BUPROPION HYDROCHLORIDE (XL)

Product NDC
61919-069
Requested package NDC
61919-069-60
11-digit product format
619190069
Labeler code
61919
Product ID
61919-069_9c5b0a2c-cf33-85e5-e053-2995a90a783b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPROPION HYDROCHLORIDE (XL)
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA206556
Marketing category
ANDA
Marketing start
2017-02-22
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage61919-06961919-069-60IInactivated by FDA2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 16 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A206556-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-08-26
A206556-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2016-08-26

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A206556-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-08-2684e616aacf4f…
2026-09-14 22:38:342026-08A206556-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2016-08-2684e616aacf4f…
2026-08-18 06:07:402026-07A206556-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-08-26caaa826d4ba7…
2026-08-18 06:07:402026-07A206556-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2016-08-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206556-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-08-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206556-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2016-08-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206556-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-08-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206556-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2016-08-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A206556-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-08-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206556-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2016-08-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206556-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-08-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206556-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2016-08-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206556-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-08-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206556-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2016-08-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206556-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-08-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206556-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2016-08-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206556-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-08-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206556-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2016-08-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206556-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-08-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206556-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2016-08-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206556-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-08-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206556-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2016-08-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206556-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-08-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A206556-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2016-08-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206556-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-08-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206556-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2016-08-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206556-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-08-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206556-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2016-08-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206556-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-08-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206556-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2016-08-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206556-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORAL2016-08-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206556-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORAL2016-08-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206556-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32016-08-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206556-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32016-08-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206556-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32016-08-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206556-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32016-08-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206556-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32016-08-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206556-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32016-08-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206556-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32016-08-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206556-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32016-08-2674a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206556-001AB315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206556-002AB315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206556-001AB315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206556-002AB315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206556-001AB314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206556-002AB314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206556-001AB3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206556-002AB3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206556-001AB31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206556-002AB31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206556-001AB31782e0a99824c…
2021-12-28 21:50 UTC2021-12A206556-002AB31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206556-001AB3187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206556-002AB3187673890dc5c…
2021-03-12 10:30 UTC2021-03A206556-001AB315aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A206556-002AB315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206556-001AB318869cabd3fbd…
2020-12-22 03:56 UTC2020-12A206556-002AB318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206556-001AB31c0c555d07b60…
2020-11-12 02:37 UTC2020-11A206556-002AB31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206556-001AB313f01610625f2…
2019-12-14 00:12 UTC2019-12A206556-002AB313f01610625f2…
2019-09-15 20:21 UTC2019-09A206556-001AB31b00525d2431f…
2019-09-15 20:21 UTC2019-09A206556-002AB31b00525d2431f…
2019-07-19 19:46 UTC2019-07A206556-001AB31ea99ee380514…
2019-07-19 19:46 UTC2019-07A206556-002AB31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206556-001AB316a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206556-002AB316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206556-001AB311c564ffb4f44…
2024-02-18 07:12 UTC2024-02A206556-002AB311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206556-001AB31ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A206556-002AB31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206556-001AB31a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206556-002AB31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206556-001AB319b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206556-002AB319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206556-001AB31a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206556-002AB31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206556-001AB313f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206556-002AB313f0d92c62455…

Reported adverse events (FAERS/openFDA)#

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

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-069-602023-01-30C16284748780-1f386c649-b046-0266-e053-dadaa90a7c1aBUPROPION HYDROCHLORIDE (XL)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-069-60BUPROPION HYDROCHLORIDE (XL)60 in 1 BOTTLETABLET, EXTENDED RELEASE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-069-60EA - Each61919-06990a2f86a-6961-41c1-8536-04e1dbe8e1c512017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-069BUPROPION HYDROCHLORIDE (XL) TABLET, EXTENDED RELEASE [DIRECT RX]2Legacy NDC, 1 package rows20200118_4920adc6-d913-71b4-e054-00144ff8d46c.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupropion Hydrochloride (XL)BUPROPION HYDROCHLORIDEProficient Rx LP80f4a4ef-8190-458d-af2e-5daaf32abc012023-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206556
application number: ANDA206556
Bupropion Hydrochloride (XL)BUPROPION HYDROCHLORIDEExelan Pharmaceuticals Inc.8a0781c0-e7d5-498e-b7d3-d6bd457f175f2023-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206556
application number: ANDA206556
Bupropion Hydrochloride (XL)BUPROPION HYDROCHLORIDECIPLA USA INC.,c2cf79d7-1aba-4391-980b-5e218781f7c62020-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206556
application number: ANDA206556

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN4920adc6-d913-71b4-e054-00144ff8d46c2
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD4920adc6-d913-71b4-e054-00144ff8d46c2
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY4920adc6-d913-71b4-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-069-606191900696060 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-069-60) 2017-02-220000-00-00NoNoCurrent