FDA.reportPublic FDA data

Vardenafil Hydrochloride

Product NDC
33342-153
11-digit product format
333420153
Labeler code
33342
Product ID
33342-153_b02d220c-5dd4-4557-880a-7d4c0d8927b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vardenafil Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA204632
Marketing category
ANDA
Marketing start
2019-10-24
Substance
VARDENAFIL
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204632-001VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2019-10-22
A204632-002VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2019-10-22
A204632-003VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2019-10-22
A204632-004VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2019-10-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204632-001AB
A204632-002AB
A204632-003AB
A204632-004AB

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 22:54:322026-06A204632-001VARDENAFIL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2019-10-22a50c72e98297…
2026-08-01 22:54:322026-06A204632-002VARDENAFIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2019-10-22a50c72e98297…
2026-08-01 22:54:322026-06A204632-003VARDENAFIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2019-10-22a50c72e98297…
2026-08-01 22:54:322026-06A204632-004VARDENAFIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2019-10-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204632-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A204632-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A204632-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A204632-004AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vardenafil HydrochlorideVARDENAFIL HYDROCHLORIDEMacleods Pharmaceuticals Limiteda38de6e1-21ca-4ebe-a3c7-6f849cf8b6752023-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204632
application number: ANDA204632
ndc (product): 33342-153

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VARDENAFIL10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
UCE6F4125HInternal 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
a38de6e1-21ca-4ebe-a3c7-6f849cf8b675Available 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
33342-153-07Vardenafil Hydrochloride30 in 1 BOTTLETABLET305
33342-153-11Vardenafil Hydrochloride100 in 1 BOTTLETABLET1005
33342-153-12Vardenafil Hydrochloride10 in 1 CARTONTABLET105
33342-153-12Vardenafil Hydrochloride10 in 1 BLISTER PACKTABLET105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-153-07EA - Each33342-153bc9bcb64-de22-4963-9617-c361831d372812020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-153VARDENAFIL HYDROCHLORIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]5Current NDC, Legacy NDC, 4 package rows20230418_a38de6e1-21ca-4ebe-a3c7-6f849cf8b675.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349480vardenafil 20 MG Oral TabletPSNa38de6e1-21ca-4ebe-a3c7-6f849cf8b6755
349478vardenafil 5 MG Oral TabletPSNa38de6e1-21ca-4ebe-a3c7-6f849cf8b6755
349479vardenafil HCl 10 MG Oral TabletPSNa38de6e1-21ca-4ebe-a3c7-6f849cf8b6755
402273vardenafil HCl 2.5 MG Oral TabletPSNa38de6e1-21ca-4ebe-a3c7-6f849cf8b6755
349479vardenafil 10 MG Oral TabletSCDa38de6e1-21ca-4ebe-a3c7-6f849cf8b6755
402273vardenafil 2.5 MG Oral TabletSCDa38de6e1-21ca-4ebe-a3c7-6f849cf8b6755
349480vardenafil 20 MG Oral TabletSCDa38de6e1-21ca-4ebe-a3c7-6f849cf8b6755
349478vardenafil 5 MG Oral TabletSCDa38de6e1-21ca-4ebe-a3c7-6f849cf8b6755
349479vardenafil 10 MG (vardenafil HCl 11.85 MG) Oral TabletSYa38de6e1-21ca-4ebe-a3c7-6f849cf8b6755
402273vardenafil 2.5 MG (vardenafil hydrochloride 2.96 MG) Oral TabletSYa38de6e1-21ca-4ebe-a3c7-6f849cf8b6755
349480vardenafil 20 MG (vardenafil HCl 23.7 MG) Oral TabletSYa38de6e1-21ca-4ebe-a3c7-6f849cf8b6755
349478vardenafil 5 MG (vardenafil hydrochloride 5.926 MG) Oral TabletSYa38de6e1-21ca-4ebe-a3c7-6f849cf8b6755
349480vardenafil 20 MG Oral TabletPSNdb63310a-37f3-202b-e053-2995a90a55202
349478vardenafil 5 MG Oral TabletPSNdb63310a-37f3-202b-e053-2995a90a55202
349479vardenafil HCl 10 MG Oral TabletPSNdb63310a-37f3-202b-e053-2995a90a55202
402273vardenafil HCl 2.5 MG Oral TabletPSNdb63310a-37f3-202b-e053-2995a90a55202
349479vardenafil 10 MG Oral TabletSCDdb63310a-37f3-202b-e053-2995a90a55202
402273vardenafil 2.5 MG Oral TabletSCDdb63310a-37f3-202b-e053-2995a90a55202
349480vardenafil 20 MG Oral TabletSCDdb63310a-37f3-202b-e053-2995a90a55202
349478vardenafil 5 MG Oral TabletSCDdb63310a-37f3-202b-e053-2995a90a55202
349479vardenafil 10 MG (vardenafil HCl 11.85 MG) Oral TabletSYdb63310a-37f3-202b-e053-2995a90a55202
402273vardenafil 2.5 MG (vardenafil hydrochloride 2.96 MG) Oral TabletSYdb63310a-37f3-202b-e053-2995a90a55202
349480vardenafil 20 MG (vardenafil HCl 23.7 MG) Oral TabletSYdb63310a-37f3-202b-e053-2995a90a55202
349478vardenafil 5 MG (vardenafil hydrochloride 5.926 MG) Oral TabletSYdb63310a-37f3-202b-e053-2995a90a55202

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-153-073334201530730 TABLET in 1 BOTTLE (33342-153-07) 30 tablet2019-10-240000-00-00NoNoCurrent
33342-153-1133342015311100 TABLET in 1 BOTTLE (33342-153-11) 100 tablet2019-10-240000-00-00NoNoCurrent
33342-153-123334201531210 BLISTER PACK in 1 CARTON (33342-153-12) / 10 TABLET in 1 BLISTER PACK10 blister pack2019-10-240000-00-00NoNoCurrent