BUPROPION HYDROCHLORIDE

Product NDC: 16729-443
11-digit product format: 167290443
Labeler code: 16729
Product ID: 16729-443_4092a3ea-403d-7a91-e063-6394a90a8ddf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BUPROPION HYDROCHLORIDE
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Accord Healthcare Inc.
Application: ANDA210497
Marketing category: ANDA
Marketing start: 2018-11-08
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
A210497-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2018-10-31
A210497-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2018-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210497-001	AB3
A210497-002	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	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`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	A210497-001	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210497-002	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210497-001	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210497-002	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210497-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210497-002	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210497-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210497-002	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210497-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210497-002	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210497-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210497-002	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210497-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210497-002	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210497-001	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210497-002	AB3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210497-001	AB3	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210497-002	AB3	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210497-001	AB3	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210497-002	AB3	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210497-001	AB3	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210497-002	AB3	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210497-001	AB3	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210497-002	AB3	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210497-001	AB3	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210497-002	AB3	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210497-001	AB3	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210497-002	AB3	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210497-001	AB3	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210497-002	AB3	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210497-001	AB3	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210497-002	AB3	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210497-001	AB3	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210497-002	AB3	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210497-001	AB3	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210497-002	AB3	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210497-001	AB3	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210497-002	AB3	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210497-001	AB3	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210497-002	AB3	1	`782e0a99824c…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	080853c0-fcab-4645-9ddc-4946e895ac5f	2026-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	82bcdd72-9146-4c8d-a8aa-f92015864605	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	42e228a2-25b3-44a6-8da7-6616ca44ac7f	2026-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ae3bcdf7-d7f3-4f07-8113-af08af20a0d4	2026-02-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Accord Healthcare Inc.	34686e9d-c106-4276-8b47-7460cca8860e	2025-10-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497 ndc (product): 16729-443
