bupropion

Product NDC: 68382-353
11-digit product format: 683820353
Labeler code: 68382
Product ID: 68382-353_00be046c-e051-4430-a967-3a0d4611da22
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bupropion
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Zydus Pharmaceuticals USA Inc.
Application: ANDA201567
Marketing category: ANDA
Marketing start: 2018-08-02
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
A201567-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2014-01-17
A201567-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2018-07-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201567-001	AB3
A201567-002	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	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`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	A201567-001	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201567-002	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201567-001	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201567-002	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201567-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201567-002	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201567-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201567-002	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201567-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201567-002	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201567-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201567-002	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201567-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201567-002	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201567-001	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201567-002	AB3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201567-001	AB3	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201567-002	AB3	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201567-001	AB3	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201567-002	AB3	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201567-001	AB3	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201567-002	AB3	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201567-001	AB3	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201567-002	AB3	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201567-001	AB3	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201567-002	AB3	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201567-001	AB3	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201567-002	AB3	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201567-001	AB3	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201567-002	AB3	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201567-001	AB3	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201567-002	AB3	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201567-001	AB3	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201567-002	AB3	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201567-001	AB3	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201567-002	AB3	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201567-001	AB3	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201567-002	AB3	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201567-001	AB3	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201567-002	AB3	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: bupropion
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
8d937ca3-3351-40f1-8192-348ba0c68162	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
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
68382-353-05	bupropion	500 in 1 BOTTLE	TABLET, EXTENDED RELEASE	500	20
68382-353-06	bupropion	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	20
68382-353-10	bupropion	1000 in 1 BOTTLE	TABLET, EXTENDED RELEASE	1000	20
68382-353-16	bupropion	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90	20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68382-353-05	EA - Each	68382-353	32778398-a905-4dd1-91ac-f0060f497127	1	2019-01-24
68382-353-06	EA - Each	68382-353	e50a50af-f878-4261-9f09-77a376d8db9c	1	2019-01-24
68382-353-16	EA - Each	68382-353	ba846cad-72d6-4d2e-b9e8-00560e285119	1	2019-01-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BUPROPION HYDROCHLORIDE	ACTIVE INGREDIENT	ZG7E5POY8O	BUPROPION TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	7
BUPROPION	ACTIVE MOIETY	01ZG3TPX31	BUPROPION TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	7
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	BUPROPION TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	7
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	BUPROPION TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	7
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	BUPROPION TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	7
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	BUPROPION TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	7
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	BUPROPION TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	7
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	BUPROPION TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BUPROPION TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	7
METHACRYLIC ACID	INACTIVE INGREDIENT	1CS02G8656	BUPROPION TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	7
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	BUPROPION TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	7
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	BUPROPION TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	7
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	BUPROPION TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	7
SHELLAC	INACTIVE INGREDIENT	46N107B71O	BUPROPION TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	7
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BUPROPION TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	7
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	BUPROPION TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68382-353	BUPROPION TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]	20	Current NDC, Legacy NDC, 4 package rows	20240525_8d937ca3-3351-40f1-8192-348ba0c68162.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
bupropion	BUPROPION	Zydus Lifesciences Limited	78d34aad-9d4f-48c4-91eb-536e31c6b6c9	2024-11-26		Exact identifier application applno (ANDA): 201567 application number: ANDA201567
bupropion	BUPROPION	Zydus Pharmaceuticals USA Inc.	8d937ca3-3351-40f1-8192-348ba0c68162	2024-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201567 application number: ANDA201567 ndc (product): 68382-353
bupropion	BUPROPION	Proficient Rx LP	47ceb7e1-b2f7-47f8-8b6a-85eea36606b8	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201567 application number: ANDA201567

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
ZG7E5POY8O	BUPROPION HYDROCHLORIDE	31677-93-7	BUPROPION HYDROCHLORIDE
01ZG3TPX31	BUPROPION	34911-55-2	bupropion

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	8d937ca3-3351-40f1-8192-348ba0c68162	20
993557	buPROPion HCl 300 MG 24HR Extended Release Oral Tablet	PSN	8d937ca3-3351-40f1-8192-348ba0c68162	20
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	8d937ca3-3351-40f1-8192-348ba0c68162	20
993557	24 HR bupropion hydrochloride 300 MG Extended Release Oral Tablet	SCD	8d937ca3-3351-40f1-8192-348ba0c68162	20
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	8d937ca3-3351-40f1-8192-348ba0c68162	20
993557	bupropion HCl XL 300 MG 24 HR Extended Release Oral Tablet	SY	8d937ca3-3351-40f1-8192-348ba0c68162	20

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-353-05	68382035305	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-353-05)	2018-08-02	0000-00-00	No	No	Current
68382-353-06	68382035306	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-353-06)	2018-08-02	0000-00-00	No	No	Current
68382-353-10	68382035310	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-353-10)	2018-08-02	0000-00-00	No	No	Current
68382-353-16	68382035316	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-353-16)	2018-08-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
bupropion	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2024-05-21	HUMAN PRESCRIPTION DRUG LABEL	20