Home DailyMed 8ea14f7e-44a0-4d9c-968a-87b97ca12f09 VARDENAFIL TABLETS USP, for oral use Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer Zydus Lifesciences Limited
Effective date 2026-01-05
Label type HUMAN PRESCRIPTION DRUG LABEL
Version 7
Source full-release
Hydrated at 2026-05-31 21:54:16 Label at a glance# Product VARDENAFIL
Active ingredient VARDENAFIL HYDROCHLORIDE TRIHYDRATE
Label structure 1 sections
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY SPL version 349480 vardenafil 20 MG Oral Tablet PSN 7 349478 vardenafil 5 MG Oral Tablet PSN 7 349479 vardenafil HCl 10 MG Oral Tablet PSN 7 402273 vardenafil HCl 2.5 MG Oral Tablet PSN 7 349479 vardenafil 10 MG Oral Tablet SCD 7 402273 vardenafil 2.5 MG Oral Tablet SCD 7 349480 vardenafil 20 MG Oral Tablet SCD 7 349478 vardenafil 5 MG Oral Tablet SCD 7 349479 vardenafil 10 MG (vardenafil HCl 11.85 MG) Oral Tablet SY 7 402273 vardenafil 2.5 MG (vardenafil hydrochloride 2.96 MG) Oral Tablet SY 7 349480 vardenafil 20 MG (vardenafil HCl 23.7 MG) Oral Tablet SY 7 349478 vardenafil 5 MG (vardenafil hydrochloride 5.926 MG) Oral Tablet SY 7
DailyMed Pharmacologic Classes# DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70771-1047-1 VARDENAFIL 100 in 1 BOTTLE TABLET, FILM COATED 100 7 70771-1047-3 VARDENAFIL 30 in 1 BOTTLE TABLET, FILM COATED 30 7 70771-1047-9 VARDENAFIL 90 in 1 BOTTLE TABLET, FILM COATED 90 7 70771-1048-1 VARDENAFIL 100 in 1 BOTTLE TABLET, FILM COATED 100 7 70771-1048-3 VARDENAFIL 30 in 1 BOTTLE TABLET, FILM COATED 30 7 70771-1048-9 VARDENAFIL 90 in 1 BOTTLE TABLET, FILM COATED 90 7 70771-1049-1 VARDENAFIL 100 in 1 BOTTLE TABLET, FILM COATED 100 7 70771-1049-3 VARDENAFIL 30 in 1 BOTTLE TABLET, FILM COATED 30 7 70771-1049-9 VARDENAFIL 90 in 1 BOTTLE TABLET, FILM COATED 90 7 70771-1050-1 VARDENAFIL 100 in 1 BOTTLE TABLET, FILM COATED 100 7 70771-1050-3 VARDENAFIL 30 in 1 BOTTLE TABLET, FILM COATED 30 7 70771-1050-9 VARDENAFIL 90 in 1 BOTTLE TABLET, FILM COATED 90 7
Products# Every source-derived product name is available through these pages.
DailyMed product names page 1 of 1 · 11 matching rows.
VARDENAFIL VARDENAFIL HYDROCHLORIDE TRIHYDRATE CELLULOSE, MICROCRYSTALLINE HYPROMELLOSES POLYETHYLENE GLYCOL, UNSPECIFIED SILICON DIOXIDE SODIUM STEARYL FUMARATE STARCH, CORN TITANIUM DIOXIDE FERRIC OXIDE RED FERRIC OXIDE YELLOW Ingredients# Every source-derived ingredient row is available through these pages.
DailyMed ingredient rows page 1 of 1 · 38 matching rows.
