FDA.reportPublic FDA data

NDC 80425-0304-01 - Sildenafil Citrate

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
80425-0304
Requested NDC
80425-0304-01
Package NDCs from labels
80425-0304-1, 80425-0304-2, 80425-0304-3, 80425-0304-4, 80425-0304-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-07-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sildenafil Citrate - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-07-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0304-1Sildenafil Citrate30 in 1 BOTTLETABLET302
80425-0304-2Sildenafil Citrate60 in 1 BOTTLETABLET602
80425-0304-3Sildenafil Citrate90 in 1 BOTTLETABLET902
80425-0304-4Sildenafil Citrate50 in 1 BOTTLETABLET502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0304SILDENAFIL CITRATE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 4 package rows20240711_f925abbe-4977-00b0-e053-6294a90a6e53.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0304-1EA - Each80425-0304dbcf4f92-e4ef-4ed1-b772-6cee3021394012023-06-06
80425-0304-2EA - Each80425-03041731c4f7-f230-4f39-94fa-b1fd5cbe673f12023-06-06
80425-0304-3EA - Each80425-03044b49ed95-0cb4-4ced-97a1-5e432137e30412023-06-06
80425-0304-4EA - Each80425-030496887e55-dffb-474c-9034-8e44f36d892a12024-08-12

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 4 of 8 · 158 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SildenafilSILDENAFILAvKARE21c83ff3-c359-3269-e063-6394a90a57ee2026-01-19Warnings, Adverse reactionsExact identifier
rxcui: 577033
unii: BW9B0ZE037
Sildenafil CitrateSILDENAFILAdvagen Pharma Ltdce683bbc-a1d2-4f23-b3d1-d9333d91dc552026-01-13Warnings, Adverse reactionsExact identifier
rxcui: 577033
unii: BW9B0ZE037
SILDENAFILSILDENAFILAdvagen Pharma Ltde671d887-2317-4c1c-9b68-e24cda3d3aef2026-01-07Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
SildenafilSILDENAFILNorthwind Health Company, LLCfa14cb6b-0fa8-0ba0-e053-6294a90afae32026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 577033
unii: BW9B0ZE037
SildenafilSILDENAFILNorthwind Health Company, LLCf3089ee6-190d-4749-e053-2a95a90a15d82026-01-01Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
Sildenafil CitrateSILDENAFILNorthwind Health Company, LLCd9ddfd2a-1961-90f9-e053-2a95a90a7f9b2026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 577033
unii: BW9B0ZE037
SILDENAFIL CITRATESILDENAFILNorthwind Health Company, LLCd9de0817-cac1-4ee5-e053-2a95a90a5fa72026-01-01Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
SildenafilSILDENAFILNuCare Pharmaceuticals, Inc.2916e6c4-bc68-c4d6-e063-6394a90aba792025-12-12Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
SildenafilSILDENAFILAmerican Health Packagingf7fbfc3b-807e-4375-a6eb-8db0eaf40c9c2025-11-20Warnings, Adverse reactionsExact identifier
rxcui: 577033
unii: BW9B0ZE037
SildenafilSILDENAFILAvPAKe08de794-9b7e-aae6-9c89-a0c0d090cc762025-11-12Warnings, Adverse reactionsExact identifier
rxcui: 577033
unii: BW9B0ZE037
SildenafilSILDENAFILQuallent Pharmaceuticals Health LLC333ca682-931f-4edb-95d6-2edbd87631cf2025-11-07Warnings, Adverse reactionsExact identifier
rxcui: 577033
unii: BW9B0ZE037
Sildenafil CitrateSILDENAFILQuallent Pharmaceuticals Health LLC41b67fd2-3d9a-49d6-88b8-285044b98dc12025-11-07Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
SildenafilSILDENAFILAjanta Pharma USA Inc.283790ed-2acb-4714-a0af-b348bb6427852025-11-05Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
SILDENAFIL CITRATESILDENAFIL CITRATEProficient Rx LP8780c159-8b61-402b-afbe-64f5c85d38862025-11-01Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
SILDENAFIL CITRATESILDENAFIL CITRATEProficient Rx LP30ce6e7f-716e-4a68-a4fb-2bb2d34ed0522025-11-01Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
SildenafilSILDENAFILNuCare Pharmaceuticals,Inc.41b2c017-53a0-c687-e063-6394a90a15b22025-10-21Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
SildenafilSILDENAFILAjanta Pharma USA Inc.31c0f8ab-ed2e-4ead-a8c0-4055f6c437832025-10-09Warnings, Adverse reactionsExact identifier
rxcui: 577033
unii: BW9B0ZE037
Sildenafil CitrateSILDENAFILAjanta Pharma USA Inc.2ccc6fa6-f8ae-4191-806f-a887244e516a2025-10-08Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
SildenafilSILDENAFILMacleods Pharmaceuticals Limitedc2b25818-99a3-474b-a04c-929df11108342025-09-17Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
SildenafilSILDENAFILProficient Rx LP71140bd5-0a51-4c01-ad0d-193d08ea67dd2025-09-01Warnings, Adverse reactionsExact identifier
application number: ANDA091479
rxcui: 577033
unii: BW9B0ZE037

Reported adverse events (FAERS/openFDA)#

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