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 3 of 180 · 3,600 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEREMEDYREPACK INC.bcbef1b4-a135-4231-bc65-7d0b335260e82026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Incd2d1428a-c8b5-9529-e053-2995a90a23432026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
S12 AIRBORNEALFALFA, ALLIUM SATIVUM, ARSENICUM IODATUM, BARLEY, BETULA PUBESCENS, BROWN RICE, CORN GRAIN, EUPHRASIA OFFICINALIS, FEATHER MIX, HAIR MIX, HISTAMINUM, HOUSE DUST MITE, LOLIUM PERENNE, OAT, PERFOLIATE HONEYSUCKLE, PHLEUM PRATENSE, POLLEN MIX, RYE, SABADILLA, SILICEA, SKIN MIX, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TEREBINTHINA, WHEATApex Energetics Inc.bb0036c3-1e4d-5750-e053-2995a90ae8952026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Stone Hand SanitizerISOPROPYL ALCOHOLhandetizer, LLC.59f821e0-b129-5c39-e063-6294a90a47a02026-08-26WarningsExact identifier
unii: ND2M416302
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEQuallent Pharmaceuticals Health LLC56df4e22-81ca-48a4-a8e2-0384484173552026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993541
unii: ZG7E5POY8O
Curad Alcohol Sterile, ThickISOPROPYL ALCOHOLMedline Industries, LPb769898e-a73f-4323-af15-bee8dbe455b62026-08-25WarningsExact identifier
unii: ND2M416302
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC334e5635-e4cc-cf2a-e063-6294a90ae1e12026-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: ETJ7Z6XBU4
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
Bupropion Hydrochloride (XL)BUPROPION HYDROCHLORIDEREMEDYREPACK INC.0cd6e0e2-6b2c-4e0d-b5b2-ebfe0d5e31c42026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993541
unii: ZG7E5POY8O
Psorinum ComplexPHOSPHORUS, SILICEA, SULPHUR, ALOEBioActive Nutritional, Inc.d4746927-e6d4-463d-a084-56ffc48d1e672026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Boneforce HPCALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALEBioActive Nutritional, Inc.d96ca52b-781d-431c-ad2a-a54fd57eb1062026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
inControl alcoholISOPROPYL ALCOHOLH-E-B45dfbd7a-0ae1-4146-9527-5483c884e6362026-08-18WarningsExact identifier
unii: ND2M416302
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: 6DC9Q167V3

Reported adverse events (FAERS/openFDA)#

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