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	5dec4414-5595-46c9-ada9-3fbe98152040	2025-02-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	DIRECT RX	96d87edc-d12b-44b2-e053-2995a90a4e63	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	f8af7829-8b61-6785-e053-6294a90af052	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	29a6c6e3-f30f-6541-e063-6394a90ae11d	2024-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Quality Care Products, LLC	a225dbbb-86f0-4547-a1c8-68eb64cd6892	2024-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	BluePoint Laboratories	5ccec958-998d-43a1-86fb-eb2b5e697b77	2024-11-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	7c46d95a-26f6-4364-8197-9e564e3405f2	2024-08-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	a18b5460-fcbb-42dd-8b87-197d11a08928	2024-05-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	77b78d35-40f5-4713-8468-aa09a6c2925d	2024-05-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Proficient Rx LP	5d40e301-7e06-4ecd-b7c6-3d7ac6a134d2	2022-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Proficient Rx LP	42201f4a-8856-4499-8bc3-d18612b1ec34	2022-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497

Additional Listing Data#

Finished product: Yes
Brand name base: BUPROPION HYDROCHLORIDE
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
34686e9d-c106-4276-8b47-7460cca8860e	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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
16729-443-10	BUPROPION HYDROCHLORIDE	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	13
16729-443-15	BUPROPION HYDROCHLORIDE	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90	13
16729-443-16	BUPROPION HYDROCHLORIDE	500 in 1 BOTTLE	TABLET, EXTENDED RELEASE	500	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16729-443-10	EA - Each	16729-443	a559fd11-0424-47db-bdaf-54cf5c5a7755	1	2018-12-13
16729-443-15	EA - Each	16729-443	873ab4be-00e5-4ebc-bac3-6cb53df7271c	1	2018-12-13
16729-443-16	EA - Each	16729-443	27998e18-e690-4de4-84cf-2033787e96f8	1	2018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16729-443	BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACCORD HEALTHCARE INC.]	12	Current NDC, Legacy NDC, 3 package rows	20241127_34686e9d-c106-4276-8b47-7460cca8860e.zip

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	080853c0-fcab-4645-9ddc-4946e895ac5f	22
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	080853c0-fcab-4645-9ddc-4946e895ac5f	22
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	080853c0-fcab-4645-9ddc-4946e895ac5f	22
993503	buPROPion HCl 100 MG 12HR Extended Release Oral Tablet	PSN	96d87edc-d12b-44b2-e053-2995a90a4e63	18
993541	buPROPion HCl 150 MG 24HR Extended Release Oral Tablet	PSN	96d87edc-d12b-44b2-e053-2995a90a4e63	18
993557	buPROPion HCl 300 MG 24HR Extended Release Oral Tablet	PSN	96d87edc-d12b-44b2-e053-2995a90a4e63	18
993503	12 HR bupropion hydrochloride 100 MG Extended Release Oral Tablet	SCD	96d87edc-d12b-44b2-e053-2995a90a4e63	18
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	96d87edc-d12b-44b2-e053-2995a90a4e63	18
993557	24 HR bupropion hydrochloride 300 MG Extended Release Oral Tablet	SCD	96d87edc-d12b-44b2-e053-2995a90a4e63	18
993503	bupropion HCl 100 MG 12 HR Extended Release Oral Tablet	SY	96d87edc-d12b-44b2-e053-2995a90a4e63	18
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	96d87edc-d12b-44b2-e053-2995a90a4e63	18
993557	bupropion HCl XL 300 MG 24 HR Extended Release Oral Tablet	SY	96d87edc-d12b-44b2-e053-2995a90a4e63	18
993541	buPROPion HCl 150 MG 24HR Extended Release Oral Tablet	PSN	ae3bcdf7-d7f3-4f07-8113-af08af20a0d4	15
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	ae3bcdf7-d7f3-4f07-8113-af08af20a0d4	15
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	ae3bcdf7-d7f3-4f07-8113-af08af20a0d4	15
993541	buPROPion HCl 150 MG 24HR Extended Release Oral Tablet	PSN	34686e9d-c106-4276-8b47-7460cca8860e	13
993557	buPROPion HCl 300 MG 24HR Extended Release Oral Tablet	PSN	34686e9d-c106-4276-8b47-7460cca8860e	13
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	34686e9d-c106-4276-8b47-7460cca8860e	13
993557	24 HR bupropion hydrochloride 300 MG Extended Release Oral Tablet	SCD	34686e9d-c106-4276-8b47-7460cca8860e	13
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	34686e9d-c106-4276-8b47-7460cca8860e	13
993557	bupropion HCl XL 300 MG 24 HR Extended Release Oral Tablet	SY	34686e9d-c106-4276-8b47-7460cca8860e	13
993541	buPROPion HCl 150 MG 24HR Extended Release Oral Tablet	PSN	7c46d95a-26f6-4364-8197-9e564e3405f2	12
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	7c46d95a-26f6-4364-8197-9e564e3405f2	12
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	7c46d95a-26f6-4364-8197-9e564e3405f2	12
993541	buPROPion HCl 150 MG 24HR Extended Release Oral Tablet	PSN	77b78d35-40f5-4713-8468-aa09a6c2925d	9
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	77b78d35-40f5-4713-8468-aa09a6c2925d	9
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	77b78d35-40f5-4713-8468-aa09a6c2925d	9
