Bupropion Hydrochloride

Product NDC
0591-3331
11-digit product format
005913331
Labeler code
0591
Product ID
0591-3331_08ef0752-1fcf-418b-9b72-3fbab8b23058
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA077715
Marketing category
ANDA
Marketing start
2008-11-26
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077715-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-26
A077715-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077715-001AB3

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077715-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-26caaa826d4ba7…
2026-08-18 06:07:402026-07A077715-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077715-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077715-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077715-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077715-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A077715-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077715-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077715-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077715-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077715-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077715-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077715-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077715-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077715-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077715-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077715-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077715-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077715-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077715-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077715-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A077715-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077715-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077715-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077715-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077715-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077715-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077715-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077715-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077715-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077715-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077715-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077715-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077715-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077715-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077715-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077715-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077715-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077715-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-26bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077715-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2007-06-13bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A077715-001AB31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077715-001AB31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077715-001AB3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077715-001AB316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077715-001AB31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077715-001AB31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077715-001AB3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077715-001AB312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077715-001AB315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077715-001AB31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077715-001AB31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077715-001AB3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077715-001AB31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077715-001AB311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077715-001AB318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077715-001AB315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077715-001AB315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077715-001AB314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077715-001AB3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077715-001AB31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077715-001AB31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077715-001AB3187673890dc5c…
2021-03-12 10:30 UTC2021-03A077715-001AB315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077715-001AB318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077715-001AB31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077715-001AB313f01610625f2…
2019-09-15 20:21 UTC2019-09A077715-001AB31b00525d2431f…
2019-07-19 19:46 UTC2019-07A077715-001AB31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077715-001AB316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077715-001AB311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077715-001AB31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077715-001AB31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077715-001AB319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077715-001AB31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077715-001AB313f0d92c62455…
2023-05-13 08:27 UTC2023-05A077715-001AB31053a50430f4f…
2023-01-26 05:58 UTC2023-01A077715-001AB313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077715-001AB313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077715-001AB31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077715-001AB31e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Bupropion Hydrochloride
Brand name suffix
XL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE150 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ZG7E5POY8OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
993541Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a1e768fd-c28f-4b49-822d-ccc315b4099cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4eceb285-f3c7-4092-a21a-4c9f3169f20cProduct name520260220
548ba7fd-fd0c-4a21-b2b0-d01bf93143b8Product name320240209
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
b8ee525f-67fb-39fb-91da-7e47ac54581dProduct name520200611
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
e4d463bc-c674-43cb-be06-82786f310d01Product name120150326
0916dcfb-331f-89b1-8eac-6f7dc76d82daProduct name120140508
d7fc3d53-5a6c-de82-2808-1780f175f17eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-3331-05Bupropion HydrochlorideXL500 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE50039
0591-3331-19Bupropion HydrochlorideXL90 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE9039
0591-3331-30Bupropion HydrochlorideXL30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE3039

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-3331-05EA - Each0591-3331798bf2a9-e323-4d9a-9523-2d22fa28441012012-07-24
0591-3331-19EA - Each0591-333162edb842-536d-412e-a192-96b1c966c1b112012-07-24
0591-3331-30EA - Each0591-333115376217-9d7f-42c5-ba12-79b3d4211aa212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]23
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]23
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]23
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]23
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]23
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]23
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]23
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]23
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]23
TALCINACTIVE INGREDIENT7SEV7J4R1UBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]23
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]23
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]23
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE EXTENDED RELEASE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE EXTENDED RELEASE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUPROPION HYDROCHLORIDE EXTENDED RELEASE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
ETHYLCELLULOSEINACTIVE INGREDIENT7Z8S9VYZ4BBUPROPION HYDROCHLORIDE EXTENDED RELEASE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBUPROPION HYDROCHLORIDE EXTENDED RELEASE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PBUPROPION HYDROCHLORIDE EXTENDED RELEASE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JBUPROPION HYDROCHLORIDE EXTENDED RELEASE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUPROPION HYDROCHLORIDE EXTENDED RELEASE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUPROPION HYDROCHLORIDE EXTENDED RELEASE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1UBUPROPION HYDROCHLORIDE EXTENDED RELEASE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUPROPION HYDROCHLORIDE EXTENDED RELEASE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMBUPROPION HYDROCHLORIDE EXTENDED RELEASE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]4
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]4
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]4
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]4
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]4
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]4
TALCINACTIVE INGREDIENT7SEV7J4R1UBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]4
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]4
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]3
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]3
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]3
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]3
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]3
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]3
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]3
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]3
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
ETHYLCELLULOSEINACTIVE INGREDIENT7Z8S9VYZ4BBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-3331BUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]37Current NDC, Legacy NDC, 3 package rows20250422_a1e768fd-c28f-4b49-822d-ccc315b4099c.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEActavis Pharma, Inc.a1e768fd-c28f-4b49-822d-ccc315b4099c2026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077715
application number: ANDA077715
ndc (product): 0591-3331
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEAsclemed USA, Inc.d1d0872c-5b11-4e13-a401-b122348e0fa72026-03-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077715
application number: ANDA077715
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEA-S Medication Solutions9d08b4ae-077d-4cd8-9ca4-8d5cd63f400b2023-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077715
application number: ANDA077715
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEProficient Rx LPec9cbb38-1582-492f-a526-4b3675c55b142023-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077715
application number: ANDA077715

