Bupropion Hydrochloride

Product NDC: 70436-010
11-digit product format: 704360010
Labeler code: 70436
Product ID: 70436-010_1b0d6505-54e6-a28f-e063-6294a90aae71
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bupropion hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Slate Run Pharmaceuticals, LLC
Application: ANDA210015
Marketing category: ANDA
Marketing start: 2018-12-01
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: 2026-12-31
Current FDA listing: Yes

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
A210015-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2018-06-14
A210015-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2018-06-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210015-001	AB3
A210015-002	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	A210015-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210015-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210015-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210015-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210015-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210015-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210015-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210015-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210015-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210015-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210015-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210015-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210015-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210015-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210015-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210015-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210015-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210015-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210015-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210015-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210015-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210015-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210015-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210015-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210015-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210015-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210015-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210015-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210015-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210015-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210015-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210015-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210015-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210015-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210015-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210015-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210015-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210015-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210015-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210015-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`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	A210015-001	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210015-002	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210015-001	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210015-002	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210015-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210015-002	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210015-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210015-002	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210015-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210015-002	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210015-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210015-002	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210015-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210015-002	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210015-001	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210015-002	AB3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210015-001	AB3	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210015-002	AB3	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210015-001	AB3	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210015-002	AB3	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210015-001	AB3	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210015-002	AB3	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210015-001	AB3	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210015-002	AB3	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210015-001	AB3	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210015-002	AB3	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210015-001	AB3	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210015-002	AB3	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210015-001	AB3	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210015-002	AB3	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210015-001	AB3	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210015-002	AB3	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210015-001	AB3	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210015-002	AB3	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210015-001	AB3	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210015-002	AB3	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210015-001	AB3	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210015-002	AB3	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210015-001	AB3	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210015-002	AB3	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Bupropion Hydrochloride
Brand name suffix: XL
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUPROPION HYDROCHLORIDE	150 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
993541	Internal RxNorm lookup
993557	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
06d4d890-11ed-4f31-8778-c73432e3ea69	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
98e65af1-f5d0-75d5-c930-f8a4ce4c3284	Product name	9	20190211
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
e4d463bc-c674-43cb-be06-82786f310d01	Product name	1	20150326
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
0916dcfb-331f-89b1-8eac-6f7dc76d82da	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	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
70436-010-02	Bupropion HydrochlorideXL	500 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	500	14
70436-010-04	Bupropion HydrochlorideXL	30 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	30	14
70436-010-06	Bupropion HydrochlorideXL	90 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	90	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70436-010-02	EA - Each	70436-010	a40cbe8c-d89c-4b50-b1af-b2f31d0e8075	1	2019-01-24
70436-010-04	EA - Each	70436-010	2d42eb4b-7b63-4b65-9404-c4b2e2d2959a	1	2019-01-24
70436-010-06	EA - Each	70436-010	1313d030-08bb-47c9-b487-f897a15c49b9	1	2019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70436-010	BUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [SLATE RUN PHARMACEUTICALS, LLC]	14	Current NDC, Legacy NDC, 3 package rows	20240617_06d4d890-11ed-4f31-8778-c73432e3ea69.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	eb946d81-b4f4-42e9-aa7a-31d76d15629c	2026-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210015 application number: ANDA210015
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	9aa3753f-1a0e-4faa-995f-67e29b320737	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210015 application number: ANDA210015
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	b2e6c30f-a33c-4854-ab19-bc9f65880374	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210015 application number: ANDA210015
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	02275c51-6b3e-434a-bdb5-99135e73f1a4	2026-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210015 application number: ANDA210015
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	eb25adb1-9841-42ce-aa22-718fb0fba5dd	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210015 application number: ANDA210015
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Epic Pharma, LLC	f79d1422-a9b6-41c2-a46d-22886605f94d	2026-02-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210015 application number: ANDA210015
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Slate Run Pharmaceuticals, LLC	06d4d890-11ed-4f31-8778-c73432e3ea69	2024-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210015 application number: ANDA210015 ndc (product): 70436-010
Bupropion HCL ER (XL)	BUPROPION HCL ER (XL)	Direct_RX	129ce80c-0333-873e-e063-6394a90a33e0	2024-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210015 application number: ANDA210015
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	NuCare Pharmacueticals, Inc.	15ad0c66-1829-59c3-e063-6394a90a4384	2024-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210015 application number: ANDA210015
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Proficient Rx LP	dfd5f264-d4fd-4441-88b1-48086c7c0616	2024-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210015 application number: ANDA210015
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Proficient Rx LP	4a2be6af-e256-4fa9-bfa9-5300d52cdaf4	2020-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210015 application number: ANDA210015

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
993541	buPROPion HCl 150 MG 24HR Extended Release Oral Tablet	PSN	06d4d890-11ed-4f31-8778-c73432e3ea69	14
993557	buPROPion HCl 300 MG 24HR Extended Release Oral Tablet	PSN	06d4d890-11ed-4f31-8778-c73432e3ea69	14
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	06d4d890-11ed-4f31-8778-c73432e3ea69	14
993557	24 HR bupropion hydrochloride 300 MG Extended Release Oral Tablet	SCD	06d4d890-11ed-4f31-8778-c73432e3ea69	14
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	06d4d890-11ed-4f31-8778-c73432e3ea69	14
993557	bupropion HCl XL 300 MG 24 HR Extended Release Oral Tablet	SY	06d4d890-11ed-4f31-8778-c73432e3ea69	14
993541	buPROPion HCl 150 MG 24HR Extended Release Oral Tablet	PSN	4a2be6af-e256-4fa9-bfa9-5300d52cdaf4	1
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	4a2be6af-e256-4fa9-bfa9-5300d52cdaf4	1
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	4a2be6af-e256-4fa9-bfa9-5300d52cdaf4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70436-010-02	70436001002	500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-010-02)	2018-12-01	0000-00-00	No	No	Current
70436-010-04	70436001004	30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-010-04)	2018-12-01	0000-00-00	No	No	Current
70436-010-06	70436001006	90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-010-06)	2018-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bupropion Hydrochloride XL	Major Pharmaceuticals	2025-03-11	HUMAN PRESCRIPTION DRUG LABEL	5
Bupropion Hydrochloride XL	Slate Run Pharmaceuticals, LLC \| Yichang Humanwell Pharmaceutical Co., Ltd. \| Yichang Humanwell Oral Solid Dosage Plant	2024-06-16	HUMAN PRESCRIPTION DRUG LABEL	14
Bupropion Hydrochloride XL	NCS HealthCare of KY, LLC dba Vangard Labs \| Yichang Humanwell Oral Solid Dosage Plant	2024-01-18	HUMAN PRESCRIPTION DRUG LABEL	3
Bupropion Hydrochloride XL	REMEDYREPACK INC.	2022-05-03	HUMAN PRESCRIPTION DRUG LABEL	8
Bupropion Hydrochloride XL	Proficient Rx LP	2020-02-01	HUMAN PRESCRIPTION DRUG LABEL	1