Bupropion Hydrochloride

Product NDC
71610-346
Requested package NDC
71610-346-60
11-digit product format
716100346
Labeler code
71610
Product ID
71610-346_2c125891-ab03-4c4f-844e-c0f8de1d370c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA210081
Marketing category
ANDA
Marketing start
2018-08-30
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
2020-12-31
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 packagepackage71610-34671610-346-60IInactivated by FDA2026-08-17

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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…

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
71610-346-60Bupropion Hydrochloride(XL)90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-346-60EA - Each71610-3466c3ed56a-94ab-4fb4-8332-c5eef0e1d93712019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-346BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 1 package rows20191017_38aecc00-de96-4479-aa9b-5d09a1529642.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
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
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN38aecc00-de96-4479-aa9b-5d09a15296421
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD38aecc00-de96-4479-aa9b-5d09a15296421
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY38aecc00-de96-4479-aa9b-5d09a15296421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-346-607161003466090 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-346-60) 2019-09-270000-00-00NoNoCurrent