NDC 25021-467 Octreotide Acetate
Injection, Solution Intravenous; Subcutaneous - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 25021 - Sagent Pharmaceuticals
- 25021-467 - Octreotide Acetate
Product Packages
NDC Code 25021-467-05
Package Description: 1 VIAL in 1 CARTON / 5 mL in 1 VIAL
Product Details
What is NDC 25021-467?
What are the uses for Octreotide Acetate?
What are Octreotide Acetate Active Ingredients?
Which are Octreotide Acetate UNII Codes?
The UNII codes for the active ingredients in this product are:
- OCTREOTIDE ACETATE (UNII: 75R0U2568I)
- OCTREOTIDE (UNII: RWM8CCW8GP) (Active Moiety)
Which are Octreotide Acetate 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:
- SODIUM CHLORIDE (UNII: 451W47IQ8X)
- SODIUM ACETATE (UNII: 4550K0SC9B)
- ACETIC ACID (UNII: Q40Q9N063P)
- WATER (UNII: 059QF0KO0R)
- PHENOL (UNII: 339NCG44TV)
What is the NDC to RxNorm Crosswalk for Octreotide Acetate?
- RxCUI: 312068 - octreotide 50 MCG in 1 ML Injection
- RxCUI: 312068 - 1 ML octreotide 0.05 MG/ML Injection
- RxCUI: 312068 - octreotide 50 MCG per 1 ML Injection
- RxCUI: 312069 - octreotide 100 MCG in 1 ML Injection
- RxCUI: 312069 - 1 ML octreotide 0.1 MG/ML Injection
Which are the Pharmacologic Classes for Octreotide Acetate?
* Please review the disclaimer below.
Patient Education
Octreotide Injection
Octreotide immediate-release injection is used to decrease the amount of growth hormone (a natural substance) produced by people with acromegaly (condition in which the body produces too much growth hormone, causing enlargement of the hands, feet, and facial features; joint pain; and other symptoms) who cannot be treated with surgery, radiation, or another medication. Octreotide immediate-release injection is also used to control diarrhea and flushing caused by carcinoid tumors (slow-growing tumors that release natural substances that can cause symptoms) and vasoactive intestinal peptide secreting adenomas (VIP-omas; tumors that form in the pancreas and release natural substances that can cause symptoms). Octreotide long-acting injection is used to control acromegaly, carcinoid tumors, and VIP-omas in people who have been successfully treated with octreotide injection but prefer to receive injections less often. Octreotide injection is in a class of medications called octapeptides. It works by decreasing the amounts of certain natural substances produced by the body.
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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.
[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".