FDA.reportPublic FDA data

Vardenafil Hydrochloride

Product NDC
0093-7653
11-digit product format
000937653
Labeler code
0093
Product ID
0093-7653_51f4534a-5b11-490a-9e0b-ac681150967f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vardenafil Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA091347
Marketing category
ANDA
Marketing start
2019-01-03
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
A091347-001VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2012-05-03
A091347-002VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2012-05-03
A091347-003VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2012-05-03
A091347-004VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2012-05-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091347-001AB
A091347-002AB
A091347-003AB
A091347-004AB

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 22:54:322026-06A091347-001VARDENAFIL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2012-05-03a50c72e98297…
2026-08-01 22:54:322026-06A091347-002VARDENAFIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2012-05-03a50c72e98297…
2026-08-01 22:54:322026-06A091347-003VARDENAFIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2012-05-03a50c72e98297…
2026-08-01 22:54:322026-06A091347-004VARDENAFIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2012-05-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A091347-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A091347-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A091347-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A091347-004AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vardenafil HydrochlorideVARDENAFIL HYDROCHLORIDEBryant Ranch Prepack31be68b0-ac7e-42d0-9435-1f0a329b63d82024-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091347
application number: ANDA091347
Vardenafil HydrochlorideVARDENAFIL HYDROCHLORIDETeva Pharmaceuticals USA, Inc.e593ab58-70a4-4095-8091-16a4b6d49e4d2023-12-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091347
application number: ANDA091347
ndc (product): 0093-7653

Additional Listing Data#

Finished product
Yes
Brand name base
Vardenafil Hydrochloride
Listing expiration
2026-12-31

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
e593ab58-70a4-4095-8091-16a4b6d49e4dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f2f15561-f1f1-39f4-fff4-873c88c535cdProduct name420210224
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
9c8b57d3-6030-411c-8a17-97b4b8f0ea17Product name320200708

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-7653-56Vardenafil Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7653-56EA - Each0093-7653b2323fc0-8d27-46c9-a41d-b1854b18918612019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-7653VARDENAFIL HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]11Current NDC, Legacy NDC, 1 package rows20240125_e593ab58-70a4-4095-8091-16a4b6d49e4d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349480vardenafil 20 MG Oral TabletPSNe593ab58-70a4-4095-8091-16a4b6d49e4d11
349478vardenafil 5 MG Oral TabletPSNe593ab58-70a4-4095-8091-16a4b6d49e4d11
349479vardenafil HCl 10 MG Oral TabletPSNe593ab58-70a4-4095-8091-16a4b6d49e4d11
402273vardenafil HCl 2.5 MG Oral TabletPSNe593ab58-70a4-4095-8091-16a4b6d49e4d11
349479vardenafil 10 MG Oral TabletSCDe593ab58-70a4-4095-8091-16a4b6d49e4d11
402273vardenafil 2.5 MG Oral TabletSCDe593ab58-70a4-4095-8091-16a4b6d49e4d11
349480vardenafil 20 MG Oral TabletSCDe593ab58-70a4-4095-8091-16a4b6d49e4d11
349478vardenafil 5 MG Oral TabletSCDe593ab58-70a4-4095-8091-16a4b6d49e4d11
349479vardenafil 10 MG (vardenafil HCl 11.85 MG) Oral TabletSYe593ab58-70a4-4095-8091-16a4b6d49e4d11
402273vardenafil 2.5 MG (vardenafil hydrochloride 2.96 MG) Oral TabletSYe593ab58-70a4-4095-8091-16a4b6d49e4d11
349480vardenafil 20 MG (vardenafil HCl 23.7 MG) Oral TabletSYe593ab58-70a4-4095-8091-16a4b6d49e4d11
349478vardenafil 5 MG (vardenafil hydrochloride 5.926 MG) Oral TabletSYe593ab58-70a4-4095-8091-16a4b6d49e4d11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-7653-560009376535630 TABLET, FILM COATED in 1 BOTTLE (0093-7653-56) 2019-01-030000-00-00NoNoCurrent