FDA.reportPublic FDA data

Tadalafil

Product NDC
0378-6970
Requested package NDC
0378-6970-85
11-digit product format
003786970
Labeler code
0378
Product ID
0378-6970_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
3 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0378-69700378-6970-85DDiscontinued 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
0378-6970-32EA - Each0378-6970443ce756-d487-420b-899d-2e4806c80a0a12019-06-19
0378-6970-85EA - Each0378-69702a9cad16-8893-49d0-884d-a021c873ac9f12019-06-19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-6970-85003786970852 BLISTER PACK in 1 CARTON (0378-6970-85) > 15 TABLET, FILM COATED in 1 BLISTER PACK (0378-6970-32) 2 blister pack2019-05-140000-00-00NoNoCurrent