Home NDC 33342-151 Vardenafil Hydrochloride
Product NDC 33342-151
11-digit product format 333420151
Labeler code 33342
Product ID 33342-151_b02d220c-5dd4-4557-880a-7d4c0d8927b9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Vardenafil Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA204632
Marketing category ANDA
Marketing start 2019-10-24
Substance VARDENAFIL
Active strength 2.5 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 1 .
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 A204632-001 VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2019-10-22 A204632-002 VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2019-10-22 A204632-003 VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2019-10-22 A204632-004 VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-10-22
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 4 · 156 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 2026-02-19 14:30 UTC 2026-02 A204632-001 VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2019-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204632-002 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2019-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204632-003 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2019-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204632-004 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-10-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204632-001 VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2019-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204632-002 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2019-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204632-003 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2019-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204632-004 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-10-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204632-001 VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2019-10-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204632-002 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2019-10-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204632-003 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2019-10-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204632-004 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-10-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204632-001 VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2019-10-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204632-002 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2019-10-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204632-003 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2019-10-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204632-004 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-10-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204632-001 VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2019-10-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204632-002 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2019-10-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204632-003 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2019-10-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204632-004 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-10-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204632-001 VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2019-10-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204632-002 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2019-10-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204632-003 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2019-10-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204632-004 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-10-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204632-001 VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2019-10-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204632-002 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2019-10-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204632-003 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2019-10-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204632-004 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-10-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204632-001 VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2019-10-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204632-002 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2019-10-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204632-003 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2019-10-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204632-004 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-10-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204632-001 VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2019-10-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204632-002 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2019-10-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204632-003 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2019-10-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204632-004 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-10-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204632-001 VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2019-10-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204632-002 VARDENAFIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2019-10-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204632-003 VARDENAFIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2019-10-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204632-004 VARDENAFIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2019-10-22 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 156 observed states.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Vardenafil Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VARDENAFIL 2.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination UCE6F4125H Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349478 Internal RxNorm lookup 349479 Internal RxNorm lookup 349480 Internal RxNorm lookup 402273 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 33342-151-07 Vardenafil Hydrochloride 30 in 1 BOTTLE TABLET 30 5 33342-151-11 Vardenafil Hydrochloride 100 in 1 BOTTLE TABLET 100 5 33342-151-12 Vardenafil Hydrochloride 10 in 1 CARTON TABLET 10 5 33342-151-12 Vardenafil Hydrochloride 10 in 1 BLISTER PACK TABLET 10 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-151 VARDENAFIL HYDROCHLORIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED] 5 Current NDC, Legacy NDC, 4 package rows 20230418_a38de6e1-21ca-4ebe-a3c7-6f849cf8b675.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 33342-151-07 33342015107 30 TABLET in 1 BOTTLE (33342-151-07) 30 tablet 2019-10-24 0000-00-00 No No Current 33342-151-11 33342015111 100 TABLET in 1 BOTTLE (33342-151-11) 100 tablet 2019-10-24 0000-00-00 No No Current 33342-151-12 33342015112 10 BLISTER PACK in 1 CARTON (33342-151-12) / 10 TABLET in 1 BLISTER PACK 10 blister pack 2019-10-24 0000-00-00 No No Current