NDC 0406-9202 Fentanyl Citrate
Lozenge Transmucosal - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 0406 - Specgx Llc
- 0406-9202 - Fentanyl Citrate
Product Characteristics
Product Packages
NDC Code 0406-9202-30
Package Description: 30 BLISTER PACK in 1 CARTON / 1 LOZENGE in 1 BLISTER PACK
Price per Unit: $9.64933 per EA
Product Details
What is NDC 0406-9202?
What are the uses for Fentanyl Citrate?
What are Fentanyl Citrate Active Ingredients?
- FENTANYL CITRATE 200 ug/1 - A potent narcotic analgesic, abuse of which leads to habituation or addiction. It is primarily a mu-opioid agonist. Fentanyl is also used as an adjunct to general anesthetics, and as an anesthetic for induction and maintenance. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1078)
Which are Fentanyl Citrate UNII Codes?
The UNII codes for the active ingredients in this product are:
- FENTANYL CITRATE (UNII: MUN5LYG46H)
- FENTANYL (UNII: UF599785JZ) (Active Moiety)
Which are Fentanyl Citrate 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:
- CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
- SUCROSE (UNII: C151H8M554)
- STARCH, CORN (UNII: O8232NY3SJ)
- DEXTRATES (UNII: G263MI44RU)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)
- MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)
- ALCOHOL (UNII: 3K9958V90M)
- WATER (UNII: 059QF0KO0R)
- SHELLAC (UNII: 46N107B71O)
- PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
- FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
- AMMONIA (UNII: 5138Q19F1X)
What is the NDC to RxNorm Crosswalk for Fentanyl Citrate?
- RxCUI: 310293 - fentaNYL citrate 1200 MCG Oral Lozenge
- RxCUI: 310293 - fentanyl 1.2 MG Oral Lozenge
- RxCUI: 310293 - fentanyl (as fentanyl citrate) 1200 MCG Oral Lozenge
- RxCUI: 310294 - fentaNYL citrate 1600 MCG Oral Lozenge
- RxCUI: 310294 - fentanyl 1.6 MG Oral Lozenge
Which are the Pharmacologic Classes for Fentanyl Citrate?
* Please review the disclaimer below.
Patient Education
Fentanyl
Fentanyl is used to treat breakthrough pain (sudden episodes of pain that occur despite round the clock treatment with pain medication) in cancer patients at least 18 years of age (or at least 16 years of age if using Actiq brand lozenges) who are taking regularly scheduled doses of another narcotic (opiate) pain medication, and who are tolerant (used to the effects of the medication) to narcotic pain medications. Fentanyl is in a class of medications called narcotic (opiate) analgesics. It works by changing the way the brain and nervous system respond to pain.
[Learn More]
Pain Relievers
Pain relievers are medicines that reduce or relieve headaches, sore muscles, arthritis, or other aches and pains. There are many different pain medicines, and each one has advantages and risks. Some types of pain respond better to certain medicines than others. Each person may also have a slightly different response to a pain reliever.
Over-the-counter (OTC) medicines are good for many types of pain. There are two main types of OTC pain medicines: acetaminophen (Tylenol) and nonsteroidal anti-inflammatory drugs (NSAIDs). Aspirin, naproxen (Aleve), and ibuprofen (Advil, Motrin) are examples of OTC NSAIDs.
If OTC medicines don't relieve your pain, your doctor may prescribe something stronger. Many NSAIDs are also available at higher prescription doses. The most powerful pain relievers are opioids. They are very effective, but they can sometimes have serious side effects. There is also a risk of addiction. Because of the risks, you must use them only under a doctor's supervision.
There are many things you can do to help ease pain. Pain relievers are just one part of a pain treatment plan.
[Learn More]
* 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.
[7] What is the Drug Enforcement Administration (DEA) CII Schedule? - This is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.
[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.
[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
[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".