FDA.reportPublic FDA data

VARDENAFIL HYDROCHLORIDE

Product NDC
71335-2357
11-digit product format
713352357
Labeler code
71335
Product ID
71335-2357_d372a596-aa3a-4bd7-b311-ee32b051d758
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VARDENAFIL HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA214031
Marketing category
ANDA
Marketing start
2020-08-05
Substance
VARDENAFIL HYDROCHLORIDE
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214031-001VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2020-08-04
A214031-002VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2020-08-04
A214031-003VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2020-08-04
A214031-004VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2020-08-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214031-001AB
A214031-002AB
A214031-003AB
A214031-004AB

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 22:54:322026-06A214031-001VARDENAFIL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2020-08-04a50c72e98297…
2026-08-01 22:54:322026-06A214031-002VARDENAFIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2020-08-04a50c72e98297…
2026-08-01 22:54:322026-06A214031-003VARDENAFIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2020-08-04a50c72e98297…
2026-08-01 22:54:322026-06A214031-004VARDENAFIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2020-08-04a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A214031-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A214031-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A214031-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A214031-004AB1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEBryant Ranch Prepackd8a5cc4b-9d9d-43af-9ee4-57381aa6368a2024-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214031
application number: ANDA214031
ndc (product): 71335-2357
VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEAlembic Pharmaceuticals Inc.d2dce236-257e-44b6-93a9-9f0280257c6a2023-03-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214031
application number: ANDA214031
VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEAlembic Pharmaceuticals Limited9b8da728-8f52-4c1f-9f0c-4bd9736e912f2023-01-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214031
application number: ANDA214031

Additional Listing Data#

Finished product
Yes
Brand name base
VARDENAFIL HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VARDENAFIL HYDROCHLORIDE20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5M8S2CU0TSInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
349480Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d8a5cc4b-9d9d-43af-9ee4-57381aa6368aAvailable on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2357-1VARDENAFIL HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2357VARDENAFIL HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1Current NDC, 1 package rows20240529_d8a5cc4b-9d9d-43af-9ee4-57381aa6368a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349480vardenafil 20 MG Oral TabletPSNd8a5cc4b-9d9d-43af-9ee4-57381aa6368a1
349480vardenafil 20 MG Oral TabletSCDd8a5cc4b-9d9d-43af-9ee4-57381aa6368a1
349480vardenafil 20 MG (vardenafil HCl 23.7 MG) Oral TabletSYd8a5cc4b-9d9d-43af-9ee4-57381aa6368a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2357-17133523570130 TABLET, FILM COATED in 1 BOTTLE (71335-2357-1) 2024-05-28NoNoCurrent