Bupropion Hydrochloride

Product NDC: 70934-791
Requested package NDC: 70934-791-60
11-digit product format: 709340791
Labeler code: 70934
Product ID: 70934-791_c1233155-199f-b573-e053-2a95a90a4617
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bupropion hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Denton Pharma, Inc. dba Northwind Pharmaceuticals
Application: ANDA205794
Marketing category: ANDA
Marketing start: 2020-09-08
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: 2022-12-31
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	70934-791	70934-791-60	I	Inactivated by FDA		2026-08-03

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 · 15 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…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A205794-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01
A205794-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01
A205794-003	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A205794-001	AB1
A205794-002	AB1
A205794-003	AB1

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 4 · 123 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	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A205794-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205794-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205794-003	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205794-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205794-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205794-003	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205794-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205794-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205794-003	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205794-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205794-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205794-003	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205794-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205794-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205794-003	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205794-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205794-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205794-003	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205794-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205794-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205794-003	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205794-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205794-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205794-003	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205794-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205794-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205794-003	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205794-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205794-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205794-003	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205794-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205794-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205794-003	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205794-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205794-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205794-003	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205794-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205794-002	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205794-003	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205794-001	AB1	1	`8072bd15b7f6…`

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
2e254488-9fcb-41b3-a7c3-e2c9a3941b29	Product name	1	20200603
b4ff0805-126a-406d-9cae-fc34fd8e8889	Product name	1	20190711
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, Related label table
NDC	Related label
70934-791-30	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR). BUPROPION HYDROCHLORIDE extended-release tablets (SR), for oral use Initial U.S. Approval: 1985
70934-791-60	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR). BUPROPION HYDROCHLORIDE extended-release tablets (SR), for oral use Initial U.S. Approval: 1985
70934-791-90	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR). BUPROPION HYDROCHLORIDE extended-release tablets (SR), for oral use Initial U.S. Approval: 1985
70934-791-96	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR). BUPROPION HYDROCHLORIDE extended-release tablets (SR), for oral use Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70934-791-30	Bupropion HydrochlorideSR	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	30	3
70934-791-60	Bupropion HydrochlorideSR	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	60	3
70934-791-90	Bupropion HydrochlorideSR	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	90	3
70934-791-96	Bupropion HydrochlorideSR	180 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	180	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70934-791-30	EA - Each	70934-791	14076eb4-54b3-459d-85f5-22823636246b	1	2022-11-07
70934-791-60	EA - Each	70934-791	73d09000-0581-499c-a546-1a69add79393	1	2022-11-07
70934-791-90	EA - Each	70934-791	3305b356-a95d-424d-b6f2-cad6ce305b35	1	2022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70934-791	BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]	3	Legacy NDC, 4 package rows	20210512_b1169882-c785-62ab-e053-2995a90ae641.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 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	c76f2f9f-3999-4bdd-8ec3-e0066318d378	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Northwind Health Company, LLC	0865f8cf-1d7f-0e67-e063-6294a90a2f4d	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	6701af43-bf7d-45c4-a331-a18d16bd68f7	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	21be6b3b-add3-43e7-af93-30350aefc89e	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	a72db723-df4b-4bf4-9bdc-05ae82058696	2026-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	c37bb183-f272-4cae-96e1-7042c1dd7bcf	2026-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	fd153957-ff74-4134-8545-cdc0e5619906	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	c0445fea-108f-4e00-a2ae-ebbdf2719947	2026-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	d1d1ed19-e111-4652-a0d4-9406e6f73e9f	2026-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	0b33fb1f-a7f0-4ab7-a882-eca2d2c77afa	2026-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	b47c5515-a438-40bc-b8ad-26a6cf9676b7	2026-03-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	4bd469b8-fb35-0223-e063-6294a90ae7bc	2026-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	9d0608a1-0cc8-491a-ad91-238e0ea009fe	2026-02-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Dr. Reddys Laboratories Inc.	ad784c8e-7201-4336-a310-616e3e979ca4	2026-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	ScieGen Pharmaceuticals, Inc.	092da413-ec60-4577-ac57-51e3e42d55c9	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Radha Pharmaceuticals, Inc.	161637d2-bc9d-4a2b-ad1f-6cc39ffd69ce	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	eeb3fed1-2202-09fc-e053-2995a90a9f63	2025-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Proficient Rx LP	1094ff8e-f5a5-4a72-8bf9-25e68f5c964a	2025-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
BUPROPION HYDROCHLORIDE SR	BUPROPION HYDROCHLORIDE SR	DirectRx	dd4041cd-00e4-d10f-e053-2a95a90a5945	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	339c7157-1c65-40d1-bbcc-c10348d908d3	2024-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794

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
993518	buPROPion HCl 150 MG 12HR Extended Release Oral Tablet	PSN	b1169882-c785-62ab-e053-2995a90ae641	3
993518	12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	b1169882-c785-62ab-e053-2995a90ae641	3
993518	bupropion HCl 150 MG 12 HR Extended Release Oral Tablet	SY	b1169882-c785-62ab-e053-2995a90ae641	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70934-791-60	70934079160	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70934-791-60)	2020-09-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bupropion Hydrochloride SR	Denton Pharma, Inc. dba Northwind Pharmaceuticals	2021-04-29	HUMAN PRESCRIPTION DRUG LABEL	3