FDA.reportPublic FDA data

Tadalafil

Product NDC
42291-789
11-digit product format
422910789
Labeler code
42291
Product ID
42291-789_c7026e67-7463-7fdc-e053-2a95a90a00d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvKARE
Application
ANDA090141
Marketing category
ANDA
Marketing start
2018-10-09
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
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42291-789DDiscontinued by firm2026-07-31
excluded packagepackage42291-78942291-789-30DDiscontinued by firm2026-07-31

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
A090141-001TADALAFILTADALAFIL2.5MGTABLET / ORALAB12018-05-22
A090141-002TADALAFILTADALAFIL5MGTABLET / ORALAB12018-05-22
A090141-003TADALAFILTADALAFIL10MGTABLET / ORALAB12018-05-22
A090141-004TADALAFILTADALAFIL20MGTABLET / ORALAB12018-05-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090141-001AB1
A090141-002AB1
A090141-003AB1
A090141-004AB1

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A090141-001TADALAFIL2.5MGTABLET / ORALAB12018-05-22a50c72e98297…
2026-08-01 22:54:322026-06A090141-002TADALAFIL5MGTABLET / ORALAB12018-05-22a50c72e98297…
2026-08-01 22:54:322026-06A090141-003TADALAFIL10MGTABLET / ORALAB12018-05-22a50c72e98297…
2026-08-01 22:54:322026-06A090141-004TADALAFIL20MGTABLET / ORALAB12018-05-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090141-001AB11a50c72e98297…
2026-08-01 22:54:322026-06A090141-002AB11a50c72e98297…
2026-08-01 22:54:322026-06A090141-003AB11a50c72e98297…
2026-08-01 22:54:322026-06A090141-004AB11a50c72e98297…

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-789-30EA - Each42291-789eb030124-317a-4e64-b9b5-b970112f647712019-05-02

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402019tadalafil 20 MG Oral TabletPSN93b97b99-1bca-4390-abad-d527128180652
403957tadalafil 5 MG Oral TabletPSN93b97b99-1bca-4390-abad-d527128180652
402019tadalafil 20 MG Oral TabletSCD93b97b99-1bca-4390-abad-d527128180652
403957tadalafil 5 MG Oral TabletSCD93b97b99-1bca-4390-abad-d527128180652

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-789-304229107893030 TABLET, FILM COATED in 1 BOTTLE (42291-789-30) 2018-10-090000-00-00NoNoCurrent