Tadalafil

Product NDC
68071-2554
11-digit product format
680712554
Labeler code
68071
Product ID
68071-2554_47f83f0a-84b5-08e6-e063-6394a90ad104
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA209654
Marketing category
ANDA
Marketing start
2019-03-26
Substance
TADALAFIL
Active strength
10 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TADALAFIL10 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
cf353da9-31c6-66c2-e053-2995a90a3bb0Available 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2554-5Tadalafil15 in 1 BOTTLETABLET155
68071-2554-6Tadalafil60 in 1 BOTTLETABLET605
68071-2554-9Tadalafil90 in 1 BOTTLETABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2554TADALAFIL TABLET [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 3 package rows20240726_cf353da9-31c6-66c2-e053-2995a90a3bb0.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
ndc (product): 68071-2554
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 TabletPSNcf353da9-31c6-66c2-e053-2995a90a3bb05
484814tadalafil 10 MG Oral TabletSCDcf353da9-31c6-66c2-e053-2995a90a3bb05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2554-56807125540515 TABLET in 1 BOTTLE (68071-2554-5) 15 tablet2021-10-250000-00-00NoNoCurrent
68071-2554-66807125540660 TABLET in 1 BOTTLE (68071-2554-6) 60 tablet2021-10-25NoNoCurrent
68071-2554-96807125540990 TABLET in 1 BOTTLE (68071-2554-9) 90 tablet2026-01-09NoNoCurrent