NDC 72245-681 Prolate
Oxycodone And Acetaminophen Tablet Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 72245 - Forte Bio-pharma Llc
- 72245-681 - Prolate
Product Characteristics
Product Packages
NDC Code 72245-681-03
Package Description: 30 TABLET in 1 BOTTLE, PLASTIC
NDC Code 72245-681-10
Package Description: 100 TABLET in 1 BOTTLE, PLASTIC
Product Details
What is NDC 72245-681?
What are the uses for Prolate?
What are Prolate Active Ingredients?
- ACETAMINOPHEN 300 mg/1 - Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.
- OXYCODONE HYDROCHLORIDE 5 mg/1 - A semisynthetic derivative of CODEINE.
Which are Prolate UNII Codes?
The UNII codes for the active ingredients in this product are:
- OXYCODONE HYDROCHLORIDE (UNII: C1ENJ2TE6C)
- OXYCODONE (UNII: CD35PMG570) (Active Moiety)
- ACETAMINOPHEN (UNII: 362O9ITL9D)
- ACETAMINOPHEN (UNII: 362O9ITL9D) (Active Moiety)
Which are Prolate 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:
- SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
- CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
- CROSPOVIDONE (UNII: 68401960MK)
- D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
- CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
- POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
- STARCH, CORN (UNII: O8232NY3SJ)
- STEARIC ACID (UNII: 4ELV7Z65AP)
What is the NDC to RxNorm Crosswalk for Prolate?
- RxCUI: 1014599 - oxyCODONE HCl 10 MG / acetaminophen 300 MG Oral Tablet
- RxCUI: 1014599 - acetaminophen 300 MG / oxycodone hydrochloride 10 MG Oral Tablet
- RxCUI: 1014599 - APAP 300 MG / oxycodone hydrochloride 10 MG Oral Tablet
- RxCUI: 1014615 - oxyCODONE HCl 5 MG / acetaminophen 300 MG Oral Tablet
- RxCUI: 1014615 - acetaminophen 300 MG / oxycodone hydrochloride 5 MG Oral Tablet
Which are the Pharmacologic Classes for Prolate?
* Please review the disclaimer below.
Patient Education
Acetaminophen
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
[Learn More]
Oxycodone
Oxycodone is used to relieve moderate to severe pain. Oxycodone extended-release tablets and extended-release capsules are used to relieve severe pain in people who are expected to need pain medication around the clock for a long time and who cannot be treated with other medications. Oxycodone extended-release tablets and extended-release capsules should not be used to treat pain that can be controlled by medication that is taken as needed. Oxycodone extended-release tablets, extended-release capsules, and concentrated solution should only be used to treat people who are tolerant (used to the effects of the medication) to opioid medications because they have taken this type of medication for at least one week. Oxycodone is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain. Oxycodone is also available in combination with acetaminophen (Oxycet, Percocet, Roxicet, Xartemis XR, others); aspirin (Percodan); and ibuprofen. This monograph only includes information about the use of oxycodone alone. If you are taking an oxycodone combination product, be sure to read information about all the ingredients in the product you are taking and ask your doctor or pharmacist for more information.
[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.
[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".