FDA.reportPublic FDA data

Roflumilast

Product NDC
70771-1673
11-digit product format
707711673
Labeler code
70771
Product ID
70771-1673_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
2023-05-18
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

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 Identifiers#

Field, Values table
FieldValues
Unii0P6C6ZOP5U
Rxcui1091839, 2001319

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
70771-1673-2Roflumilast10 in 1 BLISTER PACKTABLET104
70771-1673-3Roflumilast2 in 1 CARTONTABLET24
70771-1673-8Roflumilast28 in 1 BLISTER PACKTABLET284
70771-1673-8Roflumilast1 in 1 CARTONTABLET14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1673ROFLUMILAST TABLET [ZYDUS LIFESCIENCES LIMITED]4Current NDC, 4 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 startSampleExclude flagStatus
70771-1673-27077116730210 in 1 BLISTER PACKHistorical
70771-1673-3707711673032 BLISTER PACK in 1 CARTON (70771-1673-3) / 10 TABLET in 1 BLISTER PACK (70771-1673-2) 2 blister pack2023-05-18NoNoHistorical
70771-1673-8707711673081 BLISTER PACK in 1 CARTON (70771-1673-8) / 28 TABLET in 1 BLISTER PACK1 blister pack2023-05-18NoNoHistorical