NDC 59572-630 Otezla

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
59572-630
Proprietary Name:
Otezla
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Code:
59572
Start Marketing Date: [9]
03-25-2014
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
PINK (C48328)
BROWN (C48332)
WHITE (C48325 - BEIGE)
Shape:
DIAMOND (C48338)
Size(s):
8 MM
10 MM
12 MM
Imprint(s):
APR;10
20;APR
30;APR
Score:
1

Code Structure Chart

Product Details

What is NDC 59572-630?

The NDC code 59572-630 is assigned by the FDA to the product Otezla which is product labeled by Celgene Corporation. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 59572-630-27 1 kit in 1 blister pack , 59572-630-99 1 kit in 1 blister pack . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Otezla?

This medication is used to treat a certain type of arthritis (psoriatic arthritis). Apremilast is also used to treat a certain type of skin condition (moderate to severe plaque psoriasis). Apremilast belongs to a class of drugs known as phosphodiesterase 4 (PDE4) inhibitors. For the treatment of psoriatic arthritis, it decreases pain and swelling, and may help improve flexibility in the affected joints. For the treatment of plaque psoriasis, it may help to reduce the redness, thickening, and scaling of the skin that occurs with this condition. Apremilast is also used to treat mouth sores in people who have Behcet's disease. It helps to reduce the pain and improve the healing of these mouth sores.

Which are Otezla UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Otezla Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Otezla?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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Patient Education

Apremilast


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.
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Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".