FDA.reportPublic FDA data

Vardenafil Hydrochloride

Product NDC
42291-848
11-digit product format
422910848
Labeler code
42291
Product ID
42291-848_4875c23d-91ea-f449-e063-6394a90a5a74
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vardenafil Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE
Application
ANDA209057
Marketing category
ANDA
Marketing start
2019-01-31
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
2027-12-31
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
A209057-001VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2018-10-31
A209057-002VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2018-10-31
A209057-003VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2018-10-31
A209057-004VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2018-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209057-001AB
A209057-002AB
A209057-003AB
A209057-004AB

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 22:54:322026-06A209057-001VARDENAFIL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2018-10-31a50c72e98297…
2026-08-01 22:54:322026-06A209057-002VARDENAFIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2018-10-31a50c72e98297…
2026-08-01 22:54:322026-06A209057-003VARDENAFIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2018-10-31a50c72e98297…
2026-08-01 22:54:322026-06A209057-004VARDENAFIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2018-10-31a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209057-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A209057-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A209057-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A209057-004AB1a50c72e98297…

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vardenafil HydrochlorideVARDENAFIL HYDROCHLORIDELannett Company, Inc.2782efed-6198-47b9-81ac-3e255e2ab7f62026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209057
application number: ANDA209057
Vardenafil HydrochlorideVARDENAFIL HYDROCHLORIDEAvKARE80c4793d-e19e-10f0-e053-2991aa0a46202026-01-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209057
application number: ANDA209057
ndc (product): 42291-848
Vardenafil HydrochlorideVARDENAFIL HYDROCHLORIDEChartwell RX, LLC57a0c163-a5e8-4c6e-a4ea-114cb26684072025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209057
application number: ANDA209057
Vardenafil HydrochlorideVARDENAFIL HYDROCHLORIDEBryant Ranch Prepack083a3282-254f-4042-b0eb-70f76a279f102025-11-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209057
application number: ANDA209057
Vardenafil HydrochlorideVARDENAFIL HYDROCHLORIDEBryant Ranch Prepack6d2859a7-6def-455f-856b-9db86b1fd3552025-11-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209057
application number: ANDA209057
Vardenafil HydrochlorideVARDENAFIL HYDROCHLORIDEBryant Ranch Prepack666a622b-2464-4c55-8c90-0f1cc85bc1e92025-10-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209057
application number: ANDA209057
Vardenafil HydrochlorideVARDENAFIL HYDROCHLORIDEBryant Ranch Prepack8791997d-3b86-45af-988f-808e259da5062025-10-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209057
application number: ANDA209057
Vardenafil HydrochlorideVARDENAFIL HYDROCHLORIDEAvKARE3b03952b-d404-09cd-e063-6294a90a8b2c2025-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209057
application number: ANDA209057
Vardenafil HydrochlorideVARDENAFIL HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC09366eb3-93e0-41d9-bf9a-24335ed3555f2021-01-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209057
application number: ANDA209057

Additional Listing Data#

Finished product
Yes
Brand name base
Vardenafil Hydrochloride
Listing expiration
2027-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
349479Internal RxNorm lookup
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
80c4793d-e19e-10f0-e053-2991aa0a4620Available 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
42291-848-30Vardenafil Hydrochloride30 in 1 BOTTLETABLET305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-848-30EA - Each42291-848e7c9ddf7-0ff2-4bb1-82d9-521fda65d87312019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-848VARDENAFIL HYDROCHLORIDE TABLET [AVKARE]4Current NDC, Legacy NDC, 1 package rows20240111_80c4793d-e19e-10f0-e053-2991aa0a4620.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349480vardenafil 20 MG Oral TabletPSN80c4793d-e19e-10f0-e053-2991aa0a46205
349479vardenafil HCl 10 MG Oral TabletPSN80c4793d-e19e-10f0-e053-2991aa0a46205
349479vardenafil 10 MG Oral TabletSCD80c4793d-e19e-10f0-e053-2991aa0a46205
349480vardenafil 20 MG Oral TabletSCD80c4793d-e19e-10f0-e053-2991aa0a46205
349479vardenafil 10 MG (vardenafil HCl 11.85 MG) Oral TabletSY80c4793d-e19e-10f0-e053-2991aa0a46205
349480vardenafil 20 MG (vardenafil HCl 23.7 MG) Oral TabletSY80c4793d-e19e-10f0-e053-2991aa0a46205
349480vardenafil 20 MG Oral TabletPSNd5470b59-59ff-455f-b602-36fc2839a9411
349480vardenafil 20 MG Oral TabletSCDd5470b59-59ff-455f-b602-36fc2839a9411
349480vardenafil 20 MG (vardenafil HCl 23.7 MG) Oral TabletSYd5470b59-59ff-455f-b602-36fc2839a9411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-848-304229108483030 TABLET in 1 BOTTLE (42291-848-30) 30 tablet2019-01-310000-00-00NoNoCurrent