Bupropion hydrochloride

Product NDC: 47335-738
11-digit product format: 473350738
Labeler code: 47335
Product ID: 47335-738_b8e6ae63-c5d7-4481-b7b0-17e135670515
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bupropion hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA078866
Marketing category: ANDA
Marketing start: 2020-03-01
Substance: BUPROPION HYDROCHLORIDE
Active strength: 200 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A078866-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2010-04-06
A078866-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2010-04-06
A078866-003	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2010-04-06

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	A078866-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078866-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078866-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078866-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078866-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078866-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078866-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078866-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078866-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078866-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078866-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078866-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078866-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078866-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078866-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078866-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078866-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078866-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078866-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078866-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078866-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078866-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078866-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078866-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078866-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078866-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078866-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078866-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078866-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078866-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078866-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078866-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078866-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078866-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078866-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2010-04-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078866-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078866-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078866-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2010-04-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078866-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078866-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-06	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078866-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078866-002	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078866-002	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078866-003	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078866-001	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078866-002	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078866-003	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078866-001	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078866-002	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078866-003	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078866-001	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078866-002	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078866-003	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078866-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078866-002	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078866-003	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078866-001	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078866-002	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078866-003	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078866-001	AB1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078866-002	AB1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078866-003	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078866-001	AB1	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078866-002	AB1	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078866-003	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078866-001	AB1	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078866-002	AB1	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078866-003	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078866-001	AB1	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078866-002	AB1	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078866-003	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078866-001	AB1	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078866-002	AB1	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078866-003	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078866-001	AB1	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078866-002	AB1	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078866-003	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078866-001	AB1	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078866-002	AB1	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078866-003	AB1	1	`b00525d2431f…`

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	200 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
993503	Internal RxNorm lookup
993518	Internal RxNorm lookup
993536	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
29848192-7de3-4c0d-a822-1268dcf128b0	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
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
b8ee525f-67fb-39fb-91da-7e47ac54581d	Product name	5	20200611
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
47335-738-08	Bupropion hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100	16
47335-738-13	Bupropion hydrochloride	500 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	500	16
47335-738-86	Bupropion hydrochloride	60 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	60	16
47335-738-88	Bupropion hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
47335-738-86	EA - Each	47335-738	084f7291-73a2-4908-8448-cdba550db8f5	1	2012-07-24
47335-738-88	EA - Each	47335-738	4c88411d-8ed4-4537-9a51-ac9a5052d88e	1	2022-02-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BUPROPION HYDROCHLORIDE	ACTIVE INGREDIENT	ZG7E5POY8O	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	7
BUPROPION	ACTIVE MOIETY	01ZG3TPX31	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	7
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	7
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	7
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	7
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	7
SACCHARIN	INACTIVE INGREDIENT	FST467XS7D	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	7
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	7
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	7
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]	7
BUPROPION HYDROCHLORIDE	ACTIVE INGREDIENT	ZG7E5POY8O	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]	3
BUPROPION	ACTIVE MOIETY	01ZG3TPX31	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]	3
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]	3
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]	3
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]	3
SACCHARIN	INACTIVE INGREDIENT	FST467XS7D	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]	3
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47335-738	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]	16	Current NDC, Legacy NDC, 4 package rows	20241210_29848192-7de3-4c0d-a822-1268dcf128b0.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	29848192-7de3-4c0d-a822-1268dcf128b0	2024-12-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078866 application number: ANDA078866 ndc (product): 47335-738
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Proficient Rx LP	d4272e3f-78ee-4d80-b911-e840fb14acbe	2019-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078866 application number: ANDA078866

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
993503	buPROPion HCl 100 MG 12HR Extended Release Oral Tablet	PSN	29848192-7de3-4c0d-a822-1268dcf128b0	16
993518	buPROPion HCl 150 MG 12HR Extended Release Oral Tablet	PSN	29848192-7de3-4c0d-a822-1268dcf128b0	16
993536	buPROPion HCl 200 MG 12HR Extended Release Oral Tablet	PSN	29848192-7de3-4c0d-a822-1268dcf128b0	16
993503	12 HR bupropion hydrochloride 100 MG Extended Release Oral Tablet	SCD	29848192-7de3-4c0d-a822-1268dcf128b0	16
993518	12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	29848192-7de3-4c0d-a822-1268dcf128b0	16
993536	12 HR bupropion hydrochloride 200 MG Extended Release Oral Tablet	SCD	29848192-7de3-4c0d-a822-1268dcf128b0	16
993503	bupropion HCl 100 MG 12 HR Extended Release Oral Tablet	SY	29848192-7de3-4c0d-a822-1268dcf128b0	16
993518	bupropion HCl 150 MG 12 HR Extended Release Oral Tablet	SY	29848192-7de3-4c0d-a822-1268dcf128b0	16
993536	bupropion hydrochloride 200 MG 12 HR Extended Release Oral Tablet	SY	29848192-7de3-4c0d-a822-1268dcf128b0	16
993503	buPROPion HCl 100 MG 12HR Extended Release Oral Tablet	PSN	d4272e3f-78ee-4d80-b911-e840fb14acbe	5
993518	buPROPion HCl 150 MG 12HR Extended Release Oral Tablet	PSN	d4272e3f-78ee-4d80-b911-e840fb14acbe	5
993536	buPROPion HCl 200 MG 12HR Extended Release Oral Tablet	PSN	d4272e3f-78ee-4d80-b911-e840fb14acbe	5
993503	12 HR bupropion hydrochloride 100 MG Extended Release Oral Tablet	SCD	d4272e3f-78ee-4d80-b911-e840fb14acbe	5
993518	12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	d4272e3f-78ee-4d80-b911-e840fb14acbe	5
993536	12 HR bupropion hydrochloride 200 MG Extended Release Oral Tablet	SCD	d4272e3f-78ee-4d80-b911-e840fb14acbe	5
993503	bupropion HCl 100 MG 12 HR Extended Release Oral Tablet	SY	d4272e3f-78ee-4d80-b911-e840fb14acbe	5
993518	bupropion HCl 150 MG 12 HR Extended Release Oral Tablet	SY	d4272e3f-78ee-4d80-b911-e840fb14acbe	5
993536	bupropion hydrochloride 200 MG 12 HR Extended Release Oral Tablet	SY	d4272e3f-78ee-4d80-b911-e840fb14acbe	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
47335-738-08	47335073808	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-738-08)	2020-03-01	0000-00-00	No	No	Current
47335-738-13	47335073813	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-738-13)	2020-03-01	0000-00-00	No	No	Current
47335-738-86	47335073886	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-738-86)	2020-03-01	0000-00-00	No	No	Current
47335-738-88	47335073888	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-738-88)	2020-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bupropion hydrochloride	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited	2024-12-09	Human Prescription Drug Label	16
Bupropion Hydrochloride Extended-Release Tablets, USP (SR)	Proficient Rx LP	2019-10-01	HUMAN PRESCRIPTION DRUG LABEL	5