FDA.reportPublic FDA data

Roflumilast

Product NDC
72205-201
11-digit product format
722050201
Labeler code
72205
Product ID
72205-201_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
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
72205-201-11Roflumilast10 in 1 BLISTER PACKTABLET103
72205-201-13Roflumilast14 in 1 BLISTER PACKTABLET143
72205-201-24Roflumilast2 in 1 CARTONTABLET23
72205-201-30Roflumilast30 in 1 BOTTLETABLET303
72205-201-32Roflumilast2 in 1 CARTONTABLET23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-201-11EA - Each72205-201df07c6ad-3ce9-4fc7-8176-63c62d2a490512023-02-06
72205-201-13EA - Each72205-2019fe84c60-5b09-49c1-bcde-e8fc62a685c612023-05-05
72205-201-24EA - Each72205-20173274145-133e-458c-880d-3ae6d788ba9712022-11-07
72205-201-32EA - Each72205-20110734d78-22f1-4c1e-8e5d-e10e2b3ffd1012022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-201ROFLUMILAST TABLET [NOVADOZ PHARMACEUTICALS LLC]3Current NDC, Legacy NDC, 5 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
72205-201-117220502011110 in 1 BLISTER PACKHistorical
72205-201-137220502011314 in 1 BLISTER PACKHistorical
72205-201-24722050201242 BLISTER PACK in 1 CARTON (72205-201-24) / 10 TABLET in 1 BLISTER PACK (72205-201-11) 2 blister pack2022-09-240000-00-00NoNoCurrent
72205-201-307220502013030 TABLET in 1 BOTTLE (72205-201-30) 30 tablet2022-12-21NoNoHistorical
72205-201-32722050201322 BLISTER PACK in 1 CARTON (72205-201-32) / 14 TABLET in 1 BLISTER PACK (72205-201-13) 2 blister pack2022-09-240000-00-00NoNoCurrent