Home NDC 71335-9688 Vardenafil Hydrochloride
Product NDC 71335-9688
11-digit product format 713359688
Labeler code 71335
Product ID 71335-9688_5b030c96-c5e2-4cde-abda-d6eedff4169d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Vardenafil Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA091347
Marketing category ANDA
Marketing start 2019-01-03
Substance VARDENAFIL HYDROCHLORIDE
Active strength 20 mg/1
Pharmacologic classes Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A091347-001 VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2012-05-03 A091347-002 VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2012-05-03 A091347-003 VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2012-05-03 A091347-004 VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2012-05-03
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 · 168 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 2026-08-18 06:07:40 2026-07 A091347-001 VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2012-05-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091347-002 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2012-05-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091347-003 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2012-05-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091347-004 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2012-05-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091347-001 VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2012-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091347-002 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2012-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091347-003 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2012-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091347-004 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2012-05-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091347-001 VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2012-05-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091347-002 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2012-05-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091347-003 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2012-05-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091347-004 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2012-05-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091347-001 VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2012-05-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091347-002 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2012-05-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091347-003 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2012-05-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091347-004 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2012-05-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091347-001 VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2012-05-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091347-002 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2012-05-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091347-003 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2012-05-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091347-004 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2012-05-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091347-001 VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2012-05-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091347-002 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2012-05-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091347-003 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2012-05-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091347-004 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2012-05-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091347-001 VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2012-05-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091347-002 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2012-05-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091347-003 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2012-05-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091347-004 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2012-05-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091347-001 VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2012-05-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091347-002 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2012-05-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091347-003 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2012-05-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091347-004 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2012-05-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091347-001 VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2012-05-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091347-002 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2012-05-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091347-003 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2012-05-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091347-004 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2012-05-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091347-001 VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2012-05-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091347-002 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2012-05-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091347-003 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2012-05-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091347-004 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2012-05-03 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 168 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Vardenafil Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VARDENAFIL HYDROCHLORIDE 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5M8S2CU0TS Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349480 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71335-9688-1 Vardenafil Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 101
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-9688 VARDENAFIL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] 101 Current NDC, 1 package rows 20240406_31be68b0-ac7e-42d0-9435-1f0a329b63d8.zip
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 71335-9688-1 71335968801 30 TABLET, FILM COATED in 1 BOTTLE (71335-9688-1) 2024-04-03 No No Current