FDA.reportPublic FDA data

NDC 50090-4049-01 - Bupropion Hydrochloride XL

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
50090-4049
Requested NDC
50090-4049-01
Package NDCs from labels
50090-4049-1, 50090-4049-2, 50090-4049-0, 50090-4049-01
Manufacturer
A-S Medication Solutions
Effective date
2023-08-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Bupropion Hydrochloride XL - A-S Medication SolutionsA-S Medication Solutions2023-08-08HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4049-02023-08-09C16284748780-1f386c649-afc5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL). BUPROPION HYDROCHLORIDE extended-release tablets (XL), for oral use Initial U.S. Approval: 1985
50090-4049-02023-01-30C16284748780-1f386c649-afc5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL). BUPROPION HYDROCHLORIDE extended-release tablets (XL), for oral use Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4049-0Bupropion HydrochlorideXL90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE904
50090-4049-1Bupropion HydrochlorideXL30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE304
50090-4049-2Bupropion HydrochlorideXL60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4049BUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]4Current NDC, Legacy NDC, 3 package rows20230810_9d08b4ae-077d-4cd8-9ca4-8d5cd63f400b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4049-0EA - Each50090-404915241165-31ba-4a87-b802-e9cfd3bbe41312023-09-05
50090-4049-1EA - Each50090-404963cc627c-91da-4a1b-a06e-57a4109ec57612023-09-05
50090-4049-2EA - Each50090-404908fe4463-1f51-4d4f-ae85-66644e0daafe12023-09-05

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 2 of 180 · 3,600 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Signature Select Alcohol Prep PadsISOPROPYL ALCOHOLBetter Living Brands LLC31ce72e3-03a3-1608-e063-6394a90ad8502026-09-03WarningsExact identifier
unii: ND2M416302
SurviveX Sting ReliefSTING RELIEF WIPEChangzhou Maokang Medical Products Co., Ltd.5a83b1f1-c8dc-cf07-e063-6394a90a20ca2026-09-03WarningsExact identifier
unii: ND2M416302
SurviveX Antiseptic WipesBZK ANTISEPTIC CLEANING WIPEChangzhou Maokang Medical Products Co., Ltd.5a82d9fb-dff8-1c89-e063-6394a90a32c92026-09-03WarningsExact identifier
unii: ND2M416302
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEREMEDYREPACK INC.81d251aa-a8e8-493e-94ed-12f6fb8902e62026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
AlcoholISOPROPYL ALCOHOLRite Aid Corporation5104f9ab-0b28-449f-a55a-5438713a24df2026-09-02WarningsExact identifier
unii: ND2M416302
AlcoholISOPROPYL ALCOHOLThe Kroger Company6551187f-5cde-4149-931f-b057bd7607502026-09-02WarningsExact identifier
unii: ND2M416302
Harris TeeterISOPROPYL ALCOHOLHarris Teeter, LLCd2bb20bd-ec83-8d80-e053-2a95a90a2bba2026-09-02WarningsExact identifier
unii: ND2M416302
School HealthISOPROPYL ALCOHOLSchool Health Corporationdb5d0b22-f2d7-23e5-e053-2a95a90aeb512026-09-02WarningsExact identifier
unii: ND2M416302
Alcohol Prep PadsISOPROPYL ALCOHOLTopco Associates2642298f-607e-fdca-e063-6394a90a69d92026-09-02WarningsExact identifier
unii: ND2M416302
Medline Alcohol Swabstick TriplesISOPROPYL ALCOHOLMedline Industries, LPe7759368-97c5-4b10-9bca-c197aeb62e462026-09-01WarningsExact identifier
unii: ND2M416302
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
70% Isopropyl AlcoholISOPROPYL ALCOHOLUpLift Brands, LLC8ae12375-3a95-475c-9600-17c51a9103f72026-08-31Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Bupropion HCL ER(SR)BUPROPION HCL ER(SR)DriectRx50afb442-e7c6-d28c-e063-6294a90a2b7e2026-08-31Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEGranules Pharmaceuticals Inc.d9eb0939-63c1-48c4-a444-a899d7924d062026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993541
unii: ZG7E5POY8O
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEREMEDYREPACK INC.0b041720-a25d-403e-a72c-601a8bdd80512026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEREMEDYREPACK INC.b47c5515-a438-40bc-b8ad-26a6cf9676b72026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEREMEDYREPACK INC.6087100f-3ba4-412e-b08d-768d1dcdaf002026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEREMEDYREPACK INC.0aa86bd6-b37b-45f7-a837-b067e41184e92026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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