NDC 10631-119 Ultravate X

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:
10631-119
Proprietary Name:
Ultravate X
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Code:
10631
Start Marketing Date: [9]
07-01-2012
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)

Code Structure Chart

Product Details

What is NDC 10631-119?

The NDC code 10631-119 is assigned by the FDA to the product Ultravate X which is product labeled by Ranbaxy Laboratories Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 10631-119-01 1 kit in 1 kit * 50 g in 1 tube (10631-102-50) * 225 g in 1 tube (10631-114-05). 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 Ultravate X?

Ultravate Ointment 0.05% is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in children under 12 years of age is not recommended.As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

Which are Ultravate X UNII Codes?

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

Which are Ultravate X 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 Ultravate X?

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: 1041718 - ammonium lactate 10 % Topical Cream
  • RxCUI: 1041718 - ammonium lactate 100 MG/ML Topical Cream
  • RxCUI: 1041718 - ammonium lactate (as neutralized lactic acid) 10 % Topical Cream
  • RxCUI: 1301695 - {1 (50000 MG) (halobetasol propionate 0.0005 MG/MG Topical Ointment) / 1 (225000 MG) (lactic acid 100 MG/ML Topical Cream) } Pack
  • RxCUI: 1301695 - halobetasol propionate 0.05 % Topical Ointment (50 GM) / lactid acid 10 % Topical Cream (225 GM Pack)

* Please review the disclaimer below.

Patient Education

Ammonium Lactate Topical


Ammonium lactate is used to treat xerosis (dry or scaly skin) and ichthyosis vulgaris (an inherited dry skin condition) in adults and children. Ammonium lactate is in a class of medications called alpha-hydroxy acids. It works by increasing skin hydration.
[Learn More]


Halobetasol Topical


Halobetasol topical is used to treat redness, swelling, itching, and discomfort of various skin conditions in adults and children 12 years of age and older, including plaque psoriasis (a skin disease in which red, scaly patches form on some areas of the body) and eczema (a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes). Halobetasol is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.
[Learn More]


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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".