NDC 72542-667 Olpruva
Sodium Phenylbutyrate Kit Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
Code Structure Chart
Product Details
What is NDC 72542-667?
What are the uses for Olpruva?
Which are Olpruva UNII Codes?
The UNII codes for the active ingredients in this product are:
- SODIUM PHENYLBUTYRATE (UNII: NT6K61736T)
- PHENYLBUTYRIC ACID (UNII: 7WY7YBI87E) (Active Moiety)
Which are Olpruva 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:
- POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
- SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
- MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
- HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
- TALC (UNII: 7SEV7J4R1U)
- DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)
- STARCH, CORN (UNII: O8232NY3SJ)
What is the NDC to RxNorm Crosswalk for Olpruva?
- RxCUI: 2626369 - sodium phenylbutyrate 2 GM Granules for Oral Suspension
- RxCUI: 2626369 - sodium phenylbutyrate 2000 MG Granules for Oral Suspension
- RxCUI: 2626375 - OLPRUVA 2 GM Granules for Oral Suspension
- RxCUI: 2626375 - sodium phenylbutyrate 2000 MG Granules for Oral Suspension [Olpruva]
- RxCUI: 2626375 - Olpruva 2 GM Granules for Oral Suspension
* 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.
[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".