NDC 54868-5676 Oracea

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:
54868-5676
Proprietary Name:
Oracea
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Code:
54868
Start Marketing Date: [9]
09-29-2006
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
BROWN (C48332 - BEIGE)
Shape:
CAPSULE (C48336)
Size(s):
18 MM
Imprint(s):
CGPI;40
Score:
1

Code Structure Chart

Product Details

What is NDC 54868-5676?

The NDC code 54868-5676 is assigned by the FDA to the product Oracea which is product labeled by Physicians Total Care, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 54868-5676-0 30 capsule, delayed release pellets in 1 bottle . 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 Oracea?

This medication is used to treat a certain type of skin condition called rosacea. It helps to reduce the number of pimples and bumps on the face, but it may not decrease redness. It works by reducing skin inflammation caused by rosacea. Although doxycycline belongs to the class of antibiotics known as tetracyclines, this product does not work as an antibiotic because it does not stop the growth of bacteria. Therefore, do not use this product to treat any infection, including viral infections (such as the common cold, flu). Use this medication only as prescribed by your doctor.

Which are Oracea UNII Codes?

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

Which are Oracea 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 Oracea?

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:
  • RxCUI: 901399 - doxycycline anhydrous 40 MG Delayed Release Oral Capsule
  • RxCUI: 901401 - Oracea 40 MG Delayed Release Oral Capsule
  • RxCUI: 901401 - doxycycline anhydrous 40 MG Delayed Release Oral Capsule [Oracea]

* Please review the disclaimer below.

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".