BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL)

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-11-26
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 11
Source: full-release
Hydrated at: 2026-05-31 21:18:16

Label at a glance#

Productbupropion

Active ingredientBUPROPION HYDROCHLORIDE

Label structure2 sections

Label contents#

Full prescribing information#

SPL MEDGUIDE SECTION

Manufactured by:

Cadila Healthcare Ltd.

India.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-780-05

Bupropion Hydrochloride Extended-release Tablets USP (XL), 300 mg

500 Tablets

Rx only

NDC 65841-836-05

Bupropion Hydrochloride Extended-release Tablets USP (XL), 150 mg

500 Tablets

Rx only

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
993541	buPROPion HCl 150 MG 24HR Extended Release Oral Tablet	PSN	11
993557	buPROPion HCl 300 MG 24HR Extended Release Oral Tablet	PSN	11
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	11
993557	24 HR bupropion hydrochloride 300 MG Extended Release Oral Tablet	SCD	11
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	11
993557	bupropion HCl XL 300 MG 24 HR Extended Release Oral Tablet	SY	11

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
BUPROPION Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

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
65841-780-05	bupropion	500 in 1 BOTTLE	TABLET, EXTENDED RELEASE	500	11
65841-780-06	bupropion	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	11
65841-780-10	bupropion	1000 in 1 BOTTLE	TABLET, EXTENDED RELEASE	1000	11
65841-780-16	bupropion	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90	11
65841-836-05	bupropion	500 in 1 BOTTLE	TABLET, EXTENDED RELEASE	500	11
65841-836-06	bupropion	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	11
65841-836-10	bupropion	1000 in 1 BOTTLE	TABLET, EXTENDED RELEASE	1000	11
65841-836-16	bupropion	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90	11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65841-780	BUPROPION TABLET, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]	11	Current NDC, Legacy NDC, 4 package rows	20241128_78d34aad-9d4f-48c4-91eb-536e31c6b6c9.zip
65841-836	BUPROPION TABLET, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]	11	Current NDC, Legacy NDC, 4 package rows	20241128_78d34aad-9d4f-48c4-91eb-536e31c6b6c9.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BUPROPION HYDROCHLORIDE	ACTIVE INGREDIENT	ZG7E5POY8O	2
BUPROPION	ACTIVE MOIETY	01ZG3TPX31	2
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	2
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	2
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	2
METHACRYLIC ACID	INACTIVE INGREDIENT	1CS02G8656	2
METHYL ALCOHOL	INACTIVE INGREDIENT	Y4S76JWI15	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	2
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

bupropion
BUPROPION HYDROCHLORIDE
HYPROMELLOSES
MAGNESIUM STEARATE
METHACRYLIC ACID
POLYETHYLENE GLYCOL, UNSPECIFIED
TRIETHYL CITRATE
POVIDONE
ETHYLCELLULOSES
SILICON DIOXIDE
BUTYL ALCOHOL
FERROSOFERRIC OXIDE
ISOPROPYL ALCOHOL
PROPYLENE GLYCOL
SHELLAC
AMMONIA

