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NDC 68382-0624-31 Roflumilast 250 ug/1 Details
Roflumilast 250 ug/1
Roflumilast is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Pharmaceuticals USA 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: 68382-0624-31Last Updated: 04/28/2024
MedLinePlus Full Drug Details: Roflumilast
Product Information
| NDC | 68382-0624 |
|---|---|
| Product ID | 68382-624_09d92588-691b-4f6f-9cba-b1fa3548c24d |
| Associated GPIs | |
| GCN Sequence Number | 078213 |
| GCN Sequence Number Description | roflumilast TABLET 250 MCG ORAL |
| HIC3 | Z2X |
| HIC3 Description | PHOSPHODIESTERASE-4 (PDE4) INHIBITORS |
| GCN | 44498 |
| 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 | 250 |
| Active Ingredient Units | ug/1 |
| Substance Name | ROFLUMILAST |
| Labeler Name | Zydus Pharmaceuticals USA Inc. |
| Pharmaceutical Class | Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA208303 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 68382-0624-31 (68382062431)
| NDC Package Code | 68382-624-31 |
|---|---|
| Billing NDC | 68382062431 |
| Package | 1 BLISTER PACK in 1 CARTON (68382-624-31) / 28 TABLET in 1 BLISTER PACK |
| Marketing Start Date | 2023-05-18 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |