FDA.reportPublic FDA data

ROFLUMILAST

Product NDC
42571-369
11-digit product format
425710369
Labeler code
42571
Product ID
42571-369_3aacb2a6-70a4-650d-e063-6394a90af9fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROFLUMILAST
Dosage form
TABLET
Route
ORAL
Labeler
Micro Labs Limited
Application
ANDA208180
Marketing category
ANDA
Marketing start
2023-05-01
Substance
ROFLUMILAST
Active strength
250 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
ROFLUMILAST250 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
42571-369-05ROFLUMILAST500 in 1 BOTTLETABLET5006
42571-369-11ROFLUMILAST10 in 1 CARTONTABLET106
42571-369-30ROFLUMILAST30 in 1 BOTTLETABLET306
42571-369-32ROFLUMILAST10 in 1 BLISTER PACKTABLET106
42571-369-83ROFLUMILAST28 in 1 BOTTLETABLET286
42571-369-90ROFLUMILAST90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-369-83EA - Each42571-369fbee6b5d-92a1-4be4-9007-aba0444c7ee712023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-369ROFLUMILAST TABLET ROFLUMILAST TABLET [MICRO LABS LIMITED]5Current NDC, 6 package rows20230502_dc2a689f-cfa4-4863-9623-a9813dcf86a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2001319roflumilast 250 MCG Oral TabletPSNdc2a689f-cfa4-4863-9623-a9813dcf86a96
1091839roflumilast 500 MCG Oral TabletPSNdc2a689f-cfa4-4863-9623-a9813dcf86a96
2001319roflumilast 0.25 MG Oral TabletSCDdc2a689f-cfa4-4863-9623-a9813dcf86a96
1091839roflumilast 0.5 MG Oral TabletSCDdc2a689f-cfa4-4863-9623-a9813dcf86a96
2001319roflumilast 250 MCG Oral TabletSYdc2a689f-cfa4-4863-9623-a9813dcf86a96
1091839roflumilast 500 MCG Oral TabletSYdc2a689f-cfa4-4863-9623-a9813dcf86a96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42571-369-0542571036905500 TABLET in 1 BOTTLE (42571-369-05) 500 tablet2023-05-01NoNoCurrent
42571-369-114257103691110 BLISTER PACK in 1 CARTON (42571-369-11) / 10 TABLET in 1 BLISTER PACK (42571-369-32) 10 blister pack2023-05-01NoNoCurrent
42571-369-304257103693030 TABLET in 1 BOTTLE (42571-369-30) 30 tablet2023-05-01NoNoCurrent
42571-369-324257103693210 in 1 BLISTER PACKHistorical
42571-369-834257103698328 TABLET in 1 BOTTLE (42571-369-83) 28 tablet2023-05-01NoNoCurrent
42571-369-904257103699090 TABLET in 1 BOTTLE (42571-369-90) 90 tablet2023-05-01NoNoCurrent