FDA.reportPublic FDA data

ROFLUMILAST

Product NDC
43547-005
11-digit product format
435470005
Labeler code
43547
Product ID
43547-005_4251c764-7224-4f94-9de7-b6c76cb1f5cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
roflumilast
Dosage form
TABLET
Route
ORAL
Labeler
Solco Healthcare US, LLC.
Application
ANDA208299
Marketing category
ANDA
Marketing start
2022-05-10
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

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 Identifiers#

Field, Values table
FieldValues
Unii0P6C6ZOP5U
Rxcui1091839

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
43547-005-03ROFLUMILAST30 in 1 BOTTLETABLET301
43547-005-09ROFLUMILAST90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-005-03EA - Each43547-005fb2e641a-7a87-4d14-ac1d-d8b183cf4f8c12022-11-07
43547-005-09EA - Each43547-00593b705b0-9f66-48fd-baf0-a29d80d9566c12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-005ROFLUMILAST TABLET [SOLCO HEALTHCARE US, LLC.]1Current NDC, Legacy NDC, 2 package rows20220731_4251c764-7224-4f94-9de7-b6c76cb1f5cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1091839roflumilast 500 MCG Oral TabletPSN4251c764-7224-4f94-9de7-b6c76cb1f5cd1
1091839roflumilast 0.5 MG Oral TabletSCD4251c764-7224-4f94-9de7-b6c76cb1f5cd1
1091839roflumilast 500 MCG Oral TabletSY4251c764-7224-4f94-9de7-b6c76cb1f5cd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43547-005-034354700050330 TABLET in 1 BOTTLE (43547-005-03) 30 tablet2022-05-100000-00-00NoNoCurrent
43547-005-094354700050990 TABLET in 1 BOTTLE (43547-005-09) 90 tablet2022-05-100000-00-00NoNoCurrent