FDA.reportPublic FDA data

Daliresp

Product NDC
0310-0088
11-digit product format
003100088
Labeler code
0310
Product ID
0310-0088_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
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0310-00880310-0088-95DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022522-001DALIRESPROFLUMILAST500MCGTABLET / ORALABRLD, RS2011-02-28
N022522-002DALIRESPROFLUMILAST250MCGTABLET / ORALABRLD2018-01-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N022522-001AB
N022522-002AB

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 22:54:322026-06N022522-001DALIRESP500MCGTABLET / ORALABRLD, RS2011-02-28a50c72e98297…
2026-08-01 22:54:322026-06N022522-002DALIRESP250MCGTABLET / ORALABRLD2018-01-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N022522-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N022522-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DalirespROFLUMILASTAstraZeneca Pharmaceuticals LPc9a1d0a8-581f-4f91-a2b8-f419192d0ebf2020-03-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 022522
application number: NDA022522
ndc (product): 0310-0088

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROFLUMILAST250 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0P6C6ZOP5UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1091839Internal RxNorm lookup
1091843Internal RxNorm lookup
2001319Internal RxNorm lookup
2001321Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c9a1d0a8-581f-4f91-a2b8-f419192d0ebfAvailable on FDA.report

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
0310-0088-28Daliresp1 in 1 BOX, UNIT-DOSETABLET115
0310-0088-28Daliresp28 in 1 BLISTER PACKTABLET2815
0310-0088-39Daliresp10 in 1 BOX, UNIT-DOSETABLET1015
0310-0088-39Daliresp2 in 1 BLISTER PACKTABLET215
0310-0088-95Daliresp28 in 1 BLISTER PACKTABLET2815
0310-0088-95Daliresp1 in 1 BOX, UNIT-DOSETABLET115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0310-0088-28EA - Each0310-0088e56115ef-10ac-4b69-ad4d-a2e27e6637a012018-04-19
0310-0088-39EA - Each0310-00881a92369f-bfde-4d7e-a483-58548ede31f112018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0310-0088DALIRESP (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
0310-0088-28003100088281 BLISTER PACK in 1 BOX, UNIT-DOSE (0310-0088-28) / 28 TABLET in 1 BLISTER PACK1 blister pack2018-01-230000-00-00NoNoCurrent
0310-0088-390031000883910 BLISTER PACK in 1 BOX, UNIT-DOSE (0310-0088-39) / 2 TABLET in 1 BLISTER PACK10 blister pack2018-01-230000-00-00NoNoCurrent
0310-0088-95003100088951 BLISTER PACK in 1 BOX, UNIT-DOSE (0310-0088-95) > 28 TABLET in 1 BLISTER PACK1 blister pack2018-01-230000-00-00NoNoCurrent