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 6 of 8 · 158 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sildenafil CitrateSILDENAFIL CITRATENuCare Pharmaceuticals, Inc.20ead8ca-7cec-2d80-e063-6394a90af5482024-08-30Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
Sildenafil CitrateSILDENAFIL CITRATEMylan Pharmaceuticals Inc.98a9897b-0cbc-4ea6-9ac2-4dd719a2ede02024-08-29Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
SildenafilSILDENAFILBryant Ranch Prepackfe848310-57d8-4492-829c-3e2535754a552024-08-29Warnings, Adverse reactionsExact identifier
rxcui: 577033
unii: BW9B0ZE037
SildenafilSILDENAFILBryant Ranch Prepackf66ce83b-bad6-4180-a8c4-8475a8ec50b72024-08-21Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
SildenafilSILDENAFILBryant Ranch Prepackaf5277be-124b-4541-b6b2-bb55246cb8ed2024-08-21Warnings, Adverse reactionsExact identifier
rxcui: 577033
unii: BW9B0ZE037
SildenafilSILDENAFILTeva Pharmaceuticals USA, Inc.5cbac450-f336-45bd-8d10-9ecfd21866eb2024-07-24Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
SildenafilSILDENAFILNuCare Pharmaceuticals, Inc.46dff4c0-9a6c-20f9-e054-00144ff8d46c2024-07-16Warnings, Adverse reactionsExact identifier
rxcui: 577033
unii: BW9B0ZE037
Sildenafil CitrateSILDENAFIL CITRATEAdvanced Rx Pharmacy of Tennessee, LLCf925abbe-4977-00b0-e053-6294a90a6e532024-07-10Warnings, Adverse reactionsExact identifier
application number: ANDA091479
ndc (package): 80425-0304-3
ndc (package): 80425-0304-2
ndc (package): 80425-0304-4
ndc (package): 80425-0304-1
ndc (product): 80425-0304
ndc11 (package): 80425030401
rxcui: 577033
spl id: 1cea7dc1-3b83-0c92-e063-6394a90aec21
spl set id: f925abbe-4977-00b0-e053-6294a90a6e53
unii: BW9B0ZE037
Sildenafil CitrateSILDENAFILAdvanced Rx of Tennessee, LLC1ceb575b-2687-0456-e063-6394a90aa88a2024-07-10Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
SildenafilSILDENAFILActavis Pharma, Inc.0e6428c0-e0e9-4fc0-8615-6a9678d2286c2024-06-30Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
SildenafilSILDENAFILNuCare Pharmaceuticals,Inc.97ccea8a-6d5a-129f-e053-2995a90aa8372024-06-19Warnings, Adverse reactionsExact identifier
rxcui: 577033
unii: BW9B0ZE037
SILDENAFIL CITRATESILDENAFIL CITRATEA-S Medication Solutions6d79946b-72a9-4d1b-a84b-9d1a679a82e22024-06-18Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
SildenafilSILDENAFILAurobindo Pharma Limited363c1e77-e482-47b2-aa1e-851abd770aeb2024-06-17Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
SildenafilSILDENAFILNuCare Pharmaceuticals,Inc.72900ed9-dbab-3f7b-e053-2a91aa0a0d242024-06-12Warnings, Adverse reactionsExact identifier
rxcui: 577033
unii: BW9B0ZE037
SildenafilSILDENAFILNuCare Pharmaceuticals,Inc.78101030-ef1d-44b9-e053-2991aa0a158d2024-06-12Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
SildenafilSILDENAFILNuCare Pharmaceuticals,Inc.7925711e-2e89-fd93-e053-2991aa0a507f2024-06-12Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
SildenafilSILDENAFILNuCare Pharmaceuticals,Inc.7d68a3d3-590b-0bd9-e053-2a91aa0ae8cd2024-06-12Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
Sildenafil CitrateSILDENAFILNuCare Pharmaceuticals,Inc.0bb3eb8d-05cd-b4cd-e063-6294a90a94bb2024-05-15Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
SildenafilSILDENAFILAmneal Pharmaceuticals of New York LLCa0b734f4-9347-484d-b307-d493ae50ee542024-04-23Warnings, Adverse reactionsExact identifier
rxcui: 577033
unii: BW9B0ZE037
SildenafilSILDENAFILCamber Pharmaceuticals, Inc.f9415142-a5ac-45c0-a7c2-fb1fb6751f3d2024-04-12Warnings, Adverse reactionsExact identifier
rxcui: 577033
unii: BW9B0ZE037

Reported adverse events (FAERS/openFDA)#

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