FDA.reportPublic FDA data

Roflumilast

Product NDC
68382-969
11-digit product format
683820969
Labeler code
68382
Product ID
68382-969_70642eb6-1ced-4f90-85b2-7d4238c197d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Roflumilast
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
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

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, 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
68382-969-06Roflumilast30 in 1 BOTTLETABLET303
68382-969-16Roflumilast90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-969-06EA - Each68382-96971875f13-65b7-4db8-b211-4a475c0b236612022-11-07
68382-969-16EA - Each68382-9698fb792ed-faa4-4282-87ef-0ee31191be4312022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-969ROFLUMILAST TABLET [ZYDUS PHARMACEUTICALS USA INC.]3Current NDC, Legacy NDC, 2 package rows20240821_84145572-f320-4c3f-ab29-bd9f6c18746c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2001319roflumilast 250 MCG Oral TabletPSN84145572-f320-4c3f-ab29-bd9f6c18746c3
1091839roflumilast 500 MCG Oral TabletPSN84145572-f320-4c3f-ab29-bd9f6c18746c3
2001319roflumilast 0.25 MG Oral TabletSCD84145572-f320-4c3f-ab29-bd9f6c18746c3
1091839roflumilast 0.5 MG Oral TabletSCD84145572-f320-4c3f-ab29-bd9f6c18746c3
2001319roflumilast 250 MCG Oral TabletSY84145572-f320-4c3f-ab29-bd9f6c18746c3
1091839roflumilast 500 MCG Oral TabletSY84145572-f320-4c3f-ab29-bd9f6c18746c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-969-066838209690630 TABLET in 1 BOTTLE (68382-969-06) 30 tablet2022-10-030000-00-00NoNoCurrent
68382-969-166838209691690 TABLET in 1 BOTTLE (68382-969-16) 90 tablet2022-10-030000-00-00NoNoCurrent