Cytra-k Crystals
NDC 60258-005
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
Cytra-k Crystals is a UNAPPROVED DRUG OTHER-approved product labeled by Cypress Pharmaceutical, Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a red product. This product entry covers the primary NDC 60258-005 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
60258-005
Proprietary Name:
Cytra-k Crystals
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
60258
Product Label ID:
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Marketing Timeline
Start Marketing Date: [9]
05-01-2003
Listing Expiration Date: [11]
12-31-2018
Exclude Flag: [12]
I
Product Characteristics
Color(s):
RED (C48326 - FD&C RED DYE #3)
Flavor(s):
Code Structure Chart
Product Details
What is NDC 60258-005?
The NDC code 60258-005 is assigned by the FDA to the product Cytra-k Crystals. This pharmaceutical product is labeled by Cypress Pharmaceutical, Inc. and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 60258-005-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
CYTRA-K CRYSTALS is an effective alkalinizing agent useful in those conditions where long-term maintenance of an alkaline urine is desirable, such as in patients with uric acid and cystine calculi of the urinary tract, especially when the administration of sodium salts is undesirable or contraindicated. In addition, it is a valuable adjuvant when administered with uricosuric agents in gout therapy, since urates tend to crystallize out of an acid urine. It is also effective in correcting the acidosis of certain renal tubular disorders where the administration of potassium citrate may be preferable. CYTRA-K CRYSTALS is highly concentrated, and when administered after meals and before bedtime, allows one to maintain an alkaline urinary pH around the clock, usually without the necessity of a 2 A.M. dose. CYTRA-K CRYSTALS alkalinizes the urine without producing a systemic alkalosis in recommended dosage. It is highly palatable, pleasant tasting, and tolerable, even when administered for long periods. Potassium citrate does not neutralize the gastric juice or disturb digestion.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- POTASSIUM CITRATE (UNII: EE90ONI6FF)
- ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (Active Moiety)
- CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
Which are the Inactive Ingredients associated 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:
- SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)
What is the NDC to RxNorm Crosswalk for this product?
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: 1652634 - potassium citrate 3300 MG / citric acid 1002 MG Powder for Oral Solution
- RxCUI: 1652634 - citric acid 1002 MG / potassium citrate 3300 MG Powder for Oral Solution
- RxCUI: 1652634 - Citric Acid 1002 MG / K+ citrate 3300 MG Powder for Oral Solution
- RxCUI: 1652634 - Citric Acid 1002 MG / Pot citrate 3300 MG Powder for Oral Solution
- RxCUI: 1652638 - CYTRA-K CRYSTALS 3300 MG / 1002 MG Powder for Oral Solution
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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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".
