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NDC 00121-0827-04 OXYCODONE HYDROCHLORIDE 5 mg/5mL Details
OXYCODONE HYDROCHLORIDE 5 mg/5mL
OXYCODONE HYDROCHLORIDE is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by PAI Holdings, LLC. The primary component is OXYCODONE HYDROCHLORIDE.
MedlinePlus Drug Summary
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.
Related Packages: 00121-0827-04Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Oxycodone
Product Information
| NDC | 00121-0827 |
|---|---|
| Product ID | 0121-0827_81862aa3-6834-4ba9-affd-6376b10be351 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | OXYCODONE HYDROCHLORIDE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | OXYCODONE HYDROCHLORIDE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/5mL |
| Substance Name | OXYCODONE HYDROCHLORIDE |
| Labeler Name | PAI Holdings, LLC |
| Pharmaceutical Class | Full Opioid Agonists [MoA], Opioid Agonist [EPC] |
| DEA Schedule | CII |
| Marketing Category | ANDA |
| Application Number | ANDA206914 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00121-0827-04 (00121082704)
| NDC Package Code | 0121-0827-04 |
|---|---|
| Billing NDC | 00121082704 |
| Package | 118 mL in 1 BOTTLE (0121-0827-04) |
| Marketing Start Date | 2019-04-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |