FDA.reportPublic FDA data

Vardenafil

Product NDC
62332-235
11-digit product format
623320235
Labeler code
62332
Product ID
62332-235_33bb2a69-79e4-49bb-9388-97367b428639
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vardenafil
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA208324
Marketing category
ANDA
Marketing start
2018-11-20
Substance
VARDENAFIL HYDROCHLORIDE TRIHYDRATE
Active strength
10 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208324-001VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORALABRS2018-11-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208324-001AB

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 22:54:322026-06A208324-001VARDENAFIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORALABRS2018-11-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A208324-001AB1a50c72e98297…

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
VardenafilVARDENAFILAlembic Pharmaceuticals Inc.0ce4eb7b-fa50-441d-ae71-eb33dca279262025-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208324
application number: ANDA208324
ndc (product): 62332-235
VardenafilVARDENAFILAlembic Pharmaceuticals Limiteddce0b31b-4522-4cb4-9dba-3aea2b2bb0822023-01-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208324
application number: ANDA208324

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VARDENAFIL HYDROCHLORIDE TRIHYDRATE10 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
996179Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0ce4eb7b-fa50-441d-ae71-eb33dca27926Available 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
62332-235-04Vardenafil4 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING412
62332-235-04Vardenafil4 in 1 CARTONTABLET, ORALLY DISINTEGRATING412

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-235-04EA - Each62332-235b2f8dbd8-b355-423e-9cb1-08ef613fc7a212018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-235VARDENAFIL TABLET, ORALLY DISINTEGRATING [ALEMBIC PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 2 package rows20231024_0ce4eb7b-fa50-441d-ae71-eb33dca27926.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996179vardenafil 10 MG Disintegrating Oral TabletPSN0ce4eb7b-fa50-441d-ae71-eb33dca2792612
996179vardenafil 10 MG Disintegrating Oral TabletSCD0ce4eb7b-fa50-441d-ae71-eb33dca2792612
996179vardenafil 10 MG (vardenafil HCl 11.85 MG) Disintegrating Oral TabletSY0ce4eb7b-fa50-441d-ae71-eb33dca2792612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-235-04623320235044 BLISTER PACK in 1 CARTON (62332-235-04) / 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK4 blister pack2018-11-200000-00-00NoNoCurrent