Bupropion hydrochloride

Product NDC
63187-052
11-digit product format
631870052
Labeler code
63187
Product ID
63187-052_73572f20-b22c-4c8c-b99e-5eb8e70f9be0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078866
Marketing category
ANDA
Marketing start
2010-04-08
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078866-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-04-06
A078866-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-04-06
A078866-003BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-04-06

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078866-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-04-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078866-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-04-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078866-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-04-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078866-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-04-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078866-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-04-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078866-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-04-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A078866-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-04-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078866-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-04-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078866-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-04-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078866-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-04-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078866-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-04-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078866-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-04-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078866-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-04-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078866-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-04-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078866-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-04-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078866-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-04-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078866-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-04-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078866-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-04-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078866-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-04-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078866-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-04-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078866-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-04-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078866-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-04-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078866-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-04-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078866-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-04-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078866-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-04-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078866-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-04-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078866-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-04-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078866-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-04-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A078866-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-04-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A078866-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-04-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078866-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-04-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078866-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2010-04-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078866-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-04-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078866-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-04-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078866-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12010-04-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078866-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-04-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078866-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-04-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078866-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12010-04-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078866-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORAL2010-04-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078866-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORAL2010-04-068072bd15b7f6…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078866-002AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078866-002AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078866-002AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078866-003AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078866-001AB115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078866-002AB115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078866-003AB115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078866-001AB115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078866-002AB115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078866-003AB115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078866-001AB114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078866-002AB114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078866-003AB114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078866-001AB1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078866-002AB1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078866-003AB1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078866-001AB11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078866-002AB11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078866-003AB11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078866-001AB11782e0a99824c…
2021-12-28 21:50 UTC2021-12A078866-002AB11782e0a99824c…
2021-12-28 21:50 UTC2021-12A078866-003AB11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078866-001AB1187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078866-002AB1187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078866-003AB1187673890dc5c…
2021-03-12 10:30 UTC2021-03A078866-001AB115aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A078866-002AB115aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A078866-003AB115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078866-001AB118869cabd3fbd…
2020-12-22 03:56 UTC2020-12A078866-002AB118869cabd3fbd…
2020-12-22 03:56 UTC2020-12A078866-003AB118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078866-001AB11c0c555d07b60…
2020-11-12 02:37 UTC2020-11A078866-002AB11c0c555d07b60…
2020-11-12 02:37 UTC2020-11A078866-003AB11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078866-001AB113f01610625f2…
2019-12-14 00:12 UTC2019-12A078866-002AB113f01610625f2…
2019-12-14 00:12 UTC2019-12A078866-003AB113f01610625f2…
2019-09-15 20:21 UTC2019-09A078866-001AB11b00525d2431f…
2019-09-15 20:21 UTC2019-09A078866-002AB11b00525d2431f…
2019-09-15 20:21 UTC2019-09A078866-003AB11b00525d2431f…

Additional Listing Data#

Finished product
Yes
Brand name base
Bupropion hydrochloride
Listing expiration
2026-12-31

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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
993503Internal RxNorm lookup
993518Internal RxNorm lookup
993536Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d4272e3f-78ee-4d80-b911-e840fb14acbeAvailable 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
b8ee525f-67fb-39fb-91da-7e47ac54581dProduct name520200611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
e4d463bc-c674-43cb-be06-82786f310d01Product name120150326
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
0916dcfb-331f-89b1-8eac-6f7dc76d82daProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
d7fc3d53-5a6c-de82-2808-1780f175f17eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-052-30Bupropion hydrochloride30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE305
63187-052-60Bupropion hydrochloride60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE605
63187-052-78Bupropion hydrochloride180 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1805

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-052-30EA - Each63187-05256401619-ce0a-40b9-b29f-69c8ab8cc81712023-08-08
63187-052-60EA - Each63187-052d36379f8-8edf-4053-b3d6-5fa2688b993d12023-09-05
63187-052-78EA - Each63187-05240501c8e-0acc-4df2-a119-490db3ef311212023-08-08

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-052BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]5Current NDC, Legacy NDC, 3 package rows20191008_d4272e3f-78ee-4d80-b911-e840fb14acbe.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupropion hydrochlorideBUPROPION HYDROCHLORIDESun Pharmaceutical Industries, Inc.29848192-7de3-4c0d-a822-1268dcf128b02024-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078866
application number: ANDA078866
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEProficient Rx LPd4272e3f-78ee-4d80-b911-e840fb14acbe2019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078866
application number: ANDA078866
ndc (product): 63187-052

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSNd4272e3f-78ee-4d80-b911-e840fb14acbe5
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSNd4272e3f-78ee-4d80-b911-e840fb14acbe5
993536buPROPion HCl 200 MG 12HR Extended Release Oral TabletPSNd4272e3f-78ee-4d80-b911-e840fb14acbe5
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCDd4272e3f-78ee-4d80-b911-e840fb14acbe5
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDd4272e3f-78ee-4d80-b911-e840fb14acbe5
99353612 HR bupropion hydrochloride 200 MG Extended Release Oral TabletSCDd4272e3f-78ee-4d80-b911-e840fb14acbe5
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSYd4272e3f-78ee-4d80-b911-e840fb14acbe5
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSYd4272e3f-78ee-4d80-b911-e840fb14acbe5
993536bupropion hydrochloride 200 MG 12 HR Extended Release Oral TabletSYd4272e3f-78ee-4d80-b911-e840fb14acbe5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-052-306318700523030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-052-30) 2014-05-010000-00-00NoNoCurrent
63187-052-606318700526060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-052-60) 2014-05-010000-00-00NoNoCurrent
63187-052-7863187005278180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-052-78) 2014-05-010000-00-00NoNoCurrent