FDA.reportPublic FDA data

Vardenafil Hydrochloride

Product NDC
73750-104
Requested package NDC
73750-104-10
11-digit product format
737500104
Labeler code
73750
Product ID
73750-104_db8e52bb-02ac-9e93-e053-2a95a90a7c85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vardenafil Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
QYK BRANDS LLC
Application
ANDA204632
Marketing category
ANDA
Marketing start
2022-03-01
Marketing end
0000-00-00
Substance
VARDENAFIL
Active strength
10 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage73750-10473750-104-10IInactivated by FDA2026-08-03

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204632-001VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2019-10-22
A204632-002VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2019-10-22
A204632-003VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2019-10-22
A204632-004VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2019-10-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A204632-001AB
A204632-002AB
A204632-003AB
A204632-004AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A204632-001VARDENAFIL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2019-10-22a50c72e98297…
2026-08-01 22:54:322026-06A204632-002VARDENAFIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2019-10-22a50c72e98297…
2026-08-01 22:54:322026-06A204632-003VARDENAFIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2019-10-22a50c72e98297…
2026-08-01 22:54:322026-06A204632-004VARDENAFIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2019-10-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204632-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A204632-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A204632-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A204632-004AB1a50c72e98297…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vardenafil HydrochlorideVARDENAFIL HYDROCHLORIDEMacleods Pharmaceuticals Limiteda38de6e1-21ca-4ebe-a3c7-6f849cf8b6752023-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204632
application number: ANDA204632

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f2f15561-f1f1-39f4-fff4-873c88c535cdProduct name420210224
9c8b57d3-6030-411c-8a17-97b4b8f0ea17Product name320200708

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73750-104-102023-07-28C16284748780-10191ceaa-65ee-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use Vardenafil Hydrochloride Tablets safely and effectively. See full prescribing information for Vardenafil Hydrochloride Tablets. VARDENAFIL HYDROCHLORIDE Tablets, for oral use Initial U.S. Approval: 2003
73750-104-112023-07-28C16284748780-10191ceaa-65ee-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use Vardenafil Hydrochloride Tablets safely and effectively. See full prescribing information for Vardenafil Hydrochloride Tablets. VARDENAFIL HYDROCHLORIDE Tablets, for oral use Initial U.S. Approval: 2003
73750-104-302023-07-28C16284748780-10191ceaa-65ee-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use Vardenafil Hydrochloride Tablets safely and effectively. See full prescribing information for Vardenafil Hydrochloride Tablets. VARDENAFIL HYDROCHLORIDE Tablets, for oral use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73750-104-10Vardenafil Hydrochloride100 in 1 BOTTLETABLET1002
73750-104-11Vardenafil Hydrochloride10 in 1 BLISTER PACKTABLET102
73750-104-11Vardenafil Hydrochloride10 in 1 CARTONTABLET102
73750-104-30Vardenafil Hydrochloride30 in 1 BOTTLETABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73750-104VARDENAFIL HYDROCHLORIDE TABLET [QYK BRANDS LLC]2Legacy NDC, 4 package rows20220402_db63310a-37f3-202b-e053-2995a90a5520.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349480vardenafil 20 MG Oral TabletPSNdb63310a-37f3-202b-e053-2995a90a55202
349478vardenafil 5 MG Oral TabletPSNdb63310a-37f3-202b-e053-2995a90a55202
349479vardenafil HCl 10 MG Oral TabletPSNdb63310a-37f3-202b-e053-2995a90a55202
402273vardenafil HCl 2.5 MG Oral TabletPSNdb63310a-37f3-202b-e053-2995a90a55202
349479vardenafil 10 MG Oral TabletSCDdb63310a-37f3-202b-e053-2995a90a55202
402273vardenafil 2.5 MG Oral TabletSCDdb63310a-37f3-202b-e053-2995a90a55202
349480vardenafil 20 MG Oral TabletSCDdb63310a-37f3-202b-e053-2995a90a55202
349478vardenafil 5 MG Oral TabletSCDdb63310a-37f3-202b-e053-2995a90a55202
349479vardenafil 10 MG (vardenafil HCl 11.85 MG) Oral TabletSYdb63310a-37f3-202b-e053-2995a90a55202
402273vardenafil 2.5 MG (vardenafil hydrochloride 2.96 MG) Oral TabletSYdb63310a-37f3-202b-e053-2995a90a55202
349480vardenafil 20 MG (vardenafil HCl 23.7 MG) Oral TabletSYdb63310a-37f3-202b-e053-2995a90a55202
349478vardenafil 5 MG (vardenafil hydrochloride 5.926 MG) Oral TabletSYdb63310a-37f3-202b-e053-2995a90a55202

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73750-104-1073750010410100 TABLET in 1 BOTTLE (73750-104-10) 100 tablet2022-03-010000-00-00NoNoCurrent