Tadalafil

Product NDC
71205-734
11-digit product format
712050734
Labeler code
71205
Product ID
71205-734_a72a1311-aa68-4567-ac58-97081f675d73
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA209654
Marketing category
ANDA
Marketing start
2019-03-26
Substance
TADALAFIL
Active strength
5 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 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
A209654-001TADALAFILTADALAFIL2.5MGTABLET / ORALAB12019-03-26
A209654-002TADALAFILTADALAFIL5MGTABLET / ORALAB12019-03-26
A209654-003TADALAFILTADALAFIL10MGTABLET / ORALAB12019-03-26
A209654-004TADALAFILTADALAFIL20MGTABLET / 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
A209654-001AB1
A209654-002AB1
A209654-003AB1
A209654-004AB1

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A209654-001TADALAFIL2.5MGTABLET / ORALAB12019-03-2684e616aacf4f…
2026-09-14 22:38:342026-08A209654-002TADALAFIL5MGTABLET / ORALAB12019-03-2684e616aacf4f…
2026-09-14 22:38:342026-08A209654-003TADALAFIL10MGTABLET / ORALAB12019-03-2684e616aacf4f…
2026-09-14 22:38:342026-08A209654-004TADALAFIL20MGTABLET / ORALAB12019-03-2684e616aacf4f…
2026-08-18 06:07:402026-07A209654-001TADALAFIL2.5MGTABLET / ORALAB12019-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07A209654-002TADALAFIL5MGTABLET / ORALAB12019-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07A209654-003TADALAFIL10MGTABLET / ORALAB12019-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07A209654-004TADALAFIL20MGTABLET / ORALAB12019-03-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209654-001TADALAFIL2.5MGTABLET / ORALAB12019-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209654-002TADALAFIL5MGTABLET / ORALAB12019-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209654-003TADALAFIL10MGTABLET / ORALAB12019-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209654-004TADALAFIL20MGTABLET / ORALAB12019-03-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209654-001TADALAFIL2.5MGTABLET / ORALAB12019-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209654-002TADALAFIL5MGTABLET / ORALAB12019-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209654-003TADALAFIL10MGTABLET / ORALAB12019-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209654-004TADALAFIL20MGTABLET / ORALAB12019-03-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A209654-001TADALAFIL2.5MGTABLET / ORALAB12019-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209654-002TADALAFIL5MGTABLET / ORALAB12019-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209654-003TADALAFIL10MGTABLET / ORALAB12019-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209654-004TADALAFIL20MGTABLET / ORALAB12019-03-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209654-001TADALAFIL2.5MGTABLET / ORALAB12019-03-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209654-002TADALAFIL5MGTABLET / ORALAB12019-03-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209654-003TADALAFIL10MGTABLET / ORALAB12019-03-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209654-004TADALAFIL20MGTABLET / ORALAB12019-03-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209654-001TADALAFIL2.5MGTABLET / ORALAB12019-03-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209654-002TADALAFIL5MGTABLET / ORALAB12019-03-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209654-003TADALAFIL10MGTABLET / ORALAB12019-03-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209654-004TADALAFIL20MGTABLET / ORALAB12019-03-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209654-001TADALAFIL2.5MGTABLET / ORALAB12019-03-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209654-002TADALAFIL5MGTABLET / ORALAB12019-03-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209654-003TADALAFIL10MGTABLET / ORALAB12019-03-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209654-004TADALAFIL20MGTABLET / ORALAB12019-03-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209654-001TADALAFIL2.5MGTABLET / ORALAB12019-03-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209654-002TADALAFIL5MGTABLET / ORALAB12019-03-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209654-003TADALAFIL10MGTABLET / ORALAB12019-03-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209654-004TADALAFIL20MGTABLET / ORALAB12019-03-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209654-001TADALAFIL2.5MGTABLET / ORALAB12019-03-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209654-002TADALAFIL5MGTABLET / ORALAB12019-03-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209654-003TADALAFIL10MGTABLET / ORALAB12019-03-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209654-004TADALAFIL20MGTABLET / ORALAB12019-03-265bbf6a4d5a75…

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 22:38:342026-08A209654-001AB1184e616aacf4f…
2026-09-14 22:38:342026-08A209654-002AB1184e616aacf4f…
2026-09-14 22:38:342026-08A209654-003AB1184e616aacf4f…
2026-09-14 22:38:342026-08A209654-004AB1184e616aacf4f…
2026-08-18 06:07:402026-07A209654-001AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A209654-002AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A209654-003AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A209654-004AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209654-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209654-002AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209654-003AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209654-004AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209654-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209654-002AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209654-003AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209654-004AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209654-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209654-002AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209654-003AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209654-004AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209654-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209654-002AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209654-003AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209654-004AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209654-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209654-002AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209654-003AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209654-004AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209654-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209654-002AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209654-003AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209654-004AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209654-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209654-002AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209654-003AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209654-004AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209654-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209654-002AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209654-003AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209654-004AB115bbf6a4d5a75…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TADALAFIL5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
742SXX0ICTInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
402019Internal RxNorm lookup
403957Internal RxNorm lookup
484814Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
aa345972-40b4-415e-acb5-31b808a8d815Available on FDA.report

