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 7 of 12 · 232 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEA-S Medication Solutions722650d8-5ee4-48ba-9827-7c86b12835222025-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993541
unii: ZG7E5POY8O
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEA-S Medication Solutions16ffe2ac-4f71-4843-99df-611f53c2f3cd2025-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993541
unii: ZG7E5POY8O
BUPROPION HYDROCHLORIDE SRBUPROPION HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.f5d774dd-0f51-4a4f-a9d1-8b5f2364b1f72025-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEAccord Healthcare Inc.34686e9d-c106-4276-8b47-7460cca8860e2025-10-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA210497
ndc (product): 16729-443
rxcui: 993557
rxcui: 993541
spl id: 4092a3ea-403d-7a91-e063-6394a90a8ddf
spl set id: 34686e9d-c106-4276-8b47-7460cca8860e
unii: ZG7E5POY8O
BUPROPION HYDROCHLORIDE (SR)BUPROPION HYDROCHLORIDEDr. Reddy's Laboratories Inc8069c521-c49a-4b6d-baa8-4b0be897d5852025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEAurobindo Pharma Limited6563b923-269f-40c3-b992-cbacdfca6e162025-09-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion HydrochlorideBUPROPION HYDROCHLORIDECoupler LLC3eec57be-b8ae-cdf8-e063-6394a90a694d2025-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEAlembic Pharmaceuticals Inc.b303a0ad-5971-44ab-937c-bcf3ff6503582025-09-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
bupropion HydrochlorideBUPROPION HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.9196568e-aec8-4d56-993e-4cbb78d4a3a62025-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEPreferred Pharmaceuticals Inc.069e6828-e599-4614-9645-9cf1382ac93e2025-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993541
unii: ZG7E5POY8O
bupropion hydrochlorideBUPROPION HYDROCHLORIDEUpsher-Smith Laboratories, LLC98d5977f-9b32-46db-bd36-a2c4d1b0710a2025-08-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion Hydrochloride (XL)BUPROPION HYDROCHLORIDEAdvanced Rx of Tennessee, LLC3d826804-6427-aae1-e063-6394a90a65932025-08-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993557
unii: ZG7E5POY8O
bupropion hydrochlorideBUPROPION HYDROCHLORIDEREMEDYREPACK INC.d087222e-c5e9-4c48-b27f-e2e2944379c82025-08-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993557
unii: ZG7E5POY8O
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDENuCare Pharmaceuticals,Inc.eeb3fed1-2202-09fc-e053-2995a90a9f632025-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepackf566f8b5-b3c1-4234-88bd-59a7b8dc801a2025-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepackfa5fa0d8-d27f-44e1-8868-dfa7206524e22025-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEA-S Medication Solutionsa0fdfc21-165a-43fa-9b3c-e48f3b8922502025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993557
unii: ZG7E5POY8O
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEA-S Medication Solutionseee88553-acff-4bdd-acd1-f39bcb6fcdca2025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993557
unii: ZG7E5POY8O
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepack2a13267f-c47f-4791-a8f9-4bbb5c8040272025-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepack1d722dc2-7909-454e-b989-0956770790442025-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O

Reported adverse events (FAERS/openFDA)#

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