FDA.reportPublic FDA data

NDC 80425-0300-01 - Bupropion hydrochloride

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
80425-0300
Requested NDC
80425-0300-01
Package NDCs from labels
80425-0300-1, 80425-0300-2, 80425-0300-3, 80425-0300-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Bupropion hydrochloride - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0300-1Bupropion hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE302
80425-0300-2Bupropion hydrochloride60 in 1 BOTTLETABLET, EXTENDED RELEASE602
80425-0300-3Bupropion hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0300BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20250102_f8af7829-8b61-6785-e053-6294a90af052.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0300-1EA - Each80425-030006c687a0-1094-4799-8d6b-b8ef329ae7fc12023-06-06
80425-0300-2EA - Each80425-030065286faa-05d1-4b75-b630-143099f5361812023-06-06
80425-0300-3EA - Each80425-03004c1c0dea-98d1-4af5-afb5-3243327e47a012023-06-06

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 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepackaf5b1cc8-f078-4a7b-b64a-4cb2de1e57212026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993541
unii: ZG7E5POY8O
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEBryant Ranch Prepackeb25adb1-9841-42ce-aa22-718fb0fba5dd2026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993541
unii: ZG7E5POY8O
Bupropion Hydrochloride (XL)BUPROPION HYDROCHLORIDEBryant Ranch Prepack8499470a-8d01-4348-b67b-8f49728031cb2026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993557
unii: ZG7E5POY8O
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepack5c111cf0-0199-4a4d-8138-81579af4c14d2026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepack4c9a5dc3-bebe-431a-b550-ce46c6c6b01e2026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEUnit Dose Solutions, Inc.53c192ca-ac51-cb87-e063-6394a90a6c082026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993557
unii: ZG7E5POY8O
bupropion HydrochlorideBUPROPION HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.434aacf8-87f1-44fc-a66b-92ae0022de0e2026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
bupropion hydrochloride SRBUPROPION HYDROCHLORIDEMajor Pharmaceuticals67b6bcf8-0e7c-4e74-ad72-54f1bd6e65ad2026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEProficient Rx LPf1703bfd-be36-4fde-8e67-df0fb5d933692026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993541
unii: ZG7E5POY8O
Bupropion Hydrochloride (XL)BUPROPION HYDROCHLORIDEBryant Ranch Prepackcefaaa17-f79a-4ba6-8f97-a59f60e07b752026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993541
unii: ZG7E5POY8O
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.f58ce435-b124-4519-98d8-de2d00f61b012026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEBryant Ranch Prepack6701af43-bf7d-45c4-a331-a18d16bd68f72026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEAmici Pharma, Inc.fbb587fa-75c0-4f4d-8eaf-f0e7ba8b5c752026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEBryant Ranch Prepack21be6b3b-add3-43e7-af93-30350aefc89e2026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEBryant Ranch Prepacka72db723-df4b-4bf4-9bdc-05ae820586962026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDECoupler LLC512b0ed3-db7d-b273-e063-6394a90a25cc2026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993541
unii: ZG7E5POY8O
bupropion HydrochlorideBUPROPION HYDROCHLORIDECoupler LLC507112bd-a082-e85a-e063-6294a90ab2ac2026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion HydrochlorideBUPROPION HYDROCHLORIDECardinal Health 107, LLC64934ca2-5655-45a2-9016-ad65b5abf5d32026-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion HydrochlorideBUPROPION HYDROCHLORIDECoupler LLC5038440c-1f32-715a-e063-6294a90a889d2026-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDECamber Pharmaceuticals, Inc.c71f18b7-36a3-4489-96b4-e8fbec4f73a12026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993557
rxcui: 993541
unii: ZG7E5POY8O

Reported adverse events (FAERS/openFDA)#

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