Bupropion

Product NDC
67046-699
11-digit product format
670460699
Labeler code
67046
Product ID
67046-699_65067909-4e70-63b5-e053-2991aa0ae8a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Coupler Enterprises Inc
Application
ANDA090693
Marketing category
ANDA
Marketing start
2017-02-14
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67046-699IInactivated by FDA2026-08-10
excluded packagepackage67046-69967046-699-30IInactivated by FDA2026-08-10

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67046-699-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67046-699-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67046-699-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67046-699-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67046-699-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67046-699-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67046-699-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67046-699-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67046-699-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67046-699-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67046-699-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67046-699-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67046-699-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67046-699-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67046-699-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage67046-699-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage67046-699-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage67046-699-30bd6a592717d7…303034d00443…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A090693-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-06
A090693-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090693-001AB3
A090693-002AB3

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090693-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090693-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090693-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090693-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A090693-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090693-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090693-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090693-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090693-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090693-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090693-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090693-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090693-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090693-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090693-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090693-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090693-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090693-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090693-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A090693-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090693-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090693-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090693-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090693-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090693-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090693-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090693-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-068072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090693-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090693-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-065c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090693-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090693-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-065d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090693-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090693-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-064b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090693-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090693-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-0674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090693-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090693-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-06bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090693-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090693-001BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB32017-04-06782e0a99824c…
2021-12-28 21:50 UTC2021-12A090693-002BUPROPION HYDROCHLORIDE300MGTABLET, EXTENDED RELEASE / ORALAB32017-04-06782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090693-001AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090693-002AB31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090693-001AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090693-002AB3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090693-001AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090693-002AB316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090693-001AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090693-002AB31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090693-001AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090693-002AB31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090693-001AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090693-002AB3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090693-001AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090693-002AB312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090693-001AB315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090693-002AB315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090693-001AB31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090693-002AB31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090693-001AB31d06236e962d9…
2024-10-29 15:01 UTC2024-10A090693-002AB31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090693-001AB3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090693-002AB3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090693-001AB31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090693-002AB31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090693-001AB311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090693-002AB311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090693-001AB318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090693-002AB318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090693-001AB315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090693-002AB315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090693-001AB315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090693-002AB315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090693-001AB314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090693-002AB314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090693-001AB3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090693-002AB3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090693-001AB31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090693-002AB31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090693-001AB31782e0a99824c…
2021-12-28 21:50 UTC2021-12A090693-002AB31782e0a99824c…

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67046-699-302022-01-28C16284748780-1d6a99b39-e9f2-a426-e053-dadaa90af4c2699 Bupropion XL 150MG

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-699-30BupropionXL30 in 1 BLISTER PACKTABLET, EXTENDED RELEASE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-699BUPROPION XL (BUPROPION) TABLET, EXTENDED RELEASE [COUPLER ENTERPRISES INC]1Legacy NDC, 1 package rows20180212_650659e9-e160-1d04-e053-2a91aa0ae49a.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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEMajor Pharmaceuticalsaa3d3e5b-74a3-47f6-b9aa-d6e248e950e52026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090693
application number: ANDA090693
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEREMEDYREPACK INC.740534d3-59b5-4938-8e38-16275a14438c2026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090693
application number: ANDA090693
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDELupin Pharmaceuticals, Inc.1af14d2e-c64d-44b7-a402-8869e8e306612026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090693
application number: ANDA090693
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDECoupler LLC512b0ed3-db7d-b273-e063-6394a90a25cc2026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090693
application number: ANDA090693
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEREMEDYREPACK INC.bcbef1b4-a135-4231-bc65-7d0b335260e82026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090693
application number: ANDA090693
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEQuallent Pharmaceuticals Health LLC56df4e22-81ca-48a4-a8e2-0384484173552026-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090693
application number: ANDA090693
Bupropion HCL ER (XL)BUPROPION HCL ER (XL)Direct_Rx116cc898-66d6-e3a9-e063-6294a90a67fb2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090693
application number: ANDA090693
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEA-S Medication Solutions039d4368-c764-463a-b0cd-1cac702b8fb22026-02-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090693
application number: ANDA090693
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEA-S Medication Solutions6902b252-dc69-4b3c-bad2-b6667a5f6d842026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090693
application number: ANDA090693
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDENorthwind Health Company, LLCf2b30440-0e07-2670-e053-2995a90afa282026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090693
application number: ANDA090693
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDENuCare Pharmaceuticals, Inc.458c8a67-4995-c772-e063-6394a90a1f8d2025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090693
application number: ANDA090693
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDENuCare Pharmaceuticals,Inc.45789ff4-af5d-96b0-e063-6394a90a06442025-12-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090693
application number: ANDA090693
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEA-S Medication Solutionsa0fdfc21-165a-43fa-9b3c-e48f3b8922502025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090693
application number: ANDA090693
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEA-S Medication Solutionseee88553-acff-4bdd-acd1-f39bcb6fcdca2025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090693
application number: ANDA090693
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEAmerican Health Packaging8dab6d17-bf41-4a28-90db-b66959c0e1432025-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090693
application number: ANDA090693
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEAvPAK2f9c5162-a6c5-e362-e063-6294a90a198d2025-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090693
application number: ANDA090693
Bupropion HydrochlorideBUPROPION HYDROCHLORIDENuCare Pharmaceuticals,Inc.0e8b2109-8516-2d92-e063-6394a90a5d162025-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090693
application number: ANDA090693

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN650659e9-e160-1d04-e053-2a91aa0ae49a1
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD650659e9-e160-1d04-e053-2a91aa0ae49a1
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY650659e9-e160-1d04-e053-2a91aa0ae49a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67046-699-306704606993030 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-699-30) 2017-02-140000-00-00NoNoCurrent