FDA.reportPublic FDA data

TADALAFIL TABLETS

Manufacturer
Zydus Lifesciences Limited
Effective date
2024-08-12
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 21:10:25

Label at a glance#

ProductTadalafil
Active ingredientTADALAFIL
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1475-3 in bottle of 30 tablets

Tadalafil Tablets USP, 2.5 mg

Rx Only

30 tablets

2.5 mg label
2.5 mg label

NDC 70771-1476-3 in bottle of 30 tablets

Tadalafil Tablets USP, 5 mg

Rx Only

30 tablets

5 mg
5 mg

NDC 70771-1477-3 in bottle of 30 tablets

Tadalafil Tablets USP, 10 mg

Rx Only

30 tablets

10 mg
10 mg

NDC 70771-1478-3 in bottle of 30 tablets

Tadalafil Tablets USP, 20 mg

Rx Only

30 tablets

20 mg
20 mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
484814tadalafil 10 MG Oral TabletPSN4
757707tadalafil 2.5 MG Oral TabletPSN4
402019tadalafil 20 MG Oral TabletPSN4
403957tadalafil 5 MG Oral TabletPSN4
484814tadalafil 10 MG Oral TabletSCD4
757707tadalafil 2.5 MG Oral TabletSCD4
402019tadalafil 20 MG Oral TabletSCD4
403957tadalafil 5 MG Oral TabletSCD4

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b90b74cb-f6c8-3798-d11c-73b8768b278aProduct name820250317
0fe0157c-95a7-4870-ae64-de9f3fa874aeProduct name120250227
20ae0006-d78c-4dba-9e3e-6ae424841903Product name120250127
b86a08b7-54cc-440b-ad4a-3e530ccd8324Product name620230421
7a02e74a-2844-42af-84a8-96bae57351cfProduct name120230313
928d249c-35c3-4d88-a9ef-cf2f2e31b96fProduct name120220706

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1475-0Tadalafil1000 in 1 BOTTLETABLET, FILM COATED10004
70771-1475-1Tadalafil100 in 1 BOTTLETABLET, FILM COATED1004
70771-1475-3Tadalafil30 in 1 BOTTLETABLET, FILM COATED304
70771-1475-4Tadalafil2 in 1 CARTONTABLET, FILM COATED24
70771-1475-4Tadalafil15 in 1 BLISTER PACKTABLET, FILM COATED154
70771-1475-5Tadalafil500 in 1 BOTTLETABLET, FILM COATED5004
70771-1475-9Tadalafil90 in 1 BOTTLETABLET, FILM COATED904
70771-1476-0Tadalafil1000 in 1 BOTTLETABLET, FILM COATED10004
70771-1476-1Tadalafil100 in 1 BOTTLETABLET, FILM COATED1004
70771-1476-3Tadalafil30 in 1 BOTTLETABLET, FILM COATED304
70771-1476-4Tadalafil15 in 1 BLISTER PACKTABLET, FILM COATED154
70771-1476-4Tadalafil2 in 1 CARTONTABLET, FILM COATED24
70771-1476-5Tadalafil500 in 1 BOTTLETABLET, FILM COATED5004
70771-1476-7Tadalafil10 in 1 BOTTLETABLET, FILM COATED104
70771-1476-9Tadalafil90 in 1 BOTTLETABLET, FILM COATED904
70771-1477-0Tadalafil1000 in 1 BOTTLETABLET, FILM COATED10004
70771-1477-1Tadalafil100 in 1 BOTTLETABLET, FILM COATED1004
70771-1477-3Tadalafil30 in 1 BOTTLETABLET, FILM COATED304
70771-1477-4Tadalafil15 in 1 BLISTER PACKTABLET, FILM COATED154
70771-1477-4Tadalafil2 in 1 CARTONTABLET, FILM COATED24
70771-1477-5Tadalafil500 in 1 BOTTLETABLET, FILM COATED5004
70771-1477-9Tadalafil90 in 1 BOTTLETABLET, FILM COATED904
70771-1478-0Tadalafil1000 in 1 BOTTLETABLET, FILM COATED10004
70771-1478-1Tadalafil100 in 1 BOTTLETABLET, FILM COATED1004
70771-1478-3Tadalafil30 in 1 BOTTLETABLET, FILM COATED304
70771-1478-4Tadalafil2 in 1 CARTONTABLET, FILM COATED24
70771-1478-4Tadalafil15 in 1 BLISTER PACKTABLET, FILM COATED154
70771-1478-5Tadalafil500 in 1 BOTTLETABLET, FILM COATED5004
70771-1478-9Tadalafil90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1475TADALAFIL TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]4Current NDC, Legacy NDC, 7 package rows20240815_6c1c3a1f-80a4-417c-8830-5edbb9a0710f.zip
70771-1476TADALAFIL TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]4Current NDC, Legacy NDC, 8 package rows20240815_6c1c3a1f-80a4-417c-8830-5edbb9a0710f.zip
70771-1477TADALAFIL TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]4Current NDC, Legacy NDC, 7 package rows20240815_6c1c3a1f-80a4-417c-8830-5edbb9a0710f.zip
70771-1478TADALAFIL TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]4Current NDC, Legacy NDC, 7 package rows20240815_6c1c3a1f-80a4-417c-8830-5edbb9a0710f.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70771-147570771-1475-3, 70771-1475-9, 70771-1475-1, 70771-1475-5, 70771-1475-0, 70771-1475-4
70771-147670771-1476-7, 70771-1476-3, 70771-1476-9, 70771-1476-1, 70771-1476-5, 70771-1476-0, 70771-1476-4
70771-147770771-1477-3, 70771-1477-9, 70771-1477-1, 70771-1477-5, 70771-1477-0, 70771-1477-4
70771-147870771-1478-3, 70771-1478-9, 70771-1478-1, 70771-1478-5, 70771-1478-0, 70771-1478-4

