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NDC 55513-0137-95 Otezla 30 mg/1 Details
Otezla 30 mg/1
Otezla is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amgen Inc. The primary component is APREMILAST.
MedlinePlus Drug Summary
Apremilast is used to treat psoriatic arthritis (a condition that causes joint pain and swelling and scales on the skin). It is also used to treat moderate to severe plaque psoriasis (skin disease in which red, scaly patches form on some areas of the body) in people who may benefit from medications or phototherapy (a treatment that involves exposing the skin to ultraviolet light). Apremilast is used to treat ulcers in the mouth in people with Behcet's syndrome (a disorder that causes blood vessel swelling in the body). Apremilast is in a class of medications called phosphodiesterase inhibitors. It works by blocking the action of certain natural substances in the body that cause inflammation.
Related Packages: 55513-0137-95Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Apremilast
Product Information
| NDC | 55513-0137 |
|---|---|
| Product ID | 55513-137_3e8d8499-e557-4e75-8655-554a1a2d0b04 |
| Associated GPIs | 66700015000330 |
| GCN Sequence Number | 072075 |
| GCN Sequence Number Description | apremilast TABLET 30 MG ORAL |
| HIC3 | S2Z |
| HIC3 Description | ANTI-INFLAMMATORY,PHOSPHODIESTERASE-4(PDE4) INHIB. |
| GCN | 36172 |
| HICL Sequence Number | 040967 |
| HICL Sequence Number Description | APREMILAST |
| Brand/Generic | Brand |
| Proprietary Name | Otezla |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | apremilast |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 30 |
| Active Ingredient Units | mg/1 |
| Substance Name | APREMILAST |
| Labeler Name | Amgen Inc |
| Pharmaceutical Class | Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA205437 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 55513-0137-95 (55513013795)
| NDC Package Code | 55513-137-95 |
|---|---|
| Billing NDC | 55513013795 |
| Package | 1 BLISTER PACK in 1 CARTON (55513-137-95) / 28 TABLET, FILM COATED in 1 BLISTER PACK |
| Marketing Start Date | 2020-02-26 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |