FDA.reportPublic FDA data

Roflumilast

Product NDC
0378-1905
11-digit product format
003781905
Labeler code
0378
Product ID
0378-1905_60c7587f-e0db-41b8-94e2-67da4544c997
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Roflumilast
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA208257
Marketing category
ANDA
Marketing start
2022-10-19
Marketing end
0000-00-00
Substance
ROFLUMILAST
Active strength
500 ug/1
Pharmacologic classes
Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0378-1905DDiscontinued by firm2026-08-03
excluded packagepackage0378-19050378-1905-77DDiscontinued by firm2026-08-03
excluded packagepackage0378-19050378-1905-93DDiscontinued by firm2026-08-03

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
A208257-001ROFLUMILASTROFLUMILAST500MCGTABLET / ORAL2018-07-13

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 22:54:322026-06A208257-001ROFLUMILAST500MCGTABLET / ORAL2018-07-13a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-1905-77EA - Each0378-1905c9bf27c8-61fb-42c3-a367-f16da4ffe44e12022-11-07
0378-1905-93EA - Each0378-19053b8d2047-1a3a-4f93-ad92-1a9846e1b21b12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-1905ROFLUMILAST TABLET [MYLAN PHARMACEUTICALS INC.]3Legacy NDC20250104_0a917c07-edeb-44f0-a26c-8161166dc30b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-1905-770037819057790 TABLET in 1 BOTTLE, PLASTIC (0378-1905-77) 90 tablet2022-10-190000-00-00NoNoCurrent
0378-1905-930037819059330 TABLET in 1 BOTTLE, PLASTIC (0378-1905-93) 30 tablet2022-10-190000-00-00NoNoCurrent