FDA.reportPublic FDA data

Daliresp

Product NDC
0310-0095
11-digit product format
003100095
Labeler code
0310
Product ID
0310-0095_11cd495f-c5cf-4076-b69c-af202ec2a8a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
roflumilast
Dosage form
TABLET
Route
ORAL
Labeler
AstraZeneca Pharmaceuticals LP
Application
NDA022522
Marketing category
NDA
Marketing start
2015-07-01
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
Daliresp
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROFLUMILAST500 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0P6C6ZOP5U
Rxcui1091839, 1091843, 2001319, 2001321

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
0310-0095-30Daliresp30 in 1 BOTTLE, PLASTICTABLET3015
0310-0095-39Daliresp2 in 1 BLISTER PACKTABLET215
0310-0095-39Daliresp10 in 1 BOX, UNIT-DOSETABLET1015
0310-0095-90Daliresp90 in 1 BOTTLE, PLASTICTABLET9015
0310-0095-95Daliresp1 in 1 BLISTER PACKTABLET115
0310-0095-95Daliresp7 in 1 BOX, UNIT-DOSETABLET715

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0310-0095-30EA - Each0310-009504d1a507-ac28-4375-bcae-4c85c24571c512015-07-20
0310-0095-39EA - Each0310-00955892fc47-1cee-4b7e-a956-0c2f43d9d9ba12015-07-20
0310-0095-90EA - Each0310-0095bb8995bc-285e-4a9c-ae63-45b0433b822412015-07-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0310-0095DALIRESP (ROFLUMILAST) TABLET [ASTRAZENECA PHARMACEUTICALS LP]14Current NDC, Legacy NDC, 6 package rows20241120_c9a1d0a8-581f-4f91-a2b8-f419192d0ebf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2001321Daliresp 250 MCG Oral TabletPSNc9a1d0a8-581f-4f91-a2b8-f419192d0ebf15
1091843Daliresp 500 MCG Oral TabletPSNc9a1d0a8-581f-4f91-a2b8-f419192d0ebf15
2001319roflumilast 250 MCG Oral TabletPSNc9a1d0a8-581f-4f91-a2b8-f419192d0ebf15
1091839roflumilast 500 MCG Oral TabletPSNc9a1d0a8-581f-4f91-a2b8-f419192d0ebf15
2001321roflumilast 0.25 MG Oral Tablet [Daliresp]SBDc9a1d0a8-581f-4f91-a2b8-f419192d0ebf15
1091843roflumilast 0.5 MG Oral Tablet [Daliresp]SBDc9a1d0a8-581f-4f91-a2b8-f419192d0ebf15
2001319roflumilast 0.25 MG Oral TabletSCDc9a1d0a8-581f-4f91-a2b8-f419192d0ebf15
1091839roflumilast 0.5 MG Oral TabletSCDc9a1d0a8-581f-4f91-a2b8-f419192d0ebf15
2001321Daliresp 0.25 MG Oral TabletSYc9a1d0a8-581f-4f91-a2b8-f419192d0ebf15
1091843Daliresp 0.5 MG Oral TabletSYc9a1d0a8-581f-4f91-a2b8-f419192d0ebf15
2001321Daliresp 250 MCG Oral TabletSYc9a1d0a8-581f-4f91-a2b8-f419192d0ebf15
1091843Daliresp 500 MCG Oral TabletSYc9a1d0a8-581f-4f91-a2b8-f419192d0ebf15
2001319roflumilast 250 MCG Oral TabletSYc9a1d0a8-581f-4f91-a2b8-f419192d0ebf15
1091839roflumilast 500 MCG Oral TabletSYc9a1d0a8-581f-4f91-a2b8-f419192d0ebf15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0310-0095-300031000953030 TABLET in 1 BOTTLE, PLASTIC (0310-0095-30) 30 tablet2015-07-010000-00-00NoNoCurrent
0310-0095-39003100095392 in 1 BLISTER PACKHistorical
0310-0095-900031000959090 TABLET in 1 BOTTLE, PLASTIC (0310-0095-90) 90 tablet2015-07-010000-00-00NoNoCurrent
0310-0095-95003100095957 BLISTER PACK in 1 BOX, UNIT-DOSE (0310-0095-95) > 1 TABLET in 1 BLISTER PACK7 blister pack2015-07-010000-00-00NoNoCurrent