Bupropion Hydrochloride

Product NDC
50090-5334
11-digit product format
500905334
Labeler code
50090
Product ID
50090-5334_c799e3b4-7b1b-440e-ad0a-02eee6a2d8df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA210081
Marketing category
ANDA
Marketing start
2018-08-30
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
2026-12-31
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
A210081-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2017-11-03
A210081-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2017-11-03

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 06:07:402026-07A210081-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2017-11-03caaa826d4ba7…
2026-08-18 06:07:402026-07A210081-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2017-11-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210081-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2017-11-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210081-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2017-11-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210081-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2017-11-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210081-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2017-11-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A210081-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-11-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210081-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-11-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210081-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-11-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210081-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-11-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210081-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-11-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210081-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-11-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210081-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-11-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210081-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-11-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210081-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-11-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210081-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-11-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210081-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-11-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210081-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-11-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210081-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-11-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210081-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-11-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210081-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-11-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A210081-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-11-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210081-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-11-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210081-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-11-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210081-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-11-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210081-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-11-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210081-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-11-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210081-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-11-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210081-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-11-038072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210081-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-11-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210081-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-11-035c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210081-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-11-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210081-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-11-035d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210081-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-11-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210081-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-11-034b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210081-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-11-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210081-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-11-0374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210081-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-11-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210081-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-11-03bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210081-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-11-03bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-08-23 18:47 UTC2025-08A210081-001AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210081-002AB316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210081-001AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210081-002AB31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210081-001AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210081-002AB31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210081-001AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210081-002AB3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210081-001AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210081-002AB312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210081-001AB315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210081-002AB315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210081-001AB31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210081-002AB31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210081-001AB31d06236e962d9…
2024-10-29 15:01 UTC2024-10A210081-002AB31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210081-001AB3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210081-002AB3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210081-001AB31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210081-002AB31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210081-001AB311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210081-002AB311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210081-001AB318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210081-002AB318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210081-001AB315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210081-002AB315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210081-001AB315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210081-002AB315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210081-001AB314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210081-002AB314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210081-001AB3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210081-002AB3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210081-001AB31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210081-002AB31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210081-001AB31782e0a99824c…
2021-12-28 21:50 UTC2021-12A210081-002AB31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210081-001AB3187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210081-002AB3187673890dc5c…
2021-03-12 10:30 UTC2021-03A210081-001AB315aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A210081-002AB315aa47cf7b7d7…

Additional Listing Data#

Finished product
Yes
Brand name base
Bupropion Hydrochloride
Brand name suffix
(XL)
Listing expiration
2026-12-31

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
ef8ef9ba-ab2a-4af9-ac11-12dd1b603a4aAvailable 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5334-0Bupropion Hydrochloride(XL)30 in 1 BOTTLETABLET, EXTENDED RELEASE303
50090-5334-1Bupropion Hydrochloride(XL)90 in 1 BOTTLETABLET, EXTENDED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5334-0EA - Each50090-533413004834-457a-43c5-a813-3d52f906f7e712023-08-08
50090-5334-1EA - Each50090-533498cc7f4d-8d94-4863-8ebd-fd7a8727677512023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5334BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 2 package rows20230630_ef8ef9ba-ab2a-4af9-ac11-12dd1b603a4a.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupropion Hydrochloride (XL)BUPROPION HYDROCHLORIDEBryant Ranch Prepack9d5360f5-f747-4baf-8e6c-ddca1a9c871a2024-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210081
application number: ANDA210081
Bupropion Hydrochloride (XL)BUPROPION HYDROCHLORIDEBryant Ranch Prepack64be3113-837a-48f3-9f9e-400529c9ee942024-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210081
application number: ANDA210081
Bupropion Hydrochloride (XL)BUPROPION HYDROCHLORIDEA-S Medication Solutions62d0dcb5-c70b-4884-9755-740f62a8b31a2024-03-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210081
application number: ANDA210081
Bupropion Hydrochloride (XL)BUPROPION HYDROCHLORIDEA-S Medication Solutions8ae81b03-b447-4a3f-8ed9-ebf75ee52b492024-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210081
application number: ANDA210081
Bupropion Hydrochloride (XL)BUPROPION HYDROCHLORIDEA-S Medication Solutionsef8ef9ba-ab2a-4af9-ac11-12dd1b603a4a2023-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210081
application number: ANDA210081
ndc (product): 50090-5334
Bupropion Hydrochloride (XL)BUPROPION HYDROCHLORIDEProficient Rx LP2af578d8-a7f8-4da3-b126-390a0e950fad2022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210081
application number: ANDA210081

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNef8ef9ba-ab2a-4af9-ac11-12dd1b603a4a3
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDef8ef9ba-ab2a-4af9-ac11-12dd1b603a4a3
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYef8ef9ba-ab2a-4af9-ac11-12dd1b603a4a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5334-05009053340030 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5334-0) 2020-11-030000-00-00NoNoCurrent
50090-5334-15009053340190 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5334-1) 2020-11-030000-00-00NoNoCurrent