FDA.reportPublic FDA data

ROFLUMILAST

Product NDC
42571-259
11-digit product format
425710259
Labeler code
42571
Product ID
42571-259_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
2022-10-19
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

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
A208180-001ROFLUMILASTROFLUMILAST500MCGTABLET / ORALAB2019-03-22
A208180-002ROFLUMILASTROFLUMILAST250MCGTABLET / ORALAB2023-04-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208180-001AB
A208180-002AB

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 22:54:322026-06A208180-001ROFLUMILAST500MCGTABLET / ORALAB2019-03-22a50c72e98297…
2026-08-01 22:54:322026-06A208180-002ROFLUMILAST250MCGTABLET / ORALAB2023-04-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A208180-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A208180-002AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ROFLUMILASTROFLUMILASTMicro Labs Limiteddc2a689f-cfa4-4863-9623-a9813dcf86a92025-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208180
application number: ANDA208180
ndc (product): 42571-259
ROFLUMILASTROFLUMILASTBryant Ranch Prepackfa9c3bea-a04d-4ea9-ade9-ee8d9f6b1f722024-08-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208180
application number: ANDA208180

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 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 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dc2a689f-cfa4-4863-9623-a9813dcf86a9Available 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
42571-259-05ROFLUMILAST500 in 1 BOTTLETABLET5006
42571-259-17ROFLUMILAST11 in 1 CARTONTABLET116
42571-259-30ROFLUMILAST30 in 1 BOTTLETABLET306
42571-259-32ROFLUMILAST10 in 1 BLISTER PACKTABLET106
42571-259-90ROFLUMILAST90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-259-30EA - Each42571-2599348a71a-7cca-4193-a549-dbeaaf99913c12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-259ROFLUMILAST TABLET ROFLUMILAST TABLET [MICRO LABS LIMITED]5Current NDC, Legacy NDC, 5 package rows20230502_dc2a689f-cfa4-4863-9623-a9813dcf86a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1091839roflumilast 500 MCG Oral TabletPSNfa9c3bea-a04d-4ea9-ade9-ee8d9f6b1f72100
1091839roflumilast 0.5 MG Oral TabletSCDfa9c3bea-a04d-4ea9-ade9-ee8d9f6b1f72100
1091839roflumilast 500 MCG Oral TabletSYfa9c3bea-a04d-4ea9-ade9-ee8d9f6b1f72100
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 startMarketing endSampleExclude flagStatus
42571-259-0542571025905500 TABLET in 1 BOTTLE (42571-259-05) 500 tablet2022-10-190000-00-00NoNoCurrent
42571-259-174257102591711 BLISTER PACK in 1 CARTON (42571-259-17) / 10 TABLET in 1 BLISTER PACK (42571-259-32) 11 blister pack2022-10-190000-00-00NoNoCurrent
42571-259-304257102593030 TABLET in 1 BOTTLE (42571-259-30) 30 tablet2022-10-190000-00-00NoNoCurrent
42571-259-324257102593210 in 1 BLISTER PACKHistorical
42571-259-904257102599090 TABLET in 1 BOTTLE (42571-259-90) 90 tablet2022-10-190000-00-00NoNoCurrent