Bupropion Hydrochloride

Product NDC: 64980-201
Requested package NDC: 64980-201-01
11-digit product format: 649800201
Labeler code: 64980
Product ID: 64980-201_74120afa-f695-48b1-9eef-36d58d56b906
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bupropion Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Rising Pharmaceuticals, Inc.
Application: ANDA203013
Marketing category: ANDA
Marketing start: 2018-06-18
Marketing end: 0000-00-00
Substance: BUPROPION HYDROCHLORIDE
Active strength: 75 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	64980-201	64980-201-01	D	Discontinued by firm		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 · 12 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…`

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
A203013-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2018-06-08
A203013-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2018-06-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203013-001	AB
A203013-002	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	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`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	A203013-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203013-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203013-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203013-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203013-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203013-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203013-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203013-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203013-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203013-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203013-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203013-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203013-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203013-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203013-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203013-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203013-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203013-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203013-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203013-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203013-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203013-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203013-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203013-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203013-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203013-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203013-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203013-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203013-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203013-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203013-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203013-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203013-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203013-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203013-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203013-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203013-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203013-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203013-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203013-002	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
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64980-201-01	EA - Each	64980-201	b7af96f7-19ac-497d-a8db-4ef5cedbc0d6	1	2018-11-06

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	990587bd-4c7d-4a36-8a38-3104648ab3a2	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203013 application number: ANDA203013
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	81d251aa-a8e8-493e-94ed-12f6fb8902e6	2025-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203013 application number: ANDA203013
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	b303a0ad-5971-44ab-937c-bcf3ff650358	2025-09-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203013 application number: ANDA203013
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ef0bb8f2-7710-4236-8b47-57b74c8bca3e	2024-01-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203013 application number: ANDA203013

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
993691	buPROPion HCl 75 MG Oral Tablet	PSN	6a300adb-b1c2-4250-bd15-272b04699edd	1
993691	bupropion hydrochloride 75 MG Oral Tablet	SCD	6a300adb-b1c2-4250-bd15-272b04699edd	1
993691	bupropion HCl 75 MG Oral Tablet	SY	6a300adb-b1c2-4250-bd15-272b04699edd	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
64980-201-01	64980020101	100 TABLET, FILM COATED in 1 BOTTLE (64980-201-01)	2018-06-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bupropion Hydrochloride	NuCare Pharmaceuticals,Inc.	2022-02-07	HUMAN PRESCRIPTION DRUG LABEL	2
Bupropion Hydrochloride	Bryant Ranch Prepack	2020-05-22	Human Prescription Drug Label	1
Bupropion Hydrochloride	Rising Pharmaceuticals, Inc. \| Alembic Pharmaceuticals Limited	2018-08-01	Human Prescription Drug Label	1