Bupropion Hydrochloride

Product NDC
45963-142
11-digit product format
459630142
Labeler code
45963
Product ID
45963-142_50d33e34-1a33-4595-b06a-4da2f7d7d518
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA077285
Marketing category
ANDA
Marketing start
2015-02-17
Substance
BUPROPION HYDROCHLORIDE
Active strength
300 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
A077285-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-26
A077285-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32008-08-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077285-001AB3
A077285-002AB3

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 06:07:402026-07A077285-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-26caaa826d4ba7…
2026-08-18 06:07:402026-07A077285-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32008-08-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077285-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077285-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32008-08-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077285-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077285-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32008-08-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A077285-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077285-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32008-08-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077285-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077285-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32008-08-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077285-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077285-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32008-08-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077285-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077285-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32008-08-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077285-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077285-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32008-08-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077285-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077285-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32008-08-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077285-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077285-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32008-08-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077285-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A077285-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32008-08-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077285-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077285-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32008-08-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077285-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077285-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32008-08-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077285-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077285-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32008-08-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077285-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077285-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32008-08-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077285-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077285-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32008-08-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077285-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077285-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32008-08-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077285-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077285-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32008-08-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077285-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077285-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32008-08-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077285-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32008-11-26bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077285-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32008-08-15bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A077285-001AB31caaa826d4ba7…
2026-08-18 06:07:402026-07A077285-002AB31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077285-001AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077285-002AB31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077285-001AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077285-002AB3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077285-001AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077285-002AB316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077285-001AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077285-002AB31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077285-001AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077285-002AB31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077285-001AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077285-002AB3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077285-001AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077285-002AB312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077285-001AB315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077285-002AB315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077285-001AB31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077285-002AB31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077285-001AB31d06236e962d9…
2024-10-29 15:01 UTC2024-10A077285-002AB31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077285-001AB3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077285-002AB3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077285-001AB31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077285-002AB31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077285-001AB311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077285-002AB311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077285-001AB318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077285-002AB318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077285-001AB315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077285-002AB315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077285-001AB315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077285-002AB315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077285-001AB314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077285-002AB314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077285-001AB3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077285-002AB3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077285-001AB31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077285-002AB31bb7c543d1eb4…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE300 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
993557Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
df923448-4f81-47af-8e55-f7359746b05fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4eceb285-f3c7-4092-a21a-4c9f3169f20cProduct name520260220
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
548ba7fd-fd0c-4a21-b2b0-d01bf93143b8Product name320240209
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
b8ee525f-67fb-39fb-91da-7e47ac54581dProduct name520200611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
e4d463bc-c674-43cb-be06-82786f310d01Product name120150326
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
0916dcfb-331f-89b1-8eac-6f7dc76d82daProduct name120140508
d7fc3d53-5a6c-de82-2808-1780f175f17eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45963-142-05Bupropion Hydrochloride500 in 1 BOTTLETABLET, EXTENDED RELEASE50035
45963-142-30Bupropion Hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE3035
45963-142-90Bupropion Hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE9035

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45963-142-05EA - Each45963-142218cc341-887c-4540-8a32-e03862f05e3912015-06-09
45963-142-30EA - Each45963-1425abe8bc2-d7be-4256-97f1-817a295bfa4112015-03-03
45963-142-90EA - Each45963-142ea24e674-f155-46e4-b235-9cd96092955c12015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]7
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]7
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]7
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]7
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]7
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]7
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]7
POVIDONESINACTIVE INGREDIENTFZ989GH94EBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]7
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]7
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]7
TALCINACTIVE INGREDIENT7SEV7J4R1UBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]7
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]7
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45963-142BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]33Current NDC, Legacy NDC, 3 package rows20240625_df923448-4f81-47af-8e55-f7359746b05f.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 HydrochlorideBUPROPION HYDROCHLORIDEActavis Pharma, Inc.df923448-4f81-47af-8e55-f7359746b05f2026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077285
application number: ANDA077285
ndc (product): 45963-142
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEHAWAII REPACK, INC.b4a1d3b8-afcf-47e3-96d3-469d8f408a312025-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077285
application number: ANDA077285
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEAsclemed USA, Inc.637e89e5-8f6e-4392-8045-a778cb9ed1382025-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077285
application number: ANDA077285
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEProficient Rx LP9e2d9c1e-a1de-491d-8f64-34ae604196112022-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077285
application number: ANDA077285

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNdf923448-4f81-47af-8e55-f7359746b05f35
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDdf923448-4f81-47af-8e55-f7359746b05f35
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYdf923448-4f81-47af-8e55-f7359746b05f35
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN9e2d9c1e-a1de-491d-8f64-34ae604196115
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD9e2d9c1e-a1de-491d-8f64-34ae604196115
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY9e2d9c1e-a1de-491d-8f64-34ae604196115
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN7d776748-e0eb-dc9c-e053-2991aa0a88222
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN637e89e5-8f6e-4392-8045-a778cb9ed1382
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD7d776748-e0eb-dc9c-e053-2991aa0a88222
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD637e89e5-8f6e-4392-8045-a778cb9ed1382
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY7d776748-e0eb-dc9c-e053-2991aa0a88222
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY637e89e5-8f6e-4392-8045-a778cb9ed1382
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNb4a1d3b8-afcf-47e3-96d3-469d8f408a311
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN1b4b326e-64a2-4e1c-b16c-9190f4be4bb91
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD1b4b326e-64a2-4e1c-b16c-9190f4be4bb91
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDb4a1d3b8-afcf-47e3-96d3-469d8f408a311
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYb4a1d3b8-afcf-47e3-96d3-469d8f408a311
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY1b4b326e-64a2-4e1c-b16c-9190f4be4bb91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45963-142-0545963014205500 TABLET, EXTENDED RELEASE in 1 BOTTLE (45963-142-05) 2015-05-190000-00-00NoNoCurrent
45963-142-304596301423030 TABLET, EXTENDED RELEASE in 1 BOTTLE (45963-142-30) 2015-02-170000-00-00NoNoCurrent
45963-142-904596301429090 TABLET, EXTENDED RELEASE in 1 BOTTLE (45963-142-90) 2015-06-150000-00-00NoNoCurrent