TADALAFIL

Product NDC
71610-908
11-digit product format
716100908
Labeler code
71610
Product ID
71610-908_35a64ceb-88bf-d4ed-e063-6394a90a7799
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tadalafil
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA210609
Marketing category
ANDA
Marketing start
2024-11-27
Substance
TADALAFIL
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 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
A210609-001TADALAFILTADALAFIL2.5MGTABLET / ORALAB12022-08-11
A210609-002TADALAFILTADALAFIL5MGTABLET / ORALAB12022-08-11
A210609-003TADALAFILTADALAFIL10MGTABLET / ORALAB12022-08-11
A210609-004TADALAFILTADALAFIL20MGTABLET / ORALAB12022-08-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210609-001AB1
A210609-002AB1
A210609-003AB1
A210609-004AB1

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 3 · 116 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A210609-001TADALAFIL2.5MGTABLET / ORALAB12022-08-1184e616aacf4f…
2026-09-14 22:38:342026-08A210609-002TADALAFIL5MGTABLET / ORALAB12022-08-1184e616aacf4f…
2026-09-14 22:38:342026-08A210609-003TADALAFIL10MGTABLET / ORALAB12022-08-1184e616aacf4f…
2026-09-14 22:38:342026-08A210609-004TADALAFIL20MGTABLET / ORALAB12022-08-1184e616aacf4f…
2026-08-18 06:07:402026-07A210609-001TADALAFIL2.5MGTABLET / ORALAB12022-08-11caaa826d4ba7…
2026-08-18 06:07:402026-07A210609-002TADALAFIL5MGTABLET / ORALAB12022-08-11caaa826d4ba7…
2026-08-18 06:07:402026-07A210609-003TADALAFIL10MGTABLET / ORALAB12022-08-11caaa826d4ba7…
2026-08-18 06:07:402026-07A210609-004TADALAFIL20MGTABLET / ORALAB12022-08-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210609-001TADALAFIL2.5MGTABLET / ORALAB12022-08-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210609-002TADALAFIL5MGTABLET / ORALAB12022-08-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210609-003TADALAFIL10MGTABLET / ORALAB12022-08-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210609-004TADALAFIL20MGTABLET / ORALAB12022-08-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210609-001TADALAFIL2.5MGTABLET / ORALAB12022-08-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210609-002TADALAFIL5MGTABLET / ORALAB12022-08-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210609-003TADALAFIL10MGTABLET / ORALAB12022-08-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210609-004TADALAFIL20MGTABLET / ORALAB12022-08-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210609-001TADALAFIL2.5MGTABLET / ORALAB12022-08-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210609-002TADALAFIL5MGTABLET / ORALAB12022-08-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210609-003TADALAFIL10MGTABLET / ORALAB12022-08-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210609-004TADALAFIL20MGTABLET / ORALAB12022-08-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210609-001TADALAFIL2.5MGTABLET / ORALAB12022-08-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210609-002TADALAFIL5MGTABLET / ORALAB12022-08-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210609-003TADALAFIL10MGTABLET / ORALAB12022-08-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210609-004TADALAFIL20MGTABLET / ORALAB12022-08-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210609-001TADALAFIL2.5MGTABLET / ORALAB12022-08-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210609-002TADALAFIL5MGTABLET / ORALAB12022-08-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210609-003TADALAFIL10MGTABLET / ORALAB12022-08-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210609-004TADALAFIL20MGTABLET / ORALAB12022-08-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210609-001TADALAFIL2.5MGTABLET / ORALAB12022-08-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210609-002TADALAFIL5MGTABLET / ORALAB12022-08-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210609-003TADALAFIL10MGTABLET / ORALAB12022-08-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210609-004TADALAFIL20MGTABLET / ORALAB12022-08-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210609-001TADALAFIL2.5MGTABLET / ORALAB12022-08-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210609-002TADALAFIL5MGTABLET / ORALAB12022-08-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210609-003TADALAFIL10MGTABLET / ORALAB12022-08-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210609-004TADALAFIL20MGTABLET / ORALAB12022-08-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210609-001TADALAFIL2.5MGTABLET / ORALAB12022-08-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210609-002TADALAFIL5MGTABLET / ORALAB12022-08-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210609-003TADALAFIL10MGTABLET / ORALAB12022-08-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210609-004TADALAFIL20MGTABLET / ORALAB12022-08-115bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 116 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A210609-001AB1184e616aacf4f…
2026-09-14 22:38:342026-08A210609-002AB1184e616aacf4f…
2026-09-14 22:38:342026-08A210609-003AB1184e616aacf4f…
2026-09-14 22:38:342026-08A210609-004AB1184e616aacf4f…
2026-08-18 06:07:402026-07A210609-001AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A210609-002AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A210609-003AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A210609-004AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210609-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210609-002AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210609-003AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210609-004AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210609-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210609-002AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210609-003AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210609-004AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210609-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210609-002AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210609-003AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210609-004AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210609-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210609-002AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210609-003AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210609-004AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210609-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210609-002AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210609-003AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210609-004AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210609-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210609-002AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210609-003AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210609-004AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210609-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210609-002AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210609-003AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210609-004AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210609-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210609-002AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210609-003AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210609-004AB115bbf6a4d5a75…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

