FDA.reportPublic FDA data

Vardenafil Hydrochloride

Product NDC
0527-2801
11-digit product format
005272801
Labeler code
0527
Product ID
0527-2801_0a6ac33c-4a1f-4d07-b60e-453bb7111c9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vardenafil Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA209057
Marketing category
ANDA
Marketing start
2018-11-01
Substance
VARDENAFIL HYDROCHLORIDE
Active strength
5 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
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
ndc (product): 0527-2801
Vardenafil HydrochlorideVARDENAFIL HYDROCHLORIDEAvKARE80c4793d-e19e-10f0-e053-2991aa0a46202026-01-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209057
application number: ANDA209057
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 HYDROCHLORIDE5 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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
349478Internal RxNorm lookup
349479Internal RxNorm lookup
349480Internal RxNorm lookup
402273Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2782efed-6198-47b9-81ac-3e255e2ab7f6Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0527-2801-322020-04-17C16284748780-19d75b9d0-bc62-f424-e053-dadaa90a57ceThese 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
0527-2801-322020-04-17C16284748780-19d75b9d0-bc62-f424-e053-dadaa90a57ceThese 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
0527-2801-322020-01-31C16284748780-19d75b9d0-bc62-f424-e053-dadaa90a57ceThese 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
0527-2801-322020-01-31C16284748780-19d75b9d0-bc62-f424-e053-dadaa90a57ceThese 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
0527-2801-32Vardenafil Hydrochloride30 in 1 BOTTLETABLET308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-2801-32EA - Each0527-28014250a21a-28b0-410a-af6e-d08598aac9df12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-2801VARDENAFIL HYDROCHLORIDE TABLET [LANNETT COMPANY, INC.]7Current NDC, Legacy NDC, 1 package rows20240809_2782efed-6198-47b9-81ac-3e255e2ab7f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349480vardenafil 20 MG Oral TabletPSN2782efed-6198-47b9-81ac-3e255e2ab7f68
349478vardenafil 5 MG Oral TabletPSN2782efed-6198-47b9-81ac-3e255e2ab7f68
349479vardenafil HCl 10 MG Oral TabletPSN2782efed-6198-47b9-81ac-3e255e2ab7f68
402273vardenafil HCl 2.5 MG Oral TabletPSN2782efed-6198-47b9-81ac-3e255e2ab7f68
349479vardenafil 10 MG Oral TabletSCD2782efed-6198-47b9-81ac-3e255e2ab7f68
402273vardenafil 2.5 MG Oral TabletSCD2782efed-6198-47b9-81ac-3e255e2ab7f68
349480vardenafil 20 MG Oral TabletSCD2782efed-6198-47b9-81ac-3e255e2ab7f68
349478vardenafil 5 MG Oral TabletSCD2782efed-6198-47b9-81ac-3e255e2ab7f68
349479vardenafil 10 MG (vardenafil HCl 11.85 MG) Oral TabletSY2782efed-6198-47b9-81ac-3e255e2ab7f68
402273vardenafil 2.5 MG (vardenafil hydrochloride 2.96 MG) Oral TabletSY2782efed-6198-47b9-81ac-3e255e2ab7f68
349480vardenafil 20 MG (vardenafil HCl 23.7 MG) Oral TabletSY2782efed-6198-47b9-81ac-3e255e2ab7f68
349478vardenafil 5 MG (vardenafil hydrochloride 5.926 MG) Oral TabletSY2782efed-6198-47b9-81ac-3e255e2ab7f68
349478vardenafil 5 MG Oral TabletPSN3b03952b-d404-09cd-e063-6294a90a8b2c1
349478vardenafil 5 MG Oral TabletSCD3b03952b-d404-09cd-e063-6294a90a8b2c1
349478vardenafil 5 MG (vardenafil hydrochloride 5.926 MG) Oral TabletSY3b03952b-d404-09cd-e063-6294a90a8b2c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-2801-320052728013230 TABLET in 1 BOTTLE (0527-2801-32) 30 tablet2018-11-010000-00-00NoNoCurrent