NDC 0378-9045 Cystagon
Cysteamine Bitartrate Capsule Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 0378 - Mylan Pharmaceuticals Inc.
- 0378-9045 - Cystagon
Product Characteristics
22 MM
CYSTAGON;150;MYLAN
Product Packages
NDC Code 0378-9045-05
Package Description: 500 CAPSULE in 1 BOTTLE, PLASTIC
Product Details
What is NDC 0378-9045?
What are the uses for Cystagon?
What are Cystagon Active Ingredients?
- CYSTEAMINE BITARTRATE 150 mg/1 - A mercaptoethylamine compound that is endogenously derived from the COENZYME A degradative pathway. The fact that cysteamine is readily transported into LYSOSOMES where it reacts with CYSTINE to form cysteine-cysteamine disulfide and CYSTEINE has led to its use in CYSTINE DEPLETING AGENTS for the treatment of CYSTINOSIS.
Which are Cystagon UNII Codes?
The UNII codes for the active ingredients in this product are:
- CYSTEAMINE BITARTRATE (UNII: QO84GZ3TST)
- CYSTEAMINE (UNII: 5UX2SD1KE2) (Active Moiety)
Which are Cystagon 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:
- AMMONIA (UNII: 5138Q19F1X)
- FERROSOFERRIC OXIDE (UNII: XM0M87F357)
- SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
- CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
- GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
- STARCH, CORN (UNII: O8232NY3SJ)
- PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
- SODIUM LAURYL SULFATE (UNII: 368GB5141J)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
What is the NDC to RxNorm Crosswalk for Cystagon?
- RxCUI: 209788 - Cystagon 150 MG Oral Capsule
- RxCUI: 209788 - cysteamine 150 MG Oral Capsule [Cystagon]
- RxCUI: 209789 - Cystagon 50 MG Oral Capsule
- RxCUI: 209789 - cysteamine 50 MG Oral Capsule [Cystagon]
- RxCUI: 309636 - cysteamine bitartrate 150 MG Oral Capsule
Which are the Pharmacologic Classes for Cystagon?
* Please review the disclaimer below.
[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
[2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.
[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 ("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".