FDA.reportPublic FDA data

Tadalafil

Product NDC
0093-3017
Requested package NDC
0093-3017-99
11-digit product format
000933017
Labeler code
0093
Product ID
0093-3017_08e8069b-c417-4cb8-8423-ffc540232a6a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA090141
Marketing category
ANDA
Marketing start
2018-09-27
Marketing end
0000-00-00
Substance
TADALAFIL
Active strength
5 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished packagepackage0093-30170093-3017-99UNFINISHEDActive or certified unfinished drug listing2026-07-31

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…

Additional Listing Data#

Finished product
No
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TADALAFIL5 mg/1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-3017-30EA - Each0093-301791c93d8e-815f-43f0-acee-0d68963d149112018-10-11
0093-3017-56EA - Each0093-30173aee2318-6bcc-46cb-94b4-8395af305fc212018-10-11
0093-3017-65EA - Each0093-301734913ee6-da0b-4653-93d3-a4350014a7ef12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-3017TADALAFIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]16Legacy NDC20241211_247ec8fe-e44c-4341-b992-2d6fd6d5f2ba.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startStatus
0093-3017-9900093301799241950 TABLET, FILM COATED in 1 DRUM (0093-3017-99)10-AUG-18Current