FDA.reportPublic FDA data

Roflumilast

Product NDC
70771-1674
11-digit product format
707711674
Labeler code
70771
Product ID
70771-1674_eb40db9e-ddc1-4041-aac5-ff0f2c478fc6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Roflumilast
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA208303
Marketing category
ANDA
Marketing start
2022-10-03
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
A208303-001ROFLUMILASTROFLUMILAST500MCGTABLET / ORALAB2022-02-10
A208303-002ROFLUMILASTROFLUMILAST250MCGTABLET / 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
A208303-001AB
A208303-002AB

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 22:54:322026-06A208303-001ROFLUMILAST500MCGTABLET / ORALAB2022-02-10a50c72e98297…
2026-08-01 22:54:322026-06A208303-002ROFLUMILAST250MCGTABLET / ORALAB2023-04-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A208303-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A208303-002AB1a50c72e98297…

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
RoflumilastROFLUMILASTZydus Pharmaceuticals USA Inc.84145572-f320-4c3f-ab29-bd9f6c18746c2024-08-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208303
application number: ANDA208303
RoflumilastROFLUMILASTZydus Lifesciences Limitede87287bd-eae3-46c3-9072-04800aeabf402024-08-12Exact identifier
application applno (ANDA): 208303
application number: ANDA208303
ndc (product): 70771-1674

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
e87287bd-eae3-46c3-9072-04800aeabf40Available 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
70771-1674-3Roflumilast30 in 1 BOTTLETABLET304
70771-1674-9Roflumilast90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1674ROFLUMILAST TABLET [ZYDUS LIFESCIENCES LIMITED]4Current NDC, Legacy NDC, 2 package rows20240815_e87287bd-eae3-46c3-9072-04800aeabf40.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2001319roflumilast 250 MCG Oral TabletPSNe87287bd-eae3-46c3-9072-04800aeabf404
1091839roflumilast 500 MCG Oral TabletPSNe87287bd-eae3-46c3-9072-04800aeabf404
2001319roflumilast 0.25 MG Oral TabletSCDe87287bd-eae3-46c3-9072-04800aeabf404
1091839roflumilast 0.5 MG Oral TabletSCDe87287bd-eae3-46c3-9072-04800aeabf404
2001319roflumilast 250 MCG Oral TabletSYe87287bd-eae3-46c3-9072-04800aeabf404
1091839roflumilast 500 MCG Oral TabletSYe87287bd-eae3-46c3-9072-04800aeabf404

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1674-37077116740330 TABLET in 1 BOTTLE (70771-1674-3) 30 tablet2022-10-030000-00-00NoNoCurrent
70771-1674-97077116740990 TABLET in 1 BOTTLE (70771-1674-9) 90 tablet2022-10-030000-00-00NoNoCurrent