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 43 matching rows.

Name, UNII, Kind table
NameUNIIKind
TADALAFIL742SXX0ICTACTIB
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
HYPROMELLOSES3NXW29V3WOIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT
TADALAFIL742SXX0ICTACTIB
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
HYPROMELLOSES3NXW29V3WOIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT
TADALAFIL742SXX0ICTACTIB
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
HYPROMELLOSES3NXW29V3WOIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT
TADALAFIL742SXX0ICTACTIB
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
HYPROMELLOSES3NXW29V3WOIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT

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 44.

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
A206693-001TADALAFILTADALAFIL2.5MGTABLET / ORALAB12019-03-26
A206693-002TADALAFILTADALAFIL5MGTABLET / ORALAB12019-03-26
A206693-003TADALAFILTADALAFIL10MGTABLET / ORALAB12019-03-26
A206693-004TADALAFILTADALAFIL20MGTABLET / ORALAB12019-03-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206693-001AB1
A206693-002AB1
A206693-003AB1
A206693-004AB1

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 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A206693-001TADALAFIL2.5MGTABLET / ORALAB12019-03-26c2088c7a36db…
2026-10-15 13:18:302026-09A206693-002TADALAFIL5MGTABLET / ORALAB12019-03-26c2088c7a36db…
2026-10-15 13:18:302026-09A206693-003TADALAFIL10MGTABLET / ORALAB12019-03-26c2088c7a36db…
2026-10-15 13:18:302026-09A206693-004TADALAFIL20MGTABLET / ORALAB12019-03-26c2088c7a36db…
2026-09-14 22:38:342026-08A206693-001TADALAFIL2.5MGTABLET / ORALAB12019-03-2684e616aacf4f…
2026-09-14 22:38:342026-08A206693-002TADALAFIL5MGTABLET / ORALAB12019-03-2684e616aacf4f…
2026-09-14 22:38:342026-08A206693-003TADALAFIL10MGTABLET / ORALAB12019-03-2684e616aacf4f…
2026-09-14 22:38:342026-08A206693-004TADALAFIL20MGTABLET / ORALAB12019-03-2684e616aacf4f…
2026-08-18 06:07:402026-07A206693-001TADALAFIL2.5MGTABLET / ORALAB12019-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07A206693-002TADALAFIL5MGTABLET / ORALAB12019-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07A206693-003TADALAFIL10MGTABLET / ORALAB12019-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07A206693-004TADALAFIL20MGTABLET / ORALAB12019-03-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206693-001TADALAFIL2.5MGTABLET / ORALAB12019-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206693-002TADALAFIL5MGTABLET / ORALAB12019-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206693-003TADALAFIL10MGTABLET / ORALAB12019-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206693-004TADALAFIL20MGTABLET / ORALAB12019-03-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206693-001TADALAFIL2.5MGTABLET / ORALAB12019-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206693-002TADALAFIL5MGTABLET / ORALAB12019-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206693-003TADALAFIL10MGTABLET / ORALAB12019-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206693-004TADALAFIL20MGTABLET / ORALAB12019-03-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A206693-001TADALAFIL2.5MGTABLET / ORALAB12019-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206693-002TADALAFIL5MGTABLET / ORALAB12019-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206693-003TADALAFIL10MGTABLET / ORALAB12019-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206693-004TADALAFIL20MGTABLET / ORALAB12019-03-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206693-001TADALAFIL2.5MGTABLET / ORALAB12019-03-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206693-002TADALAFIL5MGTABLET / ORALAB12019-03-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206693-003TADALAFIL10MGTABLET / ORALAB12019-03-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206693-004TADALAFIL20MGTABLET / ORALAB12019-03-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206693-001TADALAFIL2.5MGTABLET / ORALAB12019-03-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206693-002TADALAFIL5MGTABLET / ORALAB12019-03-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206693-003TADALAFIL10MGTABLET / ORALAB12019-03-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206693-004TADALAFIL20MGTABLET / ORALAB12019-03-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206693-001TADALAFIL2.5MGTABLET / ORALAB12019-03-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206693-002TADALAFIL5MGTABLET / ORALAB12019-03-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206693-003TADALAFIL10MGTABLET / ORALAB12019-03-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206693-004TADALAFIL20MGTABLET / ORALAB12019-03-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206693-001TADALAFIL2.5MGTABLET / ORALAB12019-03-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206693-002TADALAFIL5MGTABLET / ORALAB12019-03-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206693-003TADALAFIL10MGTABLET / ORALAB12019-03-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206693-004TADALAFIL20MGTABLET / ORALAB12019-03-262680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A206693-001AB11c2088c7a36db…
2026-10-15 13:18:302026-09A206693-002AB11c2088c7a36db…
2026-10-15 13:18:302026-09A206693-003AB11c2088c7a36db…
2026-10-15 13:18:302026-09A206693-004AB11c2088c7a36db…
2026-09-14 22:38:342026-08A206693-001AB1184e616aacf4f…
2026-09-14 22:38:342026-08A206693-002AB1184e616aacf4f…
2026-09-14 22:38:342026-08A206693-003AB1184e616aacf4f…
2026-09-14 22:38:342026-08A206693-004AB1184e616aacf4f…
2026-08-18 06:07:402026-07A206693-001AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A206693-002AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A206693-003AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A206693-004AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206693-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206693-002AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206693-003AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206693-004AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206693-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206693-002AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206693-003AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206693-004AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206693-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206693-002AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206693-003AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206693-004AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206693-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206693-002AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206693-003AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206693-004AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206693-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206693-002AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206693-003AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206693-004AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206693-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206693-002AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206693-003AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206693-004AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206693-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206693-002AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206693-003AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206693-004AB112680178bc6a6…

