NDC 45802-929 Mesalamine
Kit - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 45802 - Padagis Israel Pharmaceuticals Ltd
- 45802-929 - Mesalamine
Product Characteristics
Product Packages
NDC Code 45802-929-49
Package Description: 4 CARTON in 1 KIT / 1 KIT in 1 CARTON * 60 mL in 1 BOTTLE (45802-098-46) * 1 SWAB in 1 PACKET
Price per Unit: $116.13200 per EA
Product Details
What is NDC 45802-929?
What are the uses for Mesalamine?
Which are Mesalamine UNII Codes?
The UNII codes for the active ingredients in this product are:
- MESALAMINE (UNII: 4Q81I59GXC)
- MESALAMINE (UNII: 4Q81I59GXC) (Active Moiety)
Which are Mesalamine 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:
- CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)
- EDETATE DISODIUM (UNII: 7FLD91C86K)
- POTASSIUM ACETATE (UNII: M911911U02)
- POTASSIUM METABISULFITE (UNII: 65OE787Q7W)
- WATER (UNII: 059QF0KO0R)
- XANTHAN GUM (UNII: TTV12P4NEE)
- SODIUM BENZOATE (UNII: OJ245FE5EU)
- BENZOIC ACID (UNII: 8SKN0B0MIM)
- LEVOMENOL (UNII: 24WE03BX2T)
- BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
- BUTYLPARABEN (UNII: 3QPI1U3FV8)
- CARAMEL (UNII: T9D99G2B1R)
- DEHYDROACETIC ACID (UNII: 2KAG279R6R)
- DEXPANTHENOL (UNII: 1O6C93RI7Z)
- DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
- ETHYLPARABEN (UNII: 14255EXE39)
- DEXTROSE (UNII: IY9XDZ35W2)
- ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
- LACTIC ACID (UNII: 33X04XA5AT)
- METHYLPARABEN (UNII: A2I8C7HI9T)
- PHENOXYETHANOL (UNII: HIE492ZZ3T)
- POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
- PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
- PROPYLPARABEN (UNII: Z8IX2SC1OH)
What is the NDC to RxNorm Crosswalk for Mesalamine?
- RxCUI: 238151 - mesalamine 4 GM per 60 mL Enema
- RxCUI: 238151 - mesalamine 66.7 MG/ML Enema
- RxCUI: 238151 - mesalamine 4 GM per 60 ML Enema
- RxCUI: 238151 - mesalazine 66.7 MG/ML Enema
* Please review the disclaimer below.
Patient Education
Mesalamine Rectal
Rectal mesalamine is used to treat ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum), proctitis (swelling in the rectum), and proctosigmoiditis (swelling in the rectum and sigmoid colon [last section of the colon]). Rectal mesalamine is in a class of medications called anti-inflammatory agents. It works by stopping the body from producing a certain substance that may cause inflammation.
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* 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.
[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".