tadalafil

Product NDC
29300-287
11-digit product format
293000287
Labeler code
29300
Product ID
29300-287_6fee8842-9e23-43d9-a4ff-4e147bf9f6a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA209250
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 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
A209250-001TADALAFILTADALAFIL2.5MGTABLET / ORALAB12019-03-26
A209250-002TADALAFILTADALAFIL5MGTABLET / ORALAB12019-03-26
A209250-003TADALAFILTADALAFIL10MGTABLET / ORALAB12019-03-26
A209250-004TADALAFILTADALAFIL20MGTABLET / 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
A209250-001AB1
A209250-002AB1
A209250-003AB1
A209250-004AB1

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 UTC2026-02A209250-001TADALAFIL2.5MGTABLET / ORALAB12019-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209250-002TADALAFIL5MGTABLET / ORALAB12019-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209250-003TADALAFIL10MGTABLET / ORALAB12019-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209250-004TADALAFIL20MGTABLET / ORALAB12019-03-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209250-001TADALAFIL2.5MGTABLET / ORALAB12019-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209250-002TADALAFIL5MGTABLET / ORALAB12019-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209250-003TADALAFIL10MGTABLET / ORALAB12019-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209250-004TADALAFIL20MGTABLET / ORALAB12019-03-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A209250-001TADALAFIL2.5MGTABLET / ORALAB12019-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209250-002TADALAFIL5MGTABLET / ORALAB12019-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209250-003TADALAFIL10MGTABLET / ORALAB12019-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209250-004TADALAFIL20MGTABLET / ORALAB12019-03-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209250-001TADALAFIL2.5MGTABLET / ORALAB12019-03-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209250-002TADALAFIL5MGTABLET / ORALAB12019-03-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209250-003TADALAFIL10MGTABLET / ORALAB12019-03-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209250-004TADALAFIL20MGTABLET / ORALAB12019-03-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209250-001TADALAFIL2.5MGTABLET / ORALAB12019-03-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209250-002TADALAFIL5MGTABLET / ORALAB12019-03-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209250-003TADALAFIL10MGTABLET / ORALAB12019-03-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209250-004TADALAFIL20MGTABLET / ORALAB12019-03-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209250-001TADALAFIL2.5MGTABLET / ORALAB12019-03-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209250-002TADALAFIL5MGTABLET / ORALAB12019-03-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209250-003TADALAFIL10MGTABLET / ORALAB12019-03-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209250-004TADALAFIL20MGTABLET / ORALAB12019-03-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209250-001TADALAFIL2.5MGTABLET / ORALAB12019-03-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209250-002TADALAFIL5MGTABLET / ORALAB12019-03-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209250-003TADALAFIL10MGTABLET / ORALAB12019-03-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209250-004TADALAFIL20MGTABLET / ORALAB12019-03-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209250-001TADALAFIL2.5MGTABLET / ORALAB12019-03-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209250-002TADALAFIL5MGTABLET / ORALAB12019-03-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209250-003TADALAFIL10MGTABLET / ORALAB12019-03-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209250-004TADALAFIL20MGTABLET / ORALAB12019-03-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209250-001TADALAFIL2.5MGTABLET / ORALAB12019-03-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209250-002TADALAFIL5MGTABLET / ORALAB12019-03-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209250-003TADALAFIL10MGTABLET / ORALAB12019-03-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209250-004TADALAFIL20MGTABLET / ORALAB12019-03-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209250-001TADALAFIL2.5MGTABLET / ORALAB12019-03-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A209250-002TADALAFIL5MGTABLET / ORALAB12019-03-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A209250-003TADALAFIL10MGTABLET / ORALAB12019-03-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A209250-004TADALAFIL20MGTABLET / 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 UTC2026-02A209250-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209250-002AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209250-003AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209250-004AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209250-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209250-002AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209250-003AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209250-004AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209250-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209250-002AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209250-003AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209250-004AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209250-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209250-002AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209250-003AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209250-004AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209250-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209250-002AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209250-003AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209250-004AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209250-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209250-002AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209250-003AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209250-004AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209250-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209250-002AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209250-003AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209250-004AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209250-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209250-002AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209250-003AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209250-004AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209250-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209250-002AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209250-003AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209250-004AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209250-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A209250-002AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A209250-003AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A209250-004AB11d06236e962d9…

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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
402019Internal RxNorm lookup
403957Internal RxNorm lookup
484814Internal RxNorm lookup
757707Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a7b3937e-ff03-436a-a5d4-92a4771034b6Available 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
29300-287-01tadalafil100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10013
29300-287-05tadalafil500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50013
29300-287-13tadalafil30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3013
29300-287-51tadalafil15 in 1 BLISTER PACKTABLET, FILM COATED1513
29300-287-82tadalafil2 in 1 CARTONTABLET, FILM COATED213

