-81ca-48a4-a8e2-038448417355	2026-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090693 application number: ANDA090693
Bupropion HCL ER (XL)	BUPROPION HCL ER (XL)	Direct_Rx	116cc898-66d6-e3a9-e063-6294a90a67fb	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090693 application number: ANDA090693
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	039d4368-c764-463a-b0cd-1cac702b8fb2	2026-02-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090693 application number: ANDA090693
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	6902b252-dc69-4b3c-bad2-b6667a5f6d84	2026-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090693 application number: ANDA090693
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Northwind Health Company, LLC	f2b30440-0e07-2670-e053-2995a90afa28	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090693 application number: ANDA090693
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	458c8a67-4995-c772-e063-6394a90a1f8d	2025-12-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090693 application number: ANDA090693
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	45789ff4-af5d-96b0-e063-6394a90a0644	2025-12-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090693 application number: ANDA090693
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	a0fdfc21-165a-43fa-9b3c-e48f3b892250	2025-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090693 application number: ANDA090693
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	eee88553-acff-4bdd-acd1-f39bcb6fcdca	2025-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090693 application number: ANDA090693
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	American Health Packaging	8dab6d17-bf41-4a28-90db-b66959c0e143	2025-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090693 application number: ANDA090693
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	AvPAK	2f9c5162-a6c5-e362-e063-6294a90a198d	2025-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090693 application number: ANDA090693
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	0e8b2109-8516-2d92-e063-6394a90a5d16	2025-01-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090693 application number: ANDA090693

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
ZG7E5POY8O	BUPROPION HYDROCHLORIDE	31677-93-7	BUPROPION HYDROCHLORIDE
01ZG3TPX31	BUPROPION	34911-55-2	Bupropion

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	650659e9-e160-1d04-e053-2a91aa0ae49a	1
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	650659e9-e160-1d04-e053-2a91aa0ae49a	1
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	650659e9-e160-1d04-e053-2a91aa0ae49a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
67046-699-30	67046069930	30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-699-30)	2017-02-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
699 Bupropion XL 150MG	Coupler Enterprises Inc \| Coupler Enterprises Inc.	2017-02-14	HUMAN PRESCRIPTION DRUG LABEL	1