FDA.reportPublic FDA data

NDC 70518-4056-01 - Bupropion Hydrochloride SR

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
70518-4056
Requested NDC
70518-4056-01
Package NDCs from labels
70518-4056-0, 70518-4056-1, 70518-4056-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-10-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Bupropion Hydrochloride SR - REMEDYREPACK INC.REMEDYREPACK INC.2026-10-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4056-0Bupropion HydrochlorideSR90 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE907
70518-4056-1Bupropion HydrochlorideSR30 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4056BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REMEDYREPACK INC.]4Current NDC, 2 package rows20250125_b47c5515-a438-40bc-b8ad-26a6cf9676b7.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 28 of 287 · 5,737 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leukotrap RC PL SystemCP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC54e9a497-7a94-44c9-e063-6294a90a84da2026-06-23Exact identifier
unii: IY9XDZ35W2
Leukotrap RC PL SystemCP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC54eb0462-cd00-4467-e063-6394a90aa3712026-06-23Exact identifier
unii: IY9XDZ35W2
Leukotrap RC SystemCP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC54eb3c81-5cc8-03c4-e063-6294a90a20652026-06-23Exact identifier
unii: IY9XDZ35W2
Leukotrap RC SystemCP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC54ebb700-3bcf-d0e3-e063-6394a90a57c82026-06-23Exact identifier
unii: IY9XDZ35W2
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 30 Body Lightweight, non-greasy feel 3 essential ceramides Mineral SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc54ecaea7-dafe-9694-e063-6394a90ae3b52026-06-23WarningsExact identifier
unii: 15FIX9V2JP
Family Beauty Hydrating Hand Sanitizer, Aloe ScentedALCOHOLFamily Dollar Stores, LLC394c35ad-90b1-476c-84b9-2dbf973444532026-06-23WarningsExact identifier
unii: 3K9958V90M
RYDEEN UV CLEARSUNSCREENGuangzhou Oupeng Cosmetics Co., Ltd.548000cd-1655-aeb3-e063-6294a90ad0042026-06-22WarningsExact identifier
unii: 15FIX9V2JP
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEREMEDYREPACK INC.c76f2f9f-3999-4bdd-8ec3-e0066318d3782026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205794
unii: ZG7E5POY8O
Smart Care Hand Sanitizers 2pk Cherry Blossom and French VanillaALCOHOLShenzhen Lantern Scicence Co.,Ltd.54e431cd-98fb-8346-e063-6294a90ad85e2026-06-22WarningsExact identifier
unii: 3K9958V90M
ESPOIR BE VELVET COVER CUSHIONHOMOSALATE, TITANIUM DIOXIDEESPOIR Corporation54ce2420-4ac0-eb51-e063-6294a90a2de92026-06-21WarningsExact identifier
unii: 15FIX9V2JP
Smart Care Holiday Hand Sanitizer-GingerbreadALCOHOLShenzhen Lantern Scicence Co.,Ltd.54cea78b-515c-9562-e063-6394a90af1b42026-06-21WarningsExact identifier
unii: 3K9958V90M
Smart Care Holiday Hand Sanitizer-MistletoeALCOHOLShenzhen Lantern Scicence Co.,Ltd.54cecbb4-5d85-dacf-e063-6294a90af8072026-06-21WarningsExact identifier
unii: 3K9958V90M
Smart Care Silicone Case for Hand Sanitizer BarbieALCOHOLShenzhen Lantern Scicence Co.,Ltd.54cef14d-dd2b-905f-e063-6294a90a66ba2026-06-21WarningsExact identifier
unii: 3K9958V90M
Smart Care Silicone Case for Hand Sanitizer MermicornoALCOHOLShenzhen Lantern Scicence Co.,Ltd.54cedd57-03a9-e5e5-e063-6394a90a486b2026-06-21WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizers 2pk Fresh Rain and Pumpkin SpiceALCOHOLShenzhen Lantern Scicence Co.,Ltd.54cf590a-2a74-d8fe-e063-6294a90a64382026-06-21WarningsExact identifier
unii: 3K9958V90M
BABIES KIDSSUN PROTECTIONMINERAL SUNSCREENPANERGYTEK USA INC3a554118-b71d-a844-e063-6294a90a699f2026-06-20WarningsExact identifier
unii: 15FIX9V2JP
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDENorthwind Health Company, LLC0865f8cf-1d7f-0e67-e063-6294a90a2f4d2026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205794
rxcui: 993518
unii: ZG7E5POY8O
Rohto Cool ReliefNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companydc8f1ff3-87ae-47ca-815f-5a0e34f8cf302026-06-19WarningsExact identifier
unii: 6OZP39ZG8H
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: 3NXW29V3WO
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: 3NXW29V3WO

Reported adverse events (FAERS/openFDA)#

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