Tadalafil

Product NDC
71205-400
11-digit product format
712050400
Labeler code
71205
Product ID
71205-400_31aa3327-24b2-47cd-a16e-e0727616bc2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA210420
Marketing category
ANDA
Marketing start
2019-03-26
Marketing end
0000-00-00
Substance
TADALAFIL
Active strength
20 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71205-400DDiscontinued by firm2026-08-03
excluded packagepackage71205-40071205-400-10DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71205-400-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71205-400-10f5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A210420-001TADALAFILTADALAFIL2.5MGTABLET / ORALAB12019-03-26
A210420-002TADALAFILTADALAFIL5MGTABLET / ORALAB12019-03-26
A210420-003TADALAFILTADALAFIL10MGTABLET / ORALAB12019-03-26
A210420-004TADALAFILTADALAFIL20MGTABLET / 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
A210420-001AB1
A210420-002AB1
A210420-003AB1
A210420-004AB1

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A210420-001TADALAFIL2.5MGTABLET / ORALAB12019-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210420-002TADALAFIL5MGTABLET / ORALAB12019-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210420-003TADALAFIL10MGTABLET / ORALAB12019-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210420-004TADALAFIL20MGTABLET / ORALAB12019-03-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210420-001TADALAFIL2.5MGTABLET / ORALAB12019-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210420-002TADALAFIL5MGTABLET / ORALAB12019-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210420-003TADALAFIL10MGTABLET / ORALAB12019-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210420-004TADALAFIL20MGTABLET / ORALAB12019-03-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A210420-001TADALAFIL2.5MGTABLET / ORALAB12019-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210420-002TADALAFIL5MGTABLET / ORALAB12019-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210420-003TADALAFIL10MGTABLET / ORALAB12019-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210420-004TADALAFIL20MGTABLET / ORALAB12019-03-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210420-001TADALAFIL2.5MGTABLET / ORALAB12019-03-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210420-002TADALAFIL5MGTABLET / ORALAB12019-03-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210420-003TADALAFIL10MGTABLET / ORALAB12019-03-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210420-004TADALAFIL20MGTABLET / ORALAB12019-03-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210420-001TADALAFIL2.5MGTABLET / ORALAB12019-03-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210420-002TADALAFIL5MGTABLET / ORALAB12019-03-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210420-003TADALAFIL10MGTABLET / ORALAB12019-03-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210420-004TADALAFIL20MGTABLET / ORALAB12019-03-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210420-001TADALAFIL2.5MGTABLET / ORALAB12019-03-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210420-002TADALAFIL5MGTABLET / ORALAB12019-03-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210420-003TADALAFIL10MGTABLET / ORALAB12019-03-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210420-004TADALAFIL20MGTABLET / ORALAB12019-03-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210420-001TADALAFIL2.5MGTABLET / ORALAB12019-03-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210420-002TADALAFIL5MGTABLET / ORALAB12019-03-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210420-003TADALAFIL10MGTABLET / ORALAB12019-03-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210420-004TADALAFIL20MGTABLET / ORALAB12019-03-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210420-001TADALAFIL2.5MGTABLET / ORALAB12019-03-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210420-002TADALAFIL5MGTABLET / ORALAB12019-03-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210420-003TADALAFIL10MGTABLET / ORALAB12019-03-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210420-004TADALAFIL20MGTABLET / ORALAB12019-03-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210420-001TADALAFIL2.5MGTABLET / ORALAB12019-03-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210420-002TADALAFIL5MGTABLET / ORALAB12019-03-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210420-003TADALAFIL10MGTABLET / ORALAB12019-03-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210420-004TADALAFIL20MGTABLET / ORALAB12019-03-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210420-001TADALAFIL2.5MGTABLET / ORALAB12019-03-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A210420-002TADALAFIL5MGTABLET / ORALAB12019-03-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A210420-003TADALAFIL10MGTABLET / ORALAB12019-03-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A210420-004TADALAFIL20MGTABLET / ORALAB12019-03-26d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A210420-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210420-002AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210420-003AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210420-004AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210420-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210420-002AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210420-003AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210420-004AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210420-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210420-002AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210420-003AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210420-004AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210420-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210420-002AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210420-003AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210420-004AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210420-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210420-002AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210420-003AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210420-004AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210420-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210420-002AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210420-003AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210420-004AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210420-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210420-002AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210420-003AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210420-004AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210420-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210420-002AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210420-003AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210420-004AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210420-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210420-002AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210420-003AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210420-004AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210420-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A210420-002AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A210420-003AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A210420-004AB11d06236e962d9…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-400-10EA - Each71205-400945bda37-5f6c-40b6-ae6d-63cd37fdef9412020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-400TADALAFIL TABLET, FILM COATED [PROFICIENT RX LP]1Legacy NDC20200222_31aa3327-24b2-47cd-a16e-e0727616bc2f.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TadalafilTADALAFILUpsher-Smith Laboratories, LLCae801b15-0462-44af-99a4-affe3eed899a2026-01-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210420
application number: ANDA210420
TadalafilTADALAFILAdvanced Rx of Tennessee, LLC248a4705-1403-e94a-e063-6294a90a35442024-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210420
application number: ANDA210420
TadalafilTADALAFILQilu Pharmaceutical Co., Ltd.f295f164-78fb-4224-b319-9f20b7a453b52021-11-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210420
application number: ANDA210420

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-400-107120504001010 TABLET, FILM COATED in 1 BOTTLE (71205-400-10) 2020-02-070000-00-00NoNoCurrent