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
TadalafilTADALAFILZydus Lifesciences Limited6c1c3a1f-80a4-417c-8830-5edbb9a0710f2024-08-12Exact identifier
ndc (package): 70771-1478-0
ndc (package): 70771-1475-1
ndc (package): 70771-1477-0
ndc (package): 70771-1478-3
ndc (package): 70771-1475-0
ndc (package): 70771-1476-0
ndc (package): 70771-1476-4
ndc (package): 70771-1477-9
ndc (package): 70771-1478-4
ndc (package): 70771-1477-5
ndc (package): 70771-1476-1
ndc (package): 70771-1475-5
ndc (package): 70771-1477-4
ndc (package): 70771-1475-9
ndc (package): 70771-1477-3
ndc (package): 70771-1478-1
ndc (package): 70771-1475-3
ndc (package): 70771-1476-9
ndc (package): 70771-1476-3
ndc (package): 70771-1478-9
ndc (package): 70771-1477-1
ndc (package): 70771-1478-5
ndc (package): 70771-1476-7
ndc (package): 70771-1475-4
ndc (package): 70771-1476-5
ndc (product): 70771-1476
ndc (product): 70771-1475
ndc (product): 70771-1478
ndc (product): 70771-1477
ndc11 (package): 70771147603
ndc11 (package): 70771147809
ndc11 (package): 70771147703
ndc11 (package): 70771147503
ndc11 (package): 70771147501
ndc11 (package): 70771147500
ndc11 (package): 70771147605
ndc11 (package): 70771147509
ndc11 (package): 70771147803
ndc11 (package): 70771147600
ndc11 (package): 70771147704
ndc11 (package): 70771147504
ndc11 (package): 70771147601
ndc11 (package): 70771147700
ndc11 (package): 70771147804
ndc11 (package): 70771147604
ndc11 (package): 70771147607
ndc11 (package): 70771147801
ndc11 (package): 70771147709
ndc11 (package): 70771147805
ndc11 (package): 70771147800
ndc11 (package): 70771147701
ndc11 (package): 70771147609
ndc11 (package): 70771147705
ndc11 (package): 70771147505
spl id: 89266030-a1a1-4825-b9f0-9400886b6282
spl set id: 6c1c3a1f-80a4-417c-8830-5edbb9a0710f

Reported adverse events (FAERS/openFDA)#

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