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 7 of 8 · 158 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SildenafilSILDENAFIL POWDER,Camber Pharmaceuticals, Inc.598f2b9c-cfb9-4f26-8508-83ca5055c3052024-03-13Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
SildenafilSILDENAFILChartwell RX, LLCfcc9e04d-3507-4429-9ddd-c1fdee8acdbf2024-03-12Warnings, Adverse reactionsExact identifier
rxcui: 577033
unii: BW9B0ZE037
sildenafilSILDENAFILVirtus Pharmaceuticals, LLC8526e8f2-4bb4-430b-9e38-68ee68caa5a42024-01-30Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
SildenafilSILDENAFIL CITRATEANI Pharmaceuticals, Inc.083da718-e934-4941-b083-a19b4ebe39352024-01-22Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
sildenafil citrateSILDENAFIL CITRATENovadoz Pharmaceuticals LLC18b327c1-19c9-4e33-ae02-de7cc900149c2024-01-01Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
Sildenafil CitrateSILDENAFILProficient Rx LP88825206-1b91-4d95-876c-71100912d3782024-01-01Warnings, Adverse reactionsExact identifier
rxcui: 577033
unii: BW9B0ZE037
SILDENAFILSILDENAFILLupin Pharmaceuticals, Inc.407ee7fc-0022-4fac-9fa6-4285d774fdb32023-12-06Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
Sildenafil CitrateSILDENAFILA-S Medication Solutionsbf1a22a2-6a69-46c9-933d-e474e88637e92023-11-24Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
ViagraSILDENAFIL CITRATEViatris Specialty LLCd905dc8d-917f-4ea3-a4ee-a1ecf6967d4e2023-11-17Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
SILDENAFILSILDENAFILAphena Pharma Solutions - Tennessee, LLCcdab7ef5-39cb-45cc-b2bf-5f634f2f54992023-11-09Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
SildenafilSILDENAFILBryant Ranch Prepack7c01fd56-5dd6-4728-9f2a-e0f5db8102692023-10-30Warnings, Adverse reactionsExact identifier
rxcui: 577033
unii: BW9B0ZE037
Sildenafil CitrateSILDENAFILProficient Rx LPb9b1d6ee-da42-4ef2-ab93-cd36d7f341502023-10-01Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
SILDENAFIL CITRATESILDENAFIL CITRATEAsclemed USA, Inc.49a95b25-08b3-4cfe-a60b-c5132c280be22023-09-13Warnings, Adverse reactionsExact identifier
application number: ANDA091479
rxcui: 577033
unii: BW9B0ZE037
Sildenafil CitrateSILDENAFIL CITRATEANI Pharmaceuticals, Inc.6d8dbaa6-d61a-46ae-a641-f664104f47142023-09-05Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
SildenafilSILDENAFILMacleods Pharmaceuticals Limitedd2892f4b-f5ba-42f5-b373-310241f4efa72023-08-11Warnings, Adverse reactionsExact identifier
rxcui: 577033
unii: BW9B0ZE037
SildenafilSILDENAFILA-S Medication Solutions997197bf-7706-4e12-97df-b0a9ea6d3a102023-07-28Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
Sildenafil CitrateSILDENAFILAsclemed USA, Inc.0500a861-359f-4e12-beb5-0cac8cd6ae1c2023-05-10Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
SILDENAFILSILDENAFILCIPLA USA INC.,15372a7c-2935-48dc-a55a-8966719b50be2023-05-02Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
RevatioSILDENAFIL CITRATEPFIZER LABORATORIES DIV PFIZER INCf158fe10-d5dc-4432-b2c9-fc665401291b2023-01-27Warnings, Adverse reactionsExact identifier
rxcui: 577033
unii: BW9B0ZE037
SildenafilSILDENAFILXLCARE Pharmaceuticals INC.ae732301-384f-43ae-80d1-5e3784fe1dca2023-01-17Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037

Reported adverse events (FAERS/openFDA)#

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