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65841-780	65841-780-06, 65841-780-16, 65841-780-05, 65841-780-10
65841-836	65841-836-06, 65841-836-16, 65841-836-05, 65841-836-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BUPROPION HYDROCHLORIDE	ZG7E5POY8O	ACTIB
HYPROMELLOSES	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
METHACRYLIC ACID	1CS02G8656	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
TRIETHYL CITRATE	8Z96QXD6UM	IACT
POVIDONE	FZ989GH94E	IACT
ETHYLCELLULOSES	7Z8S9VYZ4B	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
BUTYL ALCOHOL	8PJ61P6TS3	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SHELLAC	46N107B71O	IACT
AMMONIA	5138Q19F1X	IACT
BUPROPION HYDROCHLORIDE	ZG7E5POY8O	ACTIB
HYPROMELLOSES	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
METHACRYLIC ACID	1CS02G8656	IACT
TRIETHYL CITRATE	8Z96QXD6UM	IACT
POVIDONE	FZ989GH94E	IACT
ETHYLCELLULOSES	7Z8S9VYZ4B	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
BUTYL ALCOHOL	8PJ61P6TS3	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SHELLAC	46N107B71O	IACT
AMMONIA	5138Q19F1X	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 110 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL		173 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	TABLET, EXTENDED RELEASE / ORAL		160 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
BUTYL ALCOHOL	BUTYL ALCOHOL	8PJ61P6TS3	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET, EXTENDED RELEASE / ORAL	213.24 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, EXTENDED RELEASE / ORAL		1472 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, EXTENDED RELEASE / ORAL		1472 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
BUTYL ALCOHOL	BUTYL ALCOHOL	8PJ61P6TS3	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, EXTENDED RELEASE / ORAL	9 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, EXTENDED RELEASE / ORAL	9 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, EXTENDED RELEASE / ORAL		101 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL		173 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	TABLET, EXTENDED RELEASE / ORAL		160 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, EXTENDED RELEASE / ORAL		1472 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, EXTENDED RELEASE / ORAL	9 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	TABLET, EXTENDED RELEASE / ORAL		160 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	TABLET, EXTENDED RELEASE / ORAL		160 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, EXTENDED RELEASE / ORAL		101 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
BUTYL ALCOHOL	BUTYL ALCOHOL	8PJ61P6TS3	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET, EXTENDED RELEASE / ORAL	213.24 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, EXTENDED RELEASE / ORAL	9 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, EXTENDED RELEASE / ORAL		1472 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL		173 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, EXTENDED RELEASE / ORAL		450 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
BUTYL ALCOHOL	BUTYL ALCOHOL	8PJ61P6TS3	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	TABLET, EXTENDED RELEASE / ORAL		160 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	TABLET, EXTENDED RELEASE / ORAL		1120 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, EXTENDED RELEASE / ORAL	9 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	TABLET, EXTENDED RELEASE / ORAL		1120 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET, EXTENDED RELEASE / ORAL	213.24 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, EXTENDED RELEASE / ORAL		450 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, EXTENDED RELEASE / ORAL		1472 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, EXTENDED RELEASE / ORAL		450 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET, EXTENDED RELEASE / ORAL	213.24 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, EXTENDED RELEASE / ORAL		450 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, EXTENDED RELEASE / ORAL		101 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, EXTENDED RELEASE / ORAL		450 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
BUTYL ALCOHOL	BUTYL ALCOHOL	8PJ61P6TS3	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, EXTENDED RELEASE / ORAL		101 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET, EXTENDED RELEASE / ORAL	213.24 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, EXTENDED RELEASE / ORAL	9 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL		173 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, EXTENDED RELEASE / ORAL		450 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL		173 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET, EXTENDED RELEASE / ORAL	213.24 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET, EXTENDED RELEASE / ORAL	213.24 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	TABLET, EXTENDED RELEASE / ORAL		1120 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
ETHYLCELLULOSES	ETHYLCELLULOSE	7Z8S9VYZ4B	TABLET, EXTENDED RELEASE / ORAL		1120 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL		173 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET, EXTENDED RELEASE / ORAL	213.24 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, EXTENDED RELEASE / ORAL		1472 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 88 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
2026-10-15 13:18:30	2026-09	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201567-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2014-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201567-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-07-23	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A201567-001	AB3	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201567-002	AB3	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A201567-001	AB3	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201567-002	AB3	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201567-001	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201567-002	AB3	1	`caaa826d4ba7…`
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…`

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 · 1 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 ndc (package): 65841-780-06 ndc (package): 65841-780-05 ndc (package): 65841-836-06 ndc (package): 65841-836-16 ndc (package): 65841-836-10 ndc (package): 65841-836-05 ndc (package): 65841-780-16 ndc (package): 65841-780-10 ndc (product): 65841-780 ndc (product): 65841-836 ndc11 (package): 65841078005 ndc11 (package): 65841083616 ndc11 (package): 65841083610 ndc11 (package): 65841078010 ndc11 (package): 65841078006 ndc11 (package): 65841078016 ndc11 (package): 65841083606 ndc11 (package): 65841083605 spl id: 6c831525-a7c2-4ef1-b1b9-c7e8cb807ded spl set id: 78d34aad-9d4f-48c4-91eb-536e31c6b6c9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.