FDA.reportPublic FDA data

Roflumilast

Product NDC
67877-480
11-digit product format
678770480
Labeler code
67877
Product ID
67877-480_955dd6eb-46f6-4c73-bcc8-bfd7b14ebc98
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Roflumilast
Dosage form
TABLET
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA212490
Marketing category
ANDA
Marketing start
2025-03-14
Substance
ROFLUMILAST
Active strength
500 ug/1
Pharmacologic classes
Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Roflumilast
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROFLUMILAST500 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0P6C6ZOP5U
Rxcui1091839, 2001319

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dcb8b904-8d4f-458b-b954-4eae028a2651Product name220250305
a1a743b6-f2e2-4044-a176-5c60c71ece24Product name120250102
6ac6be18-9820-1c07-b72b-a35dcf9d14c7Product name920240501

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-480-05Roflumilast500 in 1 BOTTLETABLET5005
67877-480-30Roflumilast30 in 1 BOTTLETABLET305
67877-480-33Roflumilast10 in 1 BLISTER PACKTABLET105
67877-480-33Roflumilast1 in 1 CARTONTABLET15
67877-480-90Roflumilast90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-480-90EA - Each67877-480efdca2ea-a449-40d9-b821-1fdefdfef12f12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-480ROFLUMILAST TABLET [ASCEND LABORATORIES, LLC]5Current NDC, 5 package rows20250316_93d72a99-64dc-4fde-a5b8-78331fa60787.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2001319roflumilast 250 MCG Oral TabletPSN93d72a99-64dc-4fde-a5b8-78331fa607875
1091839roflumilast 500 MCG Oral TabletPSN93d72a99-64dc-4fde-a5b8-78331fa607875
2001319roflumilast 0.25 MG Oral TabletSCD93d72a99-64dc-4fde-a5b8-78331fa607875
1091839roflumilast 0.5 MG Oral TabletSCD93d72a99-64dc-4fde-a5b8-78331fa607875
2001319roflumilast 250 MCG Oral TabletSY93d72a99-64dc-4fde-a5b8-78331fa607875
1091839roflumilast 500 MCG Oral TabletSY93d72a99-64dc-4fde-a5b8-78331fa607875
1091839roflumilast 500 MCG Oral TabletPSN30dd6eae-6435-cae1-e063-6294a90a003b1
1091839roflumilast 0.5 MG Oral TabletSCD30dd6eae-6435-cae1-e063-6294a90a003b1
1091839roflumilast 500 MCG Oral TabletSY30dd6eae-6435-cae1-e063-6294a90a003b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67877-480-0567877048005500 TABLET in 1 BOTTLE (67877-480-05) 500 tablet2025-03-14NoNoCurrent
67877-480-306787704803030 TABLET in 1 BOTTLE (67877-480-30) 30 tablet2025-03-14NoNoCurrent
67877-480-33678770480331 BLISTER PACK in 1 CARTON (67877-480-33) / 10 TABLET in 1 BLISTER PACK1 blister pack2025-03-14NoNoCurrent
67877-480-906787704809090 TABLET in 1 BOTTLE (67877-480-90) 90 tablet2025-03-14NoNoCurrent