993541	buPROPion HCl 150 MG 24HR Extended Release Oral Tablet	PSN	42e228a2-25b3-44a6-8da7-6616ca44ac7f	7
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	42e228a2-25b3-44a6-8da7-6616ca44ac7f	7
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	42e228a2-25b3-44a6-8da7-6616ca44ac7f	7
993541	buPROPion HCl 150 MG 24HR Extended Release Oral Tablet	PSN	f8af7829-8b61-6785-e053-6294a90af052	2
993541	buPROPion HCl 150 MG 24HR Extended Release Oral Tablet	PSN	df6093eb-2067-595f-e053-2995a90a5a6d	2
993541	buPROPion HCl 150 MG 24HR Extended Release Oral Tablet	PSN	d99d21b3-090d-4c4b-b152-30ccb9f46c40	2
993541	buPROPion HCl 150 MG 24HR Extended Release Oral Tablet	PSN	d21a792a-4556-bcc0-e053-2a95a90a3391	2
993541	buPROPion HCl 150 MG 24HR Extended Release Oral Tablet	PSN	42201f4a-8856-4499-8bc3-d18612b1ec34	2
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	f8af7829-8b61-6785-e053-6294a90af052	2
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	42201f4a-8856-4499-8bc3-d18612b1ec34	2
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	d21a792a-4556-bcc0-e053-2a95a90a3391	2
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	d99d21b3-090d-4c4b-b152-30ccb9f46c40	2
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	df6093eb-2067-595f-e053-2995a90a5a6d	2
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	f8af7829-8b61-6785-e053-6294a90af052	2
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	42201f4a-8856-4499-8bc3-d18612b1ec34	2
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	d21a792a-4556-bcc0-e053-2a95a90a3391	2
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	d99d21b3-090d-4c4b-b152-30ccb9f46c40	2
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	df6093eb-2067-595f-e053-2995a90a5a6d	2
993541	buPROPion HCl 150 MG 24HR Extended Release Oral Tablet	PSN	9af0fadd-0ef9-2317-e053-2a95a90a9a88	1
993541	buPROPion HCl 150 MG 24HR Extended Release Oral Tablet	PSN	29a6c6e3-f30f-6541-e063-6394a90ae11d	1
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	29a6c6e3-f30f-6541-e063-6394a90ae11d	1
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	9af0fadd-0ef9-2317-e053-2a95a90a9a88	1
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	9af0fadd-0ef9-2317-e053-2a95a90a9a88	1
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	29a6c6e3-f30f-6541-e063-6394a90ae11d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16729-443-10	16729044310	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-443-10)	2018-11-08	0000-00-00	No	No	Current
16729-443-15	16729044315	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-443-15)	2018-11-08	0000-00-00	No	No	Current
16729-443-16	16729044316	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-443-16)	2018-11-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	2026-07-24	HUMAN PRESCRIPTION DRUG LABEL	23
BUPROPION HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	2026-03-20	HUMAN PRESCRIPTION DRUG LABEL	7
BUPROPION HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	2026-02-25	HUMAN PRESCRIPTION DRUG LABEL	15
BUPROPION HYDROCHLORIDE	Accord Healthcare Inc. \| Intas Pharmaceuticals Ltd	2025-10-07	HUMAN PRESCRIPTION DRUG LABEL	13
BUPROPION	DIRECT RX	2025-01-22	HUMAN PRESCRIPTION DRUG LABEL	18
Bupropion HCL ER Tablets	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	2
BUPROPION HYDROCHLORIDE	Quality Care Products, LLC	2024-12-18	HUMAN PRESCRIPTION DRUG LABEL	3
BUPROPION HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	2024-12-18	HUMAN PRESCRIPTION DRUG LABEL	1
BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	2024-10-30	HUMAN PRESCRIPTION DRUG LABEL	10
BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	2024-08-29	HUMAN PRESCRIPTION DRUG LABEL	12
BUPROPION HYDROCHLORIDE	A-S Medication Solutions	2024-05-16	HUMAN PRESCRIPTION DRUG LABEL	9
BUPROPION HYDROCHLORIDE	RPK Pharmaceuticals, Inc.	2023-09-11	HUMAN PRESCRIPTION DRUG LABEL	2
BUPROPION HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	2023-07-17	HUMAN PRESCRIPTION DRUG LABEL	2
BUPROPION HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	2022-12-07	HUMAN PRESCRIPTION DRUG LABEL	2
BUPROPION HYDROCHLORIDE	Proficient Rx LP	2022-06-01	HUMAN PRESCRIPTION DRUG LABEL	2
BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	2021-12-23	HUMAN PRESCRIPTION DRUG LABEL	2
BUPROPION HYDROCHLORIDE	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2020-06-16	HUMAN PRESCRIPTION DRUG LABEL	2
BUPROPION HYDROCHLORIDE	medsource pharmaceuticals	2019-12-30	HUMAN PRESCRIPTION DRUG LABEL	1