FDA.reportPublic FDA data

Tadalafil

Product NDC
0378-6972
11-digit product format
003786972
Labeler code
0378
Product ID
0378-6972_364264a9-0704-496d-b7f8-df4090453cf1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA206956
Marketing category
ANDA
Marketing start
2019-05-14
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 productproduct0378-6972DDiscontinued by firm2026-07-31
excluded packagepackage0378-69720378-6972-93DDiscontinued 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206956-001TADALAFILTADALAFIL2.5MGTABLET / ORAL2019-04-29
A206956-002TADALAFILTADALAFIL10MGTABLET / ORAL2019-04-29
A206956-003TADALAFILTADALAFIL20MGTABLET / ORAL2019-04-29

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 22:54:322026-06A206956-001TADALAFIL2.5MGTABLET / ORAL2019-04-29a50c72e98297…
2026-08-01 22:54:322026-06A206956-002TADALAFIL10MGTABLET / ORAL2019-04-29a50c72e98297…
2026-08-01 22:54:322026-06A206956-003TADALAFIL20MGTABLET / ORAL2019-04-29a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-6972-93EA - Each0378-6972f43a2ccd-93e9-41f9-8b32-a01274ccd15312019-06-19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-6972-930037869729330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6972-93) 2019-05-140000-00-00NoNoCurrent