Home NDC 33342-203 Vardenafil
Product NDC 33342-203
11-digit product format 333420203
Labeler code 33342
Product ID 33342-203_695d5a7e-546f-4e86-8edc-3c32e1d3bb19
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Vardenafil
Dosage form TABLET
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA205988
Marketing category ANDA
Marketing start 2018-10-26
Substance VARDENAFIL HYDROCHLORIDE TRIHYDRATE
Active strength 11.85 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A205988-001 VARDENAFIL HYDROCHLORIDE VARDENAFIL HYDROCHLORIDE 10MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2020-03-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205988-001 AB
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.
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 2026-08-01 22:54:32 2026-06 A205988-001 VARDENAFIL HYDROCHLORIDE 10MG TABLET, ORALLY DISINTEGRATING / ORAL AB 2020-03-10 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A205988-001 AB 1 a50c72e98297…
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
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VARDENAFIL HYDROCHLORIDE TRIHYDRATE 11.85 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 996179 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 33342-203-37 Vardenafil 1 in 1 CARTON TABLET 1 6 33342-203-37 Vardenafil 4 in 1 BLISTER PACK TABLET 4 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-203 VARDENAFIL TABLET [MACLEODS PHARMACEUTICALS LIMITED] 6 Current NDC, Legacy NDC, 2 package rows 20250201_0ad213e0-d18a-4e67-a405-df95322eaa52.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 33342-203-37 33342020337 1 BLISTER PACK in 1 CARTON (33342-203-37) / 4 TABLET in 1 BLISTER PACK 1 blister pack 2018-10-26 0000-00-00 No No Current