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-287-05EA - Each29300-287826d4b5d-8ac8-45c2-b831-046eed0e410912021-08-05
29300-287-13EA - Each29300-287438f7c13-d062-44bb-875d-e0b593061b7812019-04-11
29300-287-51EA - Each29300-2877293b1ab-c249-4807-ab1c-3c602884652212019-04-11
29300-287-82EA - Each29300-287c3a3cbc7-09cc-4494-b9f7-e4f9e56a718312019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-287TADALAFIL TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]13Current NDC, Legacy NDC, 5 package rows20240201_a7b3937e-ff03-436a-a5d4-92a4771034b6.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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
tadalafilTADALAFILRedpharm Drug52505a7a-e3dd-7c4e-e063-6294a90a14732026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209250
application number: ANDA209250
tadalafilTADALAFILPreferred Pharmaceuticals Inc.fee8c2be-ccfa-4c66-abed-5e232ec762ae2026-02-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209250
application number: ANDA209250
tadalafilTADALAFILNuCare Pharmaceuticals,Inc.2c277890-3c5d-5fd5-e063-6394a90af15b2025-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209250
application number: ANDA209250
tadalafilTADALAFILAsclemed USA, Inc.fa547e3d-455a-4926-9fd9-3499308985022025-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209250
application number: ANDA209250
tadalafilTADALAFILProficient Rx LP7976c4ec-ecc4-4a49-a4fe-f990aece2d3c2025-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209250
application number: ANDA209250
tadalafilTADALAFILBryant Ranch Prepack24b82a6a-1b7e-42e6-b29b-41d4ee4d525f2025-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209250
application number: ANDA209250
tadalafilTADALAFILBryant Ranch Prepackff3c7dd3-2dcc-498c-a121-1e2aa62c7a972024-08-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209250
application number: ANDA209250
tadalafilTADALAFILProficient Rx LP929e391e-b74b-4ccd-8690-16ffcece7a302024-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209250
application number: ANDA209250
tadalafilTADALAFILNuCare Pharmaceuticals,Inc.13a107ba-cbbd-7760-e063-6394a90a1ee82024-03-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209250
application number: ANDA209250
tadalafilTADALAFILUnichem Pharmaceuticals (USA), Inc.a7b3937e-ff03-436a-a5d4-92a4771034b62024-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209250
application number: ANDA209250
ndc (product): 29300-287
tadalafilTADALAFILProficient Rx LPac93704f-8e33-43ba-8b56-3d61092ff1d92023-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209250
application number: ANDA209250

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
484814tadalafil 10 MG Oral TabletPSNa7b3937e-ff03-436a-a5d4-92a4771034b613
757707tadalafil 2.5 MG Oral TabletPSNa7b3937e-ff03-436a-a5d4-92a4771034b613
402019tadalafil 20 MG Oral TabletPSNa7b3937e-ff03-436a-a5d4-92a4771034b613
403957tadalafil 5 MG Oral TabletPSNa7b3937e-ff03-436a-a5d4-92a4771034b613
484814tadalafil 10 MG Oral TabletSCDa7b3937e-ff03-436a-a5d4-92a4771034b613
757707tadalafil 2.5 MG Oral TabletSCDa7b3937e-ff03-436a-a5d4-92a4771034b613
402019tadalafil 20 MG Oral TabletSCDa7b3937e-ff03-436a-a5d4-92a4771034b613
403957tadalafil 5 MG Oral TabletSCDa7b3937e-ff03-436a-a5d4-92a4771034b613
484814tadalafil 10 MG Oral TabletPSNfa547e3d-455a-4926-9fd9-3499308985022
757707tadalafil 2.5 MG Oral TabletPSNfa547e3d-455a-4926-9fd9-3499308985022
402019tadalafil 20 MG Oral TabletPSNfa547e3d-455a-4926-9fd9-3499308985022
403957tadalafil 5 MG Oral TabletPSNfa547e3d-455a-4926-9fd9-3499308985022
484814tadalafil 10 MG Oral TabletSCDfa547e3d-455a-4926-9fd9-3499308985022
757707tadalafil 2.5 MG Oral TabletSCDfa547e3d-455a-4926-9fd9-3499308985022
402019tadalafil 20 MG Oral TabletSCDfa547e3d-455a-4926-9fd9-3499308985022
403957tadalafil 5 MG Oral TabletSCDfa547e3d-455a-4926-9fd9-3499308985022
403957tadalafil 5 MG Oral TabletPSNff3c7dd3-2dcc-498c-a121-1e2aa62c7a971
403957tadalafil 5 MG Oral TabletPSNac93704f-8e33-43ba-8b56-3d61092ff1d91
403957tadalafil 5 MG Oral TabletPSN13a107ba-cbbd-7760-e063-6394a90a1ee81
403957tadalafil 5 MG Oral TabletSCD13a107ba-cbbd-7760-e063-6394a90a1ee81
403957tadalafil 5 MG Oral TabletSCDff3c7dd3-2dcc-498c-a121-1e2aa62c7a971
403957tadalafil 5 MG Oral TabletSCDac93704f-8e33-43ba-8b56-3d61092ff1d91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29300-287-0129300028701100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-287-01) 2019-03-260000-00-00NoNoCurrent
29300-287-0529300028705500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-287-05) 2019-03-260000-00-00NoNoCurrent
29300-287-132930002871330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-287-13) 2019-03-260000-00-00NoNoCurrent
29300-287-512930002875115 in 1 BLISTER PACKHistorical
29300-287-82293000287822 BLISTER PACK in 1 CARTON (29300-287-82) / 15 TABLET, FILM COATED in 1 BLISTER PACK (29300-287-51) 2 blister pack2019-03-260000-00-00NoNoCurrent