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NDC 31722-0623-32 Roflumilast 500 ug/1 Details

Roflumilast 500 ug/1

Roflumilast is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Camber Pharmaceuticals, Inc.. The primary component is ROFLUMILAST.

MedlinePlus Drug Summary

Roflumilast is used in people with severe chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways) to reduce the number of episodes or worsening of COPD symptoms. Roflumilast is in a class of medications called phosphodiesterase inhibitors. It works by decreasing swelling in the lungs.

Related Packages: 31722-0623-32
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Roflumilast

Product Information

NDC	31722-0623
Product ID	31722-623_fa61de4b-e3e1-e16c-e053-6394a90a6118
Associated GPIs
GCN Sequence Number	066612
GCN Sequence Number Description	roflumilast TABLET 500 MCG ORAL
HIC3	Z2X
HIC3 Description	PHOSPHODIESTERASE-4 (PDE4) INHIBITORS
GCN	28934
HICL Sequence Number	037123
HICL Sequence Number Description	ROFLUMILAST
Brand/Generic	Generic
Proprietary Name	Roflumilast
Proprietary Name Suffix	n/a
Non-Proprietary Name	Roflumilast
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	500
Active Ingredient Units	ug/1
Substance Name	ROFLUMILAST
Labeler Name	Camber Pharmaceuticals, Inc.
Pharmaceutical Class	Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA208213
Listing Certified Through	2024-12-31

Package

NDC 31722-0623-32 (31722062332)

Pricing Information	N/A
NDC Package Code	31722-623-32
Billing NDC	31722062332
Package	100 BLISTER PACK in 1 CARTON (31722-623-32) / 10 TABLET in 1 BLISTER PACK (31722-623-31)
Marketing Start Date	2022-10-15
NDC Exclude Flag	N