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNa1e768fd-c28f-4b49-822d-ccc315b4099c39
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDa1e768fd-c28f-4b49-822d-ccc315b4099c39
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYa1e768fd-c28f-4b49-822d-ccc315b4099c39
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNec9cbb38-1582-492f-a526-4b3675c55b145
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN82f5292b-b113-4f10-9469-04386fa8e9d45
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN7562d7e7-4dc3-44dc-a174-c0613feb3d6b5
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN82f5292b-b113-4f10-9469-04386fa8e9d45
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDec9cbb38-1582-492f-a526-4b3675c55b145
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD82f5292b-b113-4f10-9469-04386fa8e9d45
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD7562d7e7-4dc3-44dc-a174-c0613feb3d6b5
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD82f5292b-b113-4f10-9469-04386fa8e9d45
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYec9cbb38-1582-492f-a526-4b3675c55b145
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY7562d7e7-4dc3-44dc-a174-c0613feb3d6b5
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY82f5292b-b113-4f10-9469-04386fa8e9d45
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY82f5292b-b113-4f10-9469-04386fa8e9d45
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN9d08b4ae-077d-4cd8-9ca4-8d5cd63f400b4
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD9d08b4ae-077d-4cd8-9ca4-8d5cd63f400b4
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY9d08b4ae-077d-4cd8-9ca4-8d5cd63f400b4
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN23de55c2-c695-469e-9541-c377a8cef5c33
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN23de55c2-c695-469e-9541-c377a8cef5c33
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD23de55c2-c695-469e-9541-c377a8cef5c33
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD23de55c2-c695-469e-9541-c377a8cef5c33
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY23de55c2-c695-469e-9541-c377a8cef5c33
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY23de55c2-c695-469e-9541-c377a8cef5c33
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNd1d0872c-5b11-4e13-a401-b122348e0fa72
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDd1d0872c-5b11-4e13-a401-b122348e0fa72
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYd1d0872c-5b11-4e13-a401-b122348e0fa72
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN22009d23-999c-4fa6-bfe7-21395f5772361
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNaf94e1a9-fb47-4842-8cde-5b5f44fb83cd1
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN22009d23-999c-4fa6-bfe7-21395f5772361
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDaf94e1a9-fb47-4842-8cde-5b5f44fb83cd1
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD22009d23-999c-4fa6-bfe7-21395f5772361
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD22009d23-999c-4fa6-bfe7-21395f5772361
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY22009d23-999c-4fa6-bfe7-21395f5772361
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYaf94e1a9-fb47-4842-8cde-5b5f44fb83cd1
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY22009d23-999c-4fa6-bfe7-21395f5772361

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0591-3331-0500591333105500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-3331-05) 2008-11-260000-00-00NoNoCurrent
0591-3331-190059133311990 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-3331-19) 2008-11-260000-00-00NoNoCurrent
0591-3331-300059133313030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-3331-30) 2008-11-260000-00-00NoNoCurrent