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NDC 42571-0259-05 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 Micro Labs Limited. 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: 42571-0259-05Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Roflumilast
Product Information
| NDC | 42571-0259 |
|---|---|
| Product ID | 42571-259_fa1415ba-cf19-8b70-e053-6394a90af9a6 |
| 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 | Micro Labs Limited |
| Pharmaceutical Class | Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA208180 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 42571-0259-05 (42571025905)
| NDC Package Code | 42571-259-05 |
|---|---|
| Billing NDC | 42571025905 |
| Package | 500 TABLET in 1 BOTTLE (42571-259-05) |
| Marketing Start Date | 2022-10-19 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |