Oxycodone Hydrochloride
NDC 73780-003

View dosage, usage, ingredients, routes, and UNII mappings.

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Oxycodone Hydrochloride is a NDA AUTHORIZED GENERIC-approved product labeled by Ohemo Life Sciences Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a white product. This product entry covers the primary NDC 73780-003 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
73780-003
Proprietary Name:
Oxycodone Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Code:
73780
FDA Application Number: [6]
NDA209777
Marketing Category: [8]
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.

Marketing Timeline

Start Marketing Date: [9]
07-01-2024
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
I

Product Characteristics

Color(s):
WHITE (C48325 - WHITE)
GREEN (C48329 - GREEN)
Shape:
ROUND (C48348)
Size(s):
11 MM
Imprint(s):
IDT;O;5
IDT;O;15
Score:
1

Code Structure Chart

Product Details

What is NDC 73780-003?

The NDC code 73780-003 is assigned by the FDA to the product Oxycodone Hydrochloride. This pharmaceutical product is labeled by Ohemo Life Sciences Inc. and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 73780-003-10. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

OXYCODONE HYDROCHLORIDE is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated 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:

What is the NDC to RxNorm Crosswalk for this product?

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: 1944529 - oxyCODONE hydrochloride 15 MG Oral Tablet, Abuse-Deterrent
  • RxCUI: 1944529 - Abuse-Deterrent oxycodone hydrochloride 15 MG Oral Tablet
  • RxCUI: 1944529 - oxycodone hydrochloride 15 MG (equivalent to oxycodone 13.4 MG) Oral Tablet, Abuse-Deterrent
  • RxCUI: 1944538 - oxyCODONE hydrochloride 30 MG Oral Tablet, Abuse-Deterrent
  • RxCUI: 1944538 - Abuse-Deterrent oxycodone hydrochloride 30 MG Oral Tablet

* Please review the full disclaimer at the bottom of this page.

Patient Education

Oxycodone


Oxycodone immediate-release tablets, capsules, and oral solution are used to relieve severe, acute pain (pain that begins suddenly, has a specific cause, and is expected to go away when the cause of the pain is healed) in people who are expected to need an opioid pain medication and who cannot be treated with other pain medications. 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 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®, others) and aspirin (Percodan®). 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]


Pain Relievers


What are 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 with 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.

What are the types of over-the-counter pain relievers?

Over-the-counter (OTC) medicines are good for many types of pain. Two types of OTC pain medicines are usually recommended for mild to moderate pain.

  • Acetaminophen (Tylenol) is used in many OTC and prescription medicines. It's often considered safer than other pain relievers. Unfortunately, it's common for people to take too much accidentally. Be careful not to take too much each day or use more than one medicine with acetaminophen. Check with your health care provider before taking medicines containing acetaminophen for more than ten days or five days for your child.
  • Nonsteroidal anti-inflammatory drugs (NSAIDs) include aspirin, naproxen (Aleve), and ibuprofen (Advil, Motrin). These pain relievers are often most effective if you have pain and inflammation (swelling), such as for arthritis or menstrual cramps. If you take more than the recommended amount, NSAIDs may cause nausea, stomach pain, or ulcers.

What are prescription pain relievers?

If OTC pain relievers don't relieve your pain, your provider may prescribe something stronger. Many NSAIDs are also available at higher prescription doses.

The most powerful pain relievers are opioids, sometimes called narcotics. They include strong prescription pain relievers such as oxycodone, hydrocodone, or morphine. Opioids are sometimes used to treat moderate to severe pain. Your provider may give you a prescription to reduce pain after you have had a major injury or surgery.

Opioids 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 your provider's supervision.

What are some non-drug treatments for pain?

Pain relievers are just one part of a pain treatment plan. Environmental factors, stress, and beliefs about pain may affect the way you feel about pain and respond to treatment.

There are many things you can do to help ease pain. Treatment depends on the cause and type of pain. It's important to check with your provider before trying any of them. A few non-drug treatments for pain include:

  • Acupuncture
  • Hot or cold packs
  • Massage therapy
  • Physical therapy
  • Relaxation techniques

[Learn More]


* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".