FDA.reportPublic FDA data

Tadalafil

Product NDC
42291-788
11-digit product format
422910788
Labeler code
42291
Product ID
42291-788_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
10 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 productproduct42291-788DDiscontinued by firm2026-07-31
excluded packagepackage42291-78842291-788-30DDiscontinued 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-788-30EA - Each42291-788f2fdff97-f9a7-4930-b593-3ecc6091660e12019-05-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-788-304229107883030 TABLET, FILM COATED in 1 BOTTLE (42291-788-30) 2018-10-090000-00-00NoNoCurrent