FDA.reportPublic FDA data

Roflumilast

Product NDC
72205-200
11-digit product format
722050200
Labeler code
72205
Product ID
72205-200_b56e7d3f-9930-43fa-baf4-63f9cee750f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Roflumilast
Dosage form
TABLET
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA208256
Marketing category
ANDA
Marketing start
2022-09-07
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
A208256-001ROFLUMILASTROFLUMILAST250MCGTABLET / ORALAB2022-09-07
A208256-002ROFLUMILASTROFLUMILAST500MCGTABLET / ORALAB2022-09-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208256-001AB
A208256-002AB

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 22:54:322026-06A208256-001ROFLUMILAST250MCGTABLET / ORALAB2022-09-07a50c72e98297…
2026-08-01 22:54:322026-06A208256-002ROFLUMILAST500MCGTABLET / ORALAB2022-09-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A208256-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A208256-002AB1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RoflumilastROFLUMILASTMajor Pharmaceuticalsca22f3e0-6f33-4f1c-97e5-0c962891067a2025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208256
application number: ANDA208256
RoflumilastROFLUMILASTMAJOR PHARMACEUTICALSc51b80f3-a591-4db9-81b4-b91603e35d7c2025-12-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208256
application number: ANDA208256
RoflumilastROFLUMILASTNovadoz Pharmaceuticals LLC4d25f69c-58b7-4e2a-b835-4d0c76a83c7c2024-08-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208256
application number: ANDA208256
ndc (product): 72205-200

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
4d25f69c-58b7-4e2a-b835-4d0c76a83c7cAvailable 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
72205-200-06Roflumilast10 in 1 CARTONTABLET103
72205-200-11Roflumilast10 in 1 BLISTER PACKTABLET103
72205-200-30Roflumilast30 in 1 BOTTLETABLET303
72205-200-90Roflumilast90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-200-30EA - Each72205-200015f9d85-d981-4de7-a9b5-16f96ad84dee12022-11-07
72205-200-90EA - Each72205-200d0e8287a-ca75-4fd4-a5e6-f29ea6bb634312022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-200ROFLUMILAST TABLET [NOVADOZ PHARMACEUTICALS LLC]3Current NDC, Legacy NDC, 4 package rows20240829_4d25f69c-58b7-4e2a-b835-4d0c76a83c7c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2001319roflumilast 250 MCG Oral TabletPSN4d25f69c-58b7-4e2a-b835-4d0c76a83c7c3
1091839roflumilast 500 MCG Oral TabletPSN4d25f69c-58b7-4e2a-b835-4d0c76a83c7c3
2001319roflumilast 0.25 MG Oral TabletSCD4d25f69c-58b7-4e2a-b835-4d0c76a83c7c3
1091839roflumilast 0.5 MG Oral TabletSCD4d25f69c-58b7-4e2a-b835-4d0c76a83c7c3
2001319roflumilast 250 MCG Oral TabletSY4d25f69c-58b7-4e2a-b835-4d0c76a83c7c3
1091839roflumilast 500 MCG Oral TabletSY4d25f69c-58b7-4e2a-b835-4d0c76a83c7c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72205-200-067220502000610 BLISTER PACK in 1 CARTON (72205-200-06) / 10 TABLET in 1 BLISTER PACK (72205-200-11) 10 blister pack2022-09-240000-00-00NoNoCurrent
72205-200-117220502001110 in 1 BLISTER PACKHistorical
72205-200-307220502003030 TABLET in 1 BOTTLE (72205-200-30) 30 tablet2022-09-240000-00-00NoNoCurrent
72205-200-907220502009090 TABLET in 1 BOTTLE (72205-200-90) 90 tablet2022-09-240000-00-00NoNoCurrent