NDC 68151-0088 Calcitriol

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.

Get all the details for National Drug Code (NDC) 68151-0088 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
68151-0088
Proprietary Name:
Calcitriol
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Code:
68151
FDA Application Number: [6]
NDA018044
Marketing Category: [8]
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date: [9]
08-26-2009
Listing Expiration Date: [11]
12-31-2018
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
ORANGE (C48331 - LIGHT ORANGE)
Shape:
CAPSULE (C48336)
Size(s):
10 MM
Imprint(s):
R25
Score:
1

Code Structure Chart

Product Details

What is NDC 68151-0088?

The NDC code 68151-0088 is assigned by the FDA to the product Calcitriol which is product labeled by Carilion Materials Management. The product's dosage form is . The product is distributed in a single package with assigned NDC code 68151-0088-0 1 capsule in 1 package . 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 Calcitriol?

Calcitriol is a man-made active form of vitamin D. Most people get enough vitamin D from exposure to the sun and from fortified food products (e.g., dairy products, vitamins). Vitamin D helps control parathyroid hormone and the levels of certain minerals (e.g., calcium, phosphorus) that are needed for building and keeping strong bones. Before regular vitamin D can be used by the body, it needs to be changed to the active form by the liver and kidneys. Calcitriol is used in patients with kidney disease who can't make enough of the active form of Vitamin D. This medication is also used to prevent and treat certain types of calcium/phosphorus/parathyroid problems that can happen with long-term kidney dialysis or hypoparathyroidism. Calcitriol is usually used along with specific diet recommendations and sometimes other medications.

Which are Calcitriol UNII Codes?

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

Which are Calcitriol 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 Calcitriol?

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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Product Footnotes

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

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".