Home NDC 33342-154-07 Vardenafil Hydrochloride
Product NDC 33342-154
Requested package NDC 33342-154-07
11-digit product format 333420154
Labeler code 33342
Product ID 33342-154_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 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 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.
Additional Listing Data#
Finished product Yes
Brand name base Vardenafil Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VARDENAFIL 20 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 33342-154-07 Vardenafil Hydrochloride 30 in 1 BOTTLE TABLET 30 5 33342-154-11 Vardenafil Hydrochloride 100 in 1 BOTTLE TABLET 100 5 33342-154-31 Vardenafil Hydrochloride 10 in 1 BLISTER PACK TABLET 10 5 33342-154-31 Vardenafil Hydrochloride 5 in 1 CARTON TABLET 5 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-154 VARDENAFIL HYDROCHLORIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED] 5 Current NDC, Legacy NDC, 4 package rows 20230418_a38de6e1-21ca-4ebe-a3c7-6f849cf8b675.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 · 1 matching rows.
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 33342-154-07 33342015407 30 TABLET in 1 BOTTLE (33342-154-07) 30 tablet 2019-10-24 0000-00-00 No No Current