FDA.reportPublic FDA data

VARDENAFIL

Product NDC
70710-1068
11-digit product format
707101068
Labeler code
70710
Product ID
70710-1068_a6417d62-c65a-49a5-a3c7-d9d178a36cb9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VARDENAFIL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA208960
Marketing category
ANDA
Marketing start
2018-11-01
Substance
VARDENAFIL HYDROCHLORIDE TRIHYDRATE
Active strength
2.5 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
A208960-001VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2018-10-31
A208960-002VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2018-10-31
A208960-003VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2018-10-31
A208960-004VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALABRS2018-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208960-001AB
A208960-002AB
A208960-003AB
A208960-004AB

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 22:54:322026-06A208960-001VARDENAFIL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2018-10-31a50c72e98297…
2026-08-01 22:54:322026-06A208960-002VARDENAFIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2018-10-31a50c72e98297…
2026-08-01 22:54:322026-06A208960-003VARDENAFIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2018-10-31a50c72e98297…
2026-08-01 22:54:322026-06A208960-004VARDENAFIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALABRS2018-10-31a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A208960-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A208960-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A208960-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A208960-004AB1a50c72e98297…

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
VARDENAFILVARDENAFILZydus Lifesciences Limited8ea14f7e-44a0-4d9c-968a-87b97ca12f092026-01-05Exact identifier
application applno (ANDA): 208960
application number: ANDA208960
VARDENAFILVARDENAFILZydus Pharmaceuticals USA Inc.5876e062-e604-42a7-99c3-5da30b8dac062026-01-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208960
application number: ANDA208960
ndc (product): 70710-1068
VARDENAFILVARDENAFILAphena Pharma Solutions - Tennessee, LLCc70a9c8e-46b0-489d-bbda-2d7fca4b629f2020-11-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208960
application number: ANDA208960

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VARDENAFIL HYDROCHLORIDE TRIHYDRATE2.5 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
5876e062-e604-42a7-99c3-5da30b8dac06Available 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
70710-1068-1VARDENAFIL100 in 1 BOTTLETABLET, FILM COATED1006
70710-1068-3VARDENAFIL30 in 1 BOTTLETABLET, FILM COATED306
70710-1068-9VARDENAFIL90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1068-3EA - Each70710-1068e3030ed9-4d8b-463a-bccc-e0ff37257fb112018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1068VARDENAFIL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.]5Current NDC, Legacy NDC, 3 package rows20230613_5876e062-e604-42a7-99c3-5da30b8dac06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349480vardenafil 20 MG Oral TabletPSN5876e062-e604-42a7-99c3-5da30b8dac066
349478vardenafil 5 MG Oral TabletPSN5876e062-e604-42a7-99c3-5da30b8dac066
349479vardenafil HCl 10 MG Oral TabletPSN5876e062-e604-42a7-99c3-5da30b8dac066
402273vardenafil HCl 2.5 MG Oral TabletPSN5876e062-e604-42a7-99c3-5da30b8dac066
349479vardenafil 10 MG Oral TabletSCD5876e062-e604-42a7-99c3-5da30b8dac066
402273vardenafil 2.5 MG Oral TabletSCD5876e062-e604-42a7-99c3-5da30b8dac066
349480vardenafil 20 MG Oral TabletSCD5876e062-e604-42a7-99c3-5da30b8dac066
349478vardenafil 5 MG Oral TabletSCD5876e062-e604-42a7-99c3-5da30b8dac066
349479vardenafil 10 MG (vardenafil HCl 11.85 MG) Oral TabletSY5876e062-e604-42a7-99c3-5da30b8dac066
402273vardenafil 2.5 MG (vardenafil hydrochloride 2.96 MG) Oral TabletSY5876e062-e604-42a7-99c3-5da30b8dac066
349480vardenafil 20 MG (vardenafil HCl 23.7 MG) Oral TabletSY5876e062-e604-42a7-99c3-5da30b8dac066
349478vardenafil 5 MG (vardenafil hydrochloride 5.926 MG) Oral TabletSY5876e062-e604-42a7-99c3-5da30b8dac066

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70710-1068-170710106801100 TABLET, FILM COATED in 1 BOTTLE (70710-1068-1) 2018-11-010000-00-00NoNoCurrent
70710-1068-37071010680330 TABLET, FILM COATED in 1 BOTTLE (70710-1068-3) 2018-11-010000-00-00NoNoCurrent
70710-1068-97071010680990 TABLET, FILM COATED in 1 BOTTLE (70710-1068-9) 2018-11-010000-00-00NoNoCurrent