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
71205-734-10Tadalafil10 in 1 BOTTLETABLET102
71205-734-14Tadalafil14 in 1 BOTTLETABLET142
71205-734-15Tadalafil15 in 1 BOTTLETABLET152
71205-734-20Tadalafil20 in 1 BOTTLETABLET202
71205-734-30Tadalafil30 in 1 BOTTLETABLET302
71205-734-60Tadalafil60 in 1 BOTTLETABLET602
71205-734-90Tadalafil90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-734-30EA - Each71205-734aa9b49c9-1cb4-4067-9f62-67ac7d4ae1b312023-06-06
71205-734-90EA - Each71205-734104d9d18-952e-4112-9cc0-faf154955d0212023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-734TADALAFIL TABLET [PROFICIENT RX LP]2Current NDC, Legacy NDC, 7 package rows20230309_aa345972-40b4-415e-acb5-31b808a8d815.zip

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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TadalafilTADALAFILA-S Medication Solutionsb1840f16-a7ea-44bd-b091-5268990aedb22026-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209654
application number: ANDA209654
TadalafilTADALAFILNuCare Pharmaceuticals,Inc.c3409762-3b2b-1cfc-e053-2995a90ab91b2026-08-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209654
application number: ANDA209654
TadalafilTADALAFILNuCare Pharmaceuticals,Inc.d6e8c52f-4dc3-5d54-e053-2995a90a93582026-08-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209654
application number: ANDA209654
TadalafilTADALAFILREMEDYREPACK INC.415bd983-86f3-4f38-917a-9805024f31cb2026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209654
application number: ANDA209654
TadalafilTADALAFILREMEDYREPACK INC.ad288e9d-020a-43a0-9c07-320c5c3bbc1e2026-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209654
application number: ANDA209654
TadalafilTADALAFILBryant Ranch Prepack2c2ec257-06bc-4ca4-9cf3-d0f49980e3742026-05-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209654
application number: ANDA209654
TadalafilTADALAFILBryant Ranch Prepackc835a34a-9bae-4d88-b951-1b78ab92f3882026-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209654
application number: ANDA209654
TadalafilTADALAFILPD-Rx Pharmaceuticals, Inc.f34e4747-28be-4ae5-ac9a-a825083b6a9b2026-01-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209654
application number: ANDA209654
TadalafilTADALAFILPD-Rx Pharmaceuticals, Inc.7e236f83-14bf-4862-91fb-74d766aef6a92026-01-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209654
application number: ANDA209654
TadalafilTADALAFILNuCare Pharmaceuticals,Inc.cf353da9-31c6-66c2-e053-2995a90a3bb02026-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209654
application number: ANDA209654
TadalafilTADALAFILQuallent Pharmaceuticals Health LLCdc14daa3-cae9-4751-9034-b0e9c18054b42025-11-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209654
application number: ANDA209654
TadalafilTADALAFILAjanta Pharma USA Inc.7e4cdac1-42cc-4038-a86b-4890962ed8062025-10-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209654
application number: ANDA209654
TadalafilTADALAFILPreferred Pharmaceuticals Inc.2354c3e2-7b5f-4fdd-bbf2-7fa3c57686f82025-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209654
application number: ANDA209654
TadalafilTADALAFILPreferred Pharmaceuticals Inc.761dc0f8-2f65-4615-ab49-a4bcffd40ce92025-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209654
application number: ANDA209654
TADALAFILTADALAFILdirect rxb3ee8325-bcb2-43fd-e053-2a95a90a08c82025-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209654
application number: ANDA209654
TadalafilTADALAFILNuCare Pharmaceuticals,Inc.0a9cf85a-c17d-6890-e063-6394a90a93e92025-03-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209654
application number: ANDA209654
TadalafilTADALAFILBryant Ranch Prepack85ed0cbc-df84-44df-a9eb-f9587dbc21df2024-08-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209654
application number: ANDA209654
TadalafilTADALAFILBryant Ranch Prepack185a3284-3a4f-44d3-9278-98581d33f95b2024-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209654
application number: ANDA209654
TadalafilTADALAFILAphena Pharma Solutions - Tennessee, LLC6213fd38-9580-4253-91d2-14c28a711c202023-08-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209654
application number: ANDA209654
TadalafilTADALAFILAsclemed USA, Inc.5ea24573-2d16-40d8-a46c-7b5fa8669e692023-03-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209654
application number: ANDA209654

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
484814tadalafil 10 MG Oral TabletPSNaa345972-40b4-415e-acb5-31b808a8d8152
402019tadalafil 20 MG Oral TabletPSNaa345972-40b4-415e-acb5-31b808a8d8152
403957tadalafil 5 MG Oral TabletPSNaa345972-40b4-415e-acb5-31b808a8d8152
484814tadalafil 10 MG Oral TabletSCDaa345972-40b4-415e-acb5-31b808a8d8152
402019tadalafil 20 MG Oral TabletSCDaa345972-40b4-415e-acb5-31b808a8d8152
403957tadalafil 5 MG Oral TabletSCDaa345972-40b4-415e-acb5-31b808a8d8152

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-734-107120507341010 TABLET in 1 BOTTLE (71205-734-10) 10 tablet2023-03-03NoNoCurrent
71205-734-147120507341414 TABLET in 1 BOTTLE (71205-734-14) 14 tablet2023-03-03NoNoCurrent
71205-734-157120507341515 TABLET in 1 BOTTLE (71205-734-15) 15 tablet2023-03-03NoNoCurrent
71205-734-207120507342020 TABLET in 1 BOTTLE (71205-734-20) 20 tablet2023-03-03NoNoCurrent
71205-734-307120507343030 TABLET in 1 BOTTLE (71205-734-30) 30 tablet2022-12-230000-00-00NoNoCurrent
71205-734-607120507346060 TABLET in 1 BOTTLE (71205-734-60) 60 tablet2022-12-230000-00-00NoNoCurrent
71205-734-907120507349090 TABLET in 1 BOTTLE (71205-734-90) 90 tablet2022-12-230000-00-00NoNoCurrent