NDC 0115-1317 Oxymorphone Hydrochloride
Tablet, Film Coated, Extended Release Oral

Product Information

Product Code0115-1317
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.
Oxymorphone Hydrochloride
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.
Oxymorphone Hydrochloride
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, Film Coated, Extended Release - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
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.
Amneal Pharmaceuticals Of New York Llc
Labeler Code0115
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.
ANDA079087
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.
01-02-2013
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.
12-31-2023
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

Usage Information


Product Characteristics

Color(s)PURPLE (C48327)
GRAY (C48324)
ORANGE (C48331)
WHITE (C48325)
GREEN (C48329)
BROWN (C48332)
ShapeROUND (C48348)
Size(s)5 MM
Imprint(s)G71
G75
G72
G76
G73
G77
Score1

Product Packages

NDC 0115-1317-01

Package Description: 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

Price per Unit: $11.90819 per EA

NDC 0115-1317-03

Package Description: 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

NDC 0115-1317-08

Package Description: 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

NDC 0115-1317-13

Package Description: 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

Price per Unit: $11.90819 per EA

Product Details

Oxymorphone Hydrochloride is a human prescription drug product labeled by Amneal Pharmaceuticals Of New York Llc. The product's dosage form is tablet, film coated, extended release and is administered via oral form.


What are Oxymorphone Hydrochloride Active Ingredients?

The following is the list of active ingredients in this product. 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.


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:


Inactive Ingredient(s)

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.

  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • D&C RED NO. 27 (UNII: 2LRS185U6K)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)


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

Oxymorphone

Oxymorphone is pronounced as (ox' i mor fone )

Why is oxymorphone medication prescribed?
Oxymorphone is used to relieve moderate to severe pain. Oxymorphone extended-release tablets are used to relieve severe pain in people who are expected to need pain medic...
[Read More]

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Oxymorphone Hydrochloride 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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