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

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
A208236-001ROFLUMILASTROFLUMILAST500MCGTABLET / ORALAB2018-10-03
A208236-002ROFLUMILASTROFLUMILAST250MCGTABLET / ORALAB2023-10-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208236-001AB
A208236-002AB

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 22:54:322026-06A208236-001ROFLUMILAST500MCGTABLET / ORALAB2018-10-03a50c72e98297…
2026-08-01 22:54:322026-06A208236-002ROFLUMILAST250MCGTABLET / ORALAB2023-10-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A208236-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A208236-002AB1a50c72e98297…

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
RoflumilastROFLUMILASTJubilant Cadista Pharmaceuticals Inc.aaa81c1b-f63d-4e61-8bfa-9d42d92043c72026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208236
application number: ANDA208236
ROFLUMILASTROFLUMILASTAmici Pharma Inc.cb3781ff-5350-4f9a-b247-0b04eb0f2b922026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208236
application number: ANDA208236
ndc (product): 69292-630

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 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
cb3781ff-5350-4f9a-b247-0b04eb0f2b92Available 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
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