Home NDC 43353-323 Levitra
Product NDC 43353-323
11-digit product format 433530323
Labeler code 43353
Product ID 43353-323_741bda18-742a-4192-b37c-41680ca38343
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name vardenafil hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler APHENA PHARMA SOLUTIONS - TENNESSEE, INC.
Application NDA021400
Marketing category NDA
Marketing start 2008-05-15
Marketing end 0000-00-00
Substance VARDENAFIL HYDROCHLORIDE
Active strength 5 mg/1
Pharmacologic classes Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record 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 N021400-001 LEVITRA VARDENAFIL HYDROCHLORIDE EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-08-19 N021400-002 LEVITRA VARDENAFIL HYDROCHLORIDE EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-08-19 N021400-003 LEVITRA VARDENAFIL HYDROCHLORIDE EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-08-19 N021400-004 LEVITRA VARDENAFIL HYDROCHLORIDE EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-08-19
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021400-001 8273876 2027-07-23 U-1288 2012-10-24 N021400-002 8273876 2027-07-23 U-1288 N021400-003 8273876 2027-07-23 U-1288 N021400-004 8273876 2027-07-23 U-1288
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 N021400-001 LEVITRA EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-08-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N021400-002 LEVITRA EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-08-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N021400-003 LEVITRA EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-08-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N021400-004 LEVITRA EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-08-19 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N021400-001 8273876 2027-07-23 U-1288 2012-10-24 a50c72e98297…2026-08-01 22:54:32 2026-06 N021400-002 8273876 2027-07-23 U-1288 a50c72e98297…2026-08-01 22:54:32 2026-06 N021400-003 8273876 2027-07-23 U-1288 a50c72e98297…2026-08-01 22:54:32 2026-06 N021400-004 8273876 2027-07-23 U-1288 a50c72e98297…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43353-323-02 Levitra 2 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 2 1 43353-323-06 Levitra 6 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 6 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded VARDENAFIL HYDROCHLORIDE ACTIVE INGREDIENT 5M8S2CU0TS LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 VARDENAFIL ACTIVE MOIETY UCE6F4125H LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-323 LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 Legacy NDC, 2 package rows 20111027_be38b325-3a6f-4569-9ae0-a03feff8535d.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 43353-323-02 43353032302 2 in 1 BOTTLE, PLASTIC Historical 43353-323-06 43353032306 6 in 1 BOTTLE, PLASTIC Historical