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NDC 55513-0369-55 Otezla Details
Otezla
Otezla is a KIT in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amgen Inc. The primary component is .
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: 55513-0369-55Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Apremilast
Product Information
NDC | 55513-0369 |
---|---|
Product ID | 55513-369_3e8d8499-e557-4e75-8655-554a1a2d0b04 |
Associated GPIs | 6670001500B720 |
GCN Sequence Number | 073370 |
GCN Sequence Number Description | apremilast TAB DS PK 10-20-30MG ORAL |
HIC3 | S2Z |
HIC3 Description | ANTI-INFLAMMATORY,PHOSPHODIESTERASE-4(PDE4) INHIB. |
GCN | 37765 |
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 | KIT |
Route | n/a |
Active Ingredient Strength | n/a |
Active Ingredient Units | n/a |
Substance Name | n/a |
Labeler Name | Amgen Inc |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | NDA |
Application Number | NDA205437 |
Listing Certified Through | 2024-12-31 |
Package
NDC 55513-0369-55 (55513036955)
NDC Package Code | 55513-369-55 |
---|---|
Billing NDC | 55513036955 |
Package | 1 BLISTER PACK in 1 CARTON (55513-369-55) / 1 KIT in 1 BLISTER PACK |
Marketing Start Date | 2020-02-26 |
NDC Exclude Flag | N |
Pricing Information | N/A |