FDA.reportPublic FDA data

ROFLUMILAST

Product NDC
59651-801
11-digit product format
596510801
Labeler code
59651
Product ID
59651-801_586e58c7-172f-4c3f-a91f-045ea4d089fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROFLUMILAST
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA213298
Marketing category
ANDA
Marketing start
2025-01-31
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

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
A213298-001ROFLUMILASTROFLUMILAST500MCGTABLET / ORALAB2023-04-17
A213298-002ROFLUMILASTROFLUMILAST250MCGTABLET / ORALAB2025-01-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213298-001AB
A213298-002AB

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 22:54:322026-06A213298-001ROFLUMILAST500MCGTABLET / ORALAB2023-04-17a50c72e98297…
2026-08-01 22:54:322026-06A213298-002ROFLUMILAST250MCGTABLET / ORALAB2025-01-31a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A213298-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A213298-002AB1a50c72e98297…

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
ROFLUMILASTROFLUMILASTAurobindo Pharma Limited7cb11d48-6bb9-437b-bc7f-382050a2d3e62025-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213298
application number: ANDA213298
ndc (product): 59651-801

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 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
7cb11d48-6bb9-437b-bc7f-382050a2d3e6Available 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
59651-801-20ROFLUMILAST1 in 1 CARTONTABLET16
59651-801-20ROFLUMILAST20 in 1 BLISTER PACKTABLET206
59651-801-28ROFLUMILAST28 in 1 BLISTER PACKTABLET286
59651-801-28ROFLUMILAST1 in 1 CARTONTABLET16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-801-28EA - Each59651-801d1e7fb6e-ed54-4bac-8847-cc70d5c0854212026-03-17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-801ROFLUMILAST TABLET [AUROBINDO PHARMA LIMITED]6Current NDC, 4 package rows20250529_7cb11d48-6bb9-437b-bc7f-382050a2d3e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2001319roflumilast 250 MCG Oral TabletPSN7cb11d48-6bb9-437b-bc7f-382050a2d3e66
1091839roflumilast 500 MCG Oral TabletPSN7cb11d48-6bb9-437b-bc7f-382050a2d3e66
2001319roflumilast 0.25 MG Oral TabletSCD7cb11d48-6bb9-437b-bc7f-382050a2d3e66
1091839roflumilast 0.5 MG Oral TabletSCD7cb11d48-6bb9-437b-bc7f-382050a2d3e66
2001319roflumilast 250 MCG Oral TabletSY7cb11d48-6bb9-437b-bc7f-382050a2d3e66
1091839roflumilast 500 MCG Oral TabletSY7cb11d48-6bb9-437b-bc7f-382050a2d3e66

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-801-20596510801201 BLISTER PACK in 1 CARTON (59651-801-20) / 20 TABLET in 1 BLISTER PACK1 blister pack2025-01-31NoNoCurrent
59651-801-28596510801281 BLISTER PACK in 1 CARTON (59651-801-28) / 28 TABLET in 1 BLISTER PACK1 blister pack2025-01-31NoNoCurrent