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
351de7c2-98bf-7c88-e063-6294a90ad811Available 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b86a08b7-54cc-440b-ad4a-3e530ccd8324Product name620230421
7a02e74a-2844-42af-84a8-96bae57351cfProduct name120230313
928d249c-35c3-4d88-a9ef-cf2f2e31b96fProduct name120220706
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-908-04TADALAFIL4 in 1 BOTTLETABLET42
71610-908-06TADALAFIL6 in 1 BOTTLETABLET62
71610-908-12TADALAFIL12 in 1 BOTTLETABLET122
71610-908-39TADALAFIL1440 in 1 BOTTLETABLET14402
71610-908-52TADALAFIL18 in 1 BOTTLETABLET182

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-908-04EA - Each71610-9089923484a-2145-49bb-bbd8-bacdca3cd59812025-06-13
71610-908-06EA - Each71610-908ed70b87b-258b-4cee-9050-aa632afcd80f12025-06-13
71610-908-12EA - Each71610-908811619e1-488d-4ea2-9ccc-4d70b82e40da12025-06-13
71610-908-39EA - Each71610-908d02b4398-71da-4ce8-93af-0ffbec3d39a512025-06-13
71610-908-52EA - Each71610-908f991769b-84fc-4614-8580-93a3ada35da412025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-908TADALAFIL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]2Current NDC, 5 package rows20250523_351de7c2-98bf-7c88-e063-6294a90ad811.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 1 · 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TADALAFILTADALAFILREMEDYREPACK INC.89a33a41-0f01-4f29-8b2f-769d649fbdcb2026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210609
application number: ANDA210609
TADALAFILTADALAFILBryant Ranch Prepackb3a58c17-f260-4125-abd1-27da00bb07192026-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210609
application number: ANDA210609
TADALAFILTADALAFILNuCare Pharmaceuticals,Inc..16f13179-7c87-aa6c-e063-6294a90a93eb2026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210609
application number: ANDA210609
TADALAFILTADALAFILAphena Pharma Solutions - Tennessee, LLC351e28ca-3ae6-e535-e063-6394a90a9fb72026-03-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210609
application number: ANDA210609
TADALAFILTADALAFILA-S Medication Solutionscd94158b-43fa-44fc-a858-0983770efa832026-02-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210609
application number: ANDA210609
TADALAFILTADALAFILPreferred Pharmaceuticals Inc.66e24ced-0008-40cb-b242-9d9add1f665c2025-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210609
application number: ANDA210609
TADALAFILTADALAFILPreferred Pharmaceuticals Inc.09ad27a1-3908-4533-b84c-7a7fd35141012025-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210609
application number: ANDA210609
TADALAFILTADALAFILSolco Healthcare US, LLC05640a4d-afb7-42ae-a5bb-77dbc84123562025-08-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210609
application number: ANDA210609
TADALAFILTADALAFILNuCare Pharmaceuticals, Inc.2c4108c6-9014-4bd8-e063-6294a90a88fa2025-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210609
application number: ANDA210609
TADALAFILTADALAFILBryant Ranch Prepack716c586d-e524-4f3e-ab1d-7ef9184169d92025-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210609
application number: ANDA210609
TADALAFILTADALAFILAphena Pharma Solutions - Tennessee, LLC351de7c2-98bf-7c88-e063-6294a90ad8112025-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210609
application number: ANDA210609
ndc (product): 71610-908
TADALAFILTADALAFILAphena Pharma Solutions - Tennessee, LLC34684fe8-9bf3-47fd-e063-6394a90ac80f2025-05-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210609
application number: ANDA210609
TADALAFILTADALAFILSolco Healthcare US, LLC491cb72b-71f2-4df9-99f8-c02d935001032025-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210609
application number: ANDA210609
TADALAFILTADALAFILNuCare Pharmaceuticals, Inc.2eae8756-5c7f-2545-e063-6294a90a6d522025-02-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210609
application number: ANDA210609
TADALAFILTADALAFILNuCare Pharmaceuticals,Inc.0b75f746-866e-3a5b-e063-6294a90a5e022025-01-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210609
application number: ANDA210609
TADALAFILTADALAFILNuCare Pharmaceuticals, Inc.2ad52dff-9fcd-041f-e063-6394a90afcef2025-01-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210609
application number: ANDA210609
TADALAFILTADALAFILNuCare Pharmaceuticals,Inc.2a4666e1-4151-f540-e063-6394a90aed0b2024-12-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210609
application number: ANDA210609
TADALAFILTADALAFILNuCare Pharmaceuticals,Inc.17947ccd-6f0e-d4cd-e063-6294a90a108a2024-05-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210609
application number: ANDA210609

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
484814tadalafil 10 MG Oral TabletPSN351de7c2-98bf-7c88-e063-6294a90ad8112
484814tadalafil 10 MG Oral TabletSCD351de7c2-98bf-7c88-e063-6294a90ad8112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-908-04716100908044 TABLET in 1 BOTTLE (71610-908-04) 4 tablet2025-05-16NoNoCurrent
71610-908-06716100908066 TABLET in 1 BOTTLE (71610-908-06) 6 tablet2025-05-16NoNoCurrent
71610-908-127161009081212 TABLET in 1 BOTTLE (71610-908-12) 12 tablet2025-05-16NoNoCurrent
71610-908-39716100908391440 TABLET in 1 BOTTLE (71610-908-39) 1440 tablet2025-05-13NoNoCurrent
71610-908-527161009085218 TABLET in 1 BOTTLE (71610-908-52) 18 tablet2025-05-16NoNoCurrent