FDA.reportPublic FDA data

Tadalafil

Product NDC
0378-6976
Requested package NDC
0378-6976-91
11-digit product format
003786976
Labeler code
0378
Product ID
0378-6976_bb3aae41-95dc-4c00-966a-5c961292ef12
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tadalafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA200630
Marketing category
ANDA
Marketing start
2019-03-01
Marketing end
2021-09-30
Substance
TADALAFIL
Active strength
20 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
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 packagepackage0378-69760378-6976-91DDiscontinued 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A200630-001TADALAFILTADALAFIL20MGTABLET / ORAL2018-08-03

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 22:54:322026-06A200630-001TADALAFIL20MGTABLET / ORAL2018-08-03a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-6976-91EA - Each0378-6976b6c7da14-cb98-466f-bc0c-e39bdbe32f3412019-04-11
0378-6976-93EA - Each0378-6976027e30dd-21e5-42a0-bdb5-089af059c9dd12018-09-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-6976-910037869769160 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6976-91) 2019-03-012021-09-30NoNoCurrent