NDC 0406-0512 Oxycodone And Acetaminophen
Oxycodone Hydrochloride And Acetaminophen Tablet Oral

Product Information

Oxycodone And Acetaminophen is a human prescription drug product labeled by Specgx Llc. The generic name of Oxycodone And Acetaminophen is oxycodone hydrochloride and acetaminophen. The product's dosage form is tablet and is administered via oral form.

Product Code0406-0512
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Oxycodone And Acetaminophen
Non-Proprietary Name 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.
Oxycodone Hydrochloride And Acetaminophen
Product Type 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.
Human Prescription Drug
Dosage FormTablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Specgx Llc
Labeler Code0406
FDA Application Number 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.
ANDA087463
DEA Schedule What is the Drug Enforcement Administration (DEA) CII Schedule?
The controlled substances in the CII schedule have a high abuse potential with severe psychological or physical dependence liability, but have accepted medical use in the United States. Schedule CII controlled substances include certain narcotic, stimulant, and depressant drugs.
Schedule II (CII) Substances
Marketing Category 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.
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
12-07-1983
Listing Expiration Date 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.
12-31-2022
Exclude Flag 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".
N
NDC Code Structure

What are the uses for Oxycodone And Acetaminophen?


Product Characteristics

Color(s)WHITE (C48325)
ShapeROUND (C48348)
Size(s)12 MM
Imprint(s)512
Score2

Product Packages

NDC 0406-0512-01

Package Description: 100 TABLET in 1 BOTTLE

Price per Unit: $0.09235 per EA

NDC 0406-0512-05

Package Description: 500 TABLET in 1 BOTTLE

Price per Unit: $0.09235 per EA

NDC 0406-0512-23

Package Description: 1 TABLET in 1 BLISTER PACK

Price per Unit: $0.09235 per EA

NDC 0406-0512-62

Package Description: 100 TABLET in 1 BLISTER PACK

Price per Unit: $0.09235 per EA

NDC 0406-0512-91

Package Description: 5000 TABLET in 1 PAIL

Price per Unit: $0.15247 per EA

Product Details

What are Oxycodone And Acetaminophen Active Ingredients?

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.
  • ACETAMINOPHEN 325 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.

Oxycodone And Acetaminophen Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1049214 - oxyCODONE 10 MG / acetaminophen 325 MG Oral Tablet
  • RxCUI: 1049214 - acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral Tablet
  • RxCUI: 1049214 - APAP 325 MG / oxycodone hydrochloride 10 MG Oral Tablet
  • RxCUI: 1049221 - oxyCODONE 5 MG / acetaminophen 325 MG Oral Tablet
  • RxCUI: 1049221 - acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral Tablet

Oxycodone And Acetaminophen 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.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Patient Education

Acetaminophen

Acetaminophen is pronounced as (a set a mee' noe fen)

Why is acetaminophen medication prescribed?
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to va...
[Read More]
Oxycodone

Oxycodone is pronounced as (ox i koe' done)
Why is oxycodone medication prescribed?
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 e...
[Read More]

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Oxycodone And Acetaminophen Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

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