Roflumilast by Zydus Lifesciences Limited ROFLUMILAST tablet

Roflumilast by

Drug Labeling and Warnings

Roflumilast by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 70771-1674-3

Roflumilast Tablets, 500 mcg

30 tablets

Rx only

NDC: 70771-1673-8

Roflumilast Tablets, 250 mcg

Blister pack of 28 tablets

Rx only

INGREDIENTS AND APPEARANCE

ROFLUMILAST 
roflumilast tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1674
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ROFLUMILAST (UNII: 0P6C6ZOP5U) (ROFLUMILAST - UNII:0P6C6ZOP5U)	ROFLUMILAST	500 ug

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	WHITE (off-white)	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	T5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1674-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	10/03/2022
2	NDC: 70771-1674-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	10/03/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA208303	10/03/2022

ROFLUMILAST 
roflumilast tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1673
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ROFLUMILAST (UNII: 0P6C6ZOP5U) (ROFLUMILAST - UNII:0P6C6ZOP5U)	ROFLUMILAST	250 ug

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	WHITE (off-white)	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	T6
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1673-8	1 in 1 CARTON	05/18/2023
1		28 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 70771-1673-3	2 in 1 CARTON	05/18/2023
2	NDC: 70771-1673-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA208303	05/18/2023

Labeler - Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Lifesciences Limited		863362789	ANALYSIS(70771-1673, 70771-1674) , MANUFACTURE(70771-1673, 70771-1674)