Name, UNII, Kind table Name UNII Kind VARDENAFIL HYDROCHLORIDE TRIHYDRATE 5M8S2CU0TS ACTIM CELLULOSE, MICROCRYSTALLINE OP1R32D61U IACT HYPROMELLOSES 3NXW29V3WO IACT POLYETHYLENE GLYCOL, UNSPECIFIED 3WJQ0SDW1A IACT SILICON DIOXIDE ETJ7Z6XBU4 IACT SODIUM STEARYL FUMARATE 7CV7WJK4UI IACT STARCH, CORN O8232NY3SJ IACT TITANIUM DIOXIDE 15FIX9V2JP IACT VARDENAFIL HYDROCHLORIDE TRIHYDRATE 5M8S2CU0TS ACTIM CELLULOSE, MICROCRYSTALLINE OP1R32D61U IACT FERRIC OXIDE RED 1K09F3G675 IACT FERRIC OXIDE YELLOW EX438O2MRT IACT HYPROMELLOSES 3NXW29V3WO IACT POLYETHYLENE GLYCOL, UNSPECIFIED 3WJQ0SDW1A IACT SILICON DIOXIDE ETJ7Z6XBU4 IACT SODIUM STEARYL FUMARATE 7CV7WJK4UI IACT STARCH, CORN O8232NY3SJ IACT TITANIUM DIOXIDE 15FIX9V2JP IACT VARDENAFIL HYDROCHLORIDE TRIHYDRATE 5M8S2CU0TS ACTIM CELLULOSE, MICROCRYSTALLINE OP1R32D61U IACT FERRIC OXIDE RED 1K09F3G675 IACT FERRIC OXIDE YELLOW EX438O2MRT IACT HYPROMELLOSES 3NXW29V3WO IACT POLYETHYLENE GLYCOL, UNSPECIFIED 3WJQ0SDW1A IACT SILICON DIOXIDE ETJ7Z6XBU4 IACT SODIUM STEARYL FUMARATE 7CV7WJK4UI IACT STARCH, CORN O8232NY3SJ IACT TITANIUM DIOXIDE 15FIX9V2JP IACT VARDENAFIL HYDROCHLORIDE TRIHYDRATE 5M8S2CU0TS ACTIM CELLULOSE, MICROCRYSTALLINE OP1R32D61U IACT FERRIC OXIDE RED 1K09F3G675 IACT FERRIC OXIDE YELLOW EX438O2MRT IACT HYPROMELLOSES 3NXW29V3WO IACT POLYETHYLENE GLYCOL, UNSPECIFIED 3WJQ0SDW1A IACT SILICON DIOXIDE ETJ7Z6XBU4 IACT SODIUM STEARYL FUMARATE 7CV7WJK4UI IACT STARCH, CORN O8232NY3SJ IACT TITANIUM DIOXIDE 15FIX9V2JP IACT
Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208960-001 VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2018-10-31 A208960-002 VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2018-10-31 A208960-003 VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2018-10-31 A208960-004 VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB RS 2018-10-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 5 · 172 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A208960-001 VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2018-10-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208960-002 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2018-10-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208960-003 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2018-10-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208960-004 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB RS 2018-10-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208960-001 VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2018-10-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208960-002 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2018-10-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208960-003 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2018-10-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208960-004 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB RS 2018-10-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208960-001 VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2018-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208960-002 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2018-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208960-003 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2018-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208960-004 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB RS 2018-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208960-001 VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2018-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208960-002 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2018-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208960-003 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2018-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208960-004 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB RS 2018-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208960-001 VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2018-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208960-002 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2018-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208960-003 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2018-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208960-004 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB RS 2018-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208960-001 VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2018-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208960-002 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2018-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208960-003 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2018-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208960-004 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB RS 2018-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208960-001 VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2018-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208960-002 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2018-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208960-003 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2018-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208960-004 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB RS 2018-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208960-001 VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2018-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208960-002 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2018-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208960-003 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2018-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208960-004 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB RS 2018-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208960-001 VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2018-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208960-002 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2018-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208960-003 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2018-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208960-004 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB RS 2018-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208960-001 VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2018-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208960-002 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2018-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208960-003 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2018-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208960-004 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB RS 2018-10-31 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
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 1 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.