FDA.reportPublic FDA data

tadalafil 5 MG Oral Tablet

RxCUI
403957
RxNorm name
tadalafil 5 MG Oral Tablet
Display name
tadalafil 5 MG Oral Tablet
Full name
tadalafil 5 MG Oral Tablet
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:38:48

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 1 of 4 · 70 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TadalafilTADALAFILNorthStar Rx, LLCa10d464a-6ea7-4e5a-befa-71eceacc50392026-07-30Warnings, Adverse reactionsExact identifier
rxcui: 403957
TadalafilTADALAFILREMEDYREPACK INC.415bd983-86f3-4f38-917a-9805024f31cb2026-07-09Warnings, Adverse reactionsExact identifier
rxcui: 403957
TADALAFILTADALAFILREMEDYREPACK INC.89a33a41-0f01-4f29-8b2f-769d649fbdcb2026-06-10Warnings, Adverse reactionsExact identifier
rxcui: 403957
CialisTADALAFILEli Lilly and Companybcd8f8ab-81a2-4891-83db-24a0b0e258952026-06-03Warnings, Adverse reactionsExact identifier
rxcui: 403957
TADALAFILTADALAFILNuCare Pharmaceuticals,Inc..16f13179-7c87-aa6c-e063-6294a90a93eb2026-05-19Warnings, Adverse reactionsExact identifier
rxcui: 403957
TadalafilTADALAFILUmedica Laboratories USA Inc.6caf3b55-9bf4-4355-9e25-8bf368943fdd2026-04-26Warnings, Adverse reactionsExact identifier
rxcui: 403957
TADALAFILTADALAFILREMEDYREPACK INC.82dfea4c-9fe5-438a-917f-8f7d395ee8ca2026-04-23Warnings, Adverse reactionsExact identifier
rxcui: 403957
TadalafilTADALAFILAccord Healthcare Inc.eedf3ad9-7d40-496d-b1a9-6200010c18e12026-04-16Warnings, Adverse reactionsExact identifier
rxcui: 403957
TadalafilTADALAFILAmneal Pharmaceuticals NY LLC90f38460-62ad-492e-a3da-403d5a5a5d862026-04-15Warnings, Adverse reactionsExact identifier
rxcui: 403957
TADALAFILTADALAFILAphena Pharma Solutions - Tennessee, LLC351e28ca-3ae6-e535-e063-6394a90a9fb72026-03-23Warnings, Adverse reactionsExact identifier
rxcui: 403957
TADALAFILTADALAFILHEC Pharm USA Inc.a0f728b6-2cc6-cb65-e053-2a95a90ab1422026-03-05Warnings, Adverse reactionsExact identifier
rxcui: 403957
TADALAFILTADALAFILTorrent Pharmaceuticals Limited3ea7612b-b004-43ef-accc-34c8ec5146b82026-03-05Warnings, Adverse reactionsExact identifier
rxcui: 403957
N/ATADALAFILBostal LLC78509a43-a907-4359-9022-f38c4f7658802026-02-04Warnings, Adverse reactionsExact identifier
rxcui: 403957
TadalafilTADALAFILREMEDYREPACK INC.2121cd9b-a2c0-4f19-a33d-939c6fb3826d2026-01-20Warnings, Adverse reactionsExact identifier
rxcui: 403957
TadalafilTADALAFILAvKAREb96ae7f1-7d4a-a211-e053-2995a90ab6e22026-01-16Warnings, Adverse reactionsExact identifier
rxcui: 403957
TadalafilTADALAFILNuCare Pharmaceuticals, Inc.48892acb-43bb-a4d8-e063-6394a90a5d612026-01-16Warnings, Adverse reactionsExact identifier
rxcui: 403957
TadalafilTADALAFILUpsher-Smith Laboratories, LLCae801b15-0462-44af-99a4-affe3eed899a2026-01-16Warnings, Adverse reactionsExact identifier
rxcui: 403957
TadalafilTADALAFILNorthwind Health Company, LLCf317fe1e-d7c4-fb8b-e053-2a95a90a54452026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 403957
TadalafilTADALAFILFOURRTS (INDIA) LABORATORIES PRIVATE LIMITED0ea97208-5afc-4943-b35c-ea850203a7942025-12-19Warnings, Adverse reactionsExact identifier
rxcui: 403957
TadalafilTADALAFILNIVAGEN PHARMACEUTICALS, INC.ca1d46e3-ad9b-48c7-bb7f-63ee678ccf7a2025-12-09Warnings, Adverse reactionsExact identifier
rxcui: 403957

Reported adverse events (FAERS/openFDA)#

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

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 3 of 3 · 89 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
f9e9a953-2802-4bb1-91a3-a29be347801etadalafil 5 MG Oral Tablet [PSN] · tadalafil 5 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral use Initial U.S. Approval: 200320250829
add6afb8-d38c-47a2-8c35-d5940667bb0ctadalafil 5 MG Oral Tablet [PSN] · tadalafil 5 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral use Initial U.S. Approval: 200320241209
ff3c7dd3-2dcc-498c-a121-1e2aa62c7a97tadalafil 5 MG Oral Tablet [PSN] · tadalafil 5 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL Tablets, for oral use Initial U.S. Approval: 200320240816
b9d71483-861b-465b-846b-d7bfd6cbac11tadalafil 5 MG Oral Tablet [PSN] · tadalafil 5 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral use Initial U.S. Approval: 200320231226
ac93704f-8e33-43ba-8b56-3d61092ff1d9tadalafil 5 MG Oral Tablet [PSN] · tadalafil 5 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL Tablets, for oral use Initial U.S. Approval: 200320230101
b4d9851c-5c06-4532-bd82-16d92b60c28ftadalafil 5 MG Oral Tablet [PSN] · tadalafil 5 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral use Initial U.S. Approval: 200320211117
c4d5d1fd-65e0-70cc-e053-2995a90a5dedtadalafil 5 MG Oral Tablet [PSN] · tadalafil 5 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral use Initial U.S. Approval: 200320210615
8c687cd7-bda3-f812-e053-2995a90abfddtadalafil 5 MG Oral Tablet [PSN] · tadalafil 5 MG Oral Tablet [SCD]211225/1226/1227 TADALAFIL 5/10/20 MG20190628
a3892605-4eb1-4d6e-a675-f7f7d4302f38tadalafil 5 MG Oral Tablet [PSN] · tadalafil 5 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral use Initial U.S. Approval: 200320190326