FDA.reportPublic FDA data

ROFLUMILAST

Product NDC
69292-630
11-digit product format
692920630
Labeler code
69292
Product ID
69292-630_c8a1a486-21dc-4e33-8e28-bb02456040ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROFLUMILAST
Dosage form
TABLET
Route
ORAL
Labeler
Amici Pharma Inc.
Application
ANDA208236
Marketing category
ANDA
Marketing start
2026-02-05
Substance
ROFLUMILAST
Active strength
250 ug/1
Pharmacologic classes
Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ROFLUMILAST
Listing expiration
2027-12-31

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
69292-630-10ROFLUMILAST1 in 1 CARTONTABLET12
69292-630-10ROFLUMILAST10 in 1 BLISTER PACKTABLET102
69292-630-14ROFLUMILAST1 in 1 CARTONTABLET12
69292-630-14ROFLUMILAST14 in 1 BLISTER PACKTABLET142
69292-630-20ROFLUMILAST10 in 1 BLISTER PACKTABLET102
69292-630-20ROFLUMILAST2 in 1 CARTONTABLET22
69292-630-28ROFLUMILAST14 in 1 BLISTER PACKTABLET142
69292-630-28ROFLUMILAST2 in 1 CARTONTABLET22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69292-630-10EA - Each69292-6304899c0a5-a431-4ced-bcd3-cdc267a734c912026-05-22
69292-630-20EA - Each69292-630c6f16828-2946-44c5-b414-3a03bc080f1512026-03-17
69292-630-28EA - Each69292-630f93f0b39-feb8-4399-8df3-642fcaf625ce12026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2001319roflumilast 250 MCG Oral TabletPSNcb3781ff-5350-4f9a-b247-0b04eb0f2b922
1091839roflumilast 500 MCG Oral TabletPSNcb3781ff-5350-4f9a-b247-0b04eb0f2b922
2001319roflumilast 0.25 MG Oral TabletSCDcb3781ff-5350-4f9a-b247-0b04eb0f2b922
1091839roflumilast 0.5 MG Oral TabletSCDcb3781ff-5350-4f9a-b247-0b04eb0f2b922
2001319roflumilast 250 MCG Oral TabletSYcb3781ff-5350-4f9a-b247-0b04eb0f2b922
1091839roflumilast 500 MCG Oral TabletSYcb3781ff-5350-4f9a-b247-0b04eb0f2b922

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69292-630-10692920630101 BLISTER PACK in 1 CARTON (69292-630-10) / 10 TABLET in 1 BLISTER PACK1 blister pack2026-02-05NoNoCurrent
69292-630-14692920630141 BLISTER PACK in 1 CARTON (69292-630-14) / 14 TABLET in 1 BLISTER PACK1 blister pack2026-02-05NoNoCurrent
69292-630-20692920630202 BLISTER PACK in 1 CARTON (69292-630-20) / 10 TABLET in 1 BLISTER PACK2 blister pack2026-02-05NoNoCurrent
69292-630-28692920630282 BLISTER PACK in 1 CARTON (69292-630-28) / 14 TABLET in 1 BLISTER PACK2 blister pack2026-02-05NoNoCurrent