VARDENAFIL TABLETS USP, for oral use

Manufacturer
Zydus Lifesciences Limited
Effective date
2026-01-05
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 21:54:16

Label at a glance#

ProductVARDENAFIL
Active ingredientVARDENAFIL HYDROCHLORIDE TRIHYDRATE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1047-3

Vardenafil Tablets USP, 2.5 mg

30 Tablets

Rx only

Vardenafil Tablets USP, 2.5 mg
Vardenafil Tablets USP, 2.5 mg

NDC 70771-1048-3

Vardenafil Tablets USP, 5 mg

30 Tablets

Rx only

Vardenafil Tablets USP, 5 mg
Vardenafil Tablets USP, 5 mg

NDC 70771-1049-3

Vardenafil Tablets USP, 10 mg

30 Tablets

Rx only

Vardenafil Tablets USP, 10 mg
Vardenafil Tablets USP, 10 mg

NDC 70771-1050-3

Vardenafil Tablets USP, 20 mg

30 Tablets

Rx only

Vardenafil Tablets USP, 20 mg
Vardenafil Tablets USP, 20 mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
349480vardenafil 20 MG Oral TabletPSN7
349478vardenafil 5 MG Oral TabletPSN7
349479vardenafil HCl 10 MG Oral TabletPSN7
402273vardenafil HCl 2.5 MG Oral TabletPSN7
349479vardenafil 10 MG Oral TabletSCD7
402273vardenafil 2.5 MG Oral TabletSCD7
349480vardenafil 20 MG Oral TabletSCD7
349478vardenafil 5 MG Oral TabletSCD7
349479vardenafil 10 MG (vardenafil HCl 11.85 MG) Oral TabletSY7
402273vardenafil 2.5 MG (vardenafil hydrochloride 2.96 MG) Oral TabletSY7
349480vardenafil 20 MG (vardenafil HCl 23.7 MG) Oral TabletSY7
349478vardenafil 5 MG (vardenafil hydrochloride 5.926 MG) Oral TabletSY7

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
VARDENAFIL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
70771-1047-1VARDENAFIL100 in 1 BOTTLETABLET, FILM COATED1007
70771-1047-3VARDENAFIL30 in 1 BOTTLETABLET, FILM COATED307
70771-1047-9VARDENAFIL90 in 1 BOTTLETABLET, FILM COATED907
70771-1048-1VARDENAFIL100 in 1 BOTTLETABLET, FILM COATED1007
70771-1048-3VARDENAFIL30 in 1 BOTTLETABLET, FILM COATED307
70771-1048-9VARDENAFIL90 in 1 BOTTLETABLET, FILM COATED907
70771-1049-1VARDENAFIL100 in 1 BOTTLETABLET, FILM COATED1007
70771-1049-3VARDENAFIL30 in 1 BOTTLETABLET, FILM COATED307
70771-1049-9VARDENAFIL90 in 1 BOTTLETABLET, FILM COATED907
70771-1050-1VARDENAFIL100 in 1 BOTTLETABLET, FILM COATED1007
70771-1050-3VARDENAFIL30 in 1 BOTTLETABLET, FILM COATED307
70771-1050-9VARDENAFIL90 in 1 BOTTLETABLET, FILM COATED907

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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.

Product history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A208960-001VARDENAFIL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2018-10-3184e616aacf4f…
2026-09-14 22:38:342026-08A208960-002VARDENAFIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2018-10-3184e616aacf4f…
2026-09-14 22:38:342026-08A208960-003VARDENAFIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2018-10-3184e616aacf4f…
2026-09-14 22:38:342026-08A208960-004VARDENAFIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALABRS2018-10-3184e616aacf4f…
2026-08-18 06:07:402026-07A208960-001VARDENAFIL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2018-10-31caaa826d4ba7…
2026-08-18 06:07:402026-07A208960-002VARDENAFIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2018-10-31caaa826d4ba7…
2026-08-18 06:07:402026-07A208960-003VARDENAFIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2018-10-31caaa826d4ba7…
2026-08-18 06:07:402026-07A208960-004VARDENAFIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALABRS2018-10-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208960-001VARDENAFIL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2018-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208960-002VARDENAFIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2018-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208960-003VARDENAFIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2018-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208960-004VARDENAFIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALABRS2018-10-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208960-001VARDENAFIL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2018-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208960-002VARDENAFIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2018-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208960-003VARDENAFIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2018-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208960-004VARDENAFIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALABRS2018-10-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208960-001VARDENAFIL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2018-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208960-002VARDENAFIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2018-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208960-003VARDENAFIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2018-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208960-004VARDENAFIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALABRS2018-10-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208960-001VARDENAFIL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2018-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208960-002VARDENAFIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2018-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208960-003VARDENAFIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2018-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208960-004VARDENAFIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALABRS2018-10-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208960-001VARDENAFIL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2018-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208960-002VARDENAFIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2018-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208960-003VARDENAFIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2018-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208960-004VARDENAFIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALABRS2018-10-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208960-001VARDENAFIL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2018-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208960-002VARDENAFIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2018-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208960-003VARDENAFIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2018-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208960-004VARDENAFIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALABRS2018-10-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208960-001VARDENAFIL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2018-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208960-002VARDENAFIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2018-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208960-003VARDENAFIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2018-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208960-004VARDENAFIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALABRS2018-10-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208960-001VARDENAFIL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2018-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208960-002VARDENAFIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2018-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208960-003VARDENAFIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2018-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208960-004VARDENAFIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALABRS2018-10-315bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A208960-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A208960-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A208960-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A208960-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A208960-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208960-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208960-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208960-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208960-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208960-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208960-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208960-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208960-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208960-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208960-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208960-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208960-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208960-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208960-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208960-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208960-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208960-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208960-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208960-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208960-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208960-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208960-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208960-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208960-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208960-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208960-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208960-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208960-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208960-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208960-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208960-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208960-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208960-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208960-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208960-004AB15bbf6a4d5a75…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VARDENAFILVARDENAFILZydus Lifesciences Limited8ea14f7e-44a0-4d9c-968a-87b97ca12f092026-01-05Exact identifier
ndc (package): 70771-1050-3
ndc (package): 70771-1048-3
ndc (package): 70771-1048-1
ndc (package): 70771-1047-1
ndc (package): 70771-1050-9
ndc (package): 70771-1049-9
ndc (package): 70771-1049-3
ndc (package): 70771-1050-1
ndc (package): 70771-1047-9
ndc (package): 70771-1049-1
ndc (package): 70771-1048-9
ndc (package): 70771-1047-3
ndc (product): 70771-1050
ndc (product): 70771-1048
ndc (product): 70771-1047
ndc (product): 70771-1049
ndc11 (package): 70771104703
ndc11 (package): 70771104709
ndc11 (package): 70771104901
ndc11 (package): 70771104803
ndc11 (package): 70771105001
ndc11 (package): 70771104903
ndc11 (package): 70771104809
ndc11 (package): 70771104909
ndc11 (package): 70771104801
ndc11 (package): 70771105003
ndc11 (package): 70771104701
ndc11 (package): 70771105009
spl id: 4fb9ca6c-4610-42f9-87f0-224d76c542f2
spl set id: 8ea14f7e-44a0-4d9c-968a-87b97ca12f09

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.