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NDC 53746-0203-05 Oxycodone and Acetaminophen 325; 5 mg/1; mg/1 Details
Oxycodone and Acetaminophen 325; 5 mg/1; mg/1
Oxycodone and Acetaminophen is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals of New York LLC. The primary component is ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE.
MedlinePlus Drug Summary
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.
Related Packages: 53746-0203-05Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen
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: 53746-0203-05Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Oxycodone
Product Information
| NDC | 53746-0203 |
|---|---|
| Product ID | 53746-203_f0455ca8-9653-4936-a262-c5c880323fa4 |
| Associated GPIs | 65990002200310 |
| GCN Sequence Number | 004222 |
| GCN Sequence Number Description | oxycodone HCl/acetaminophen TABLET 5 MG-325MG ORAL |
| HIC3 | H3U |
| HIC3 Description | OPIOID ANALGESIC AND NON-SALICYLATE ANALGESICS |
| GCN | 70491 |
| HICL Sequence Number | 001741 |
| HICL Sequence Number Description | OXYCODONE HCL/ACETAMINOPHEN |
| Brand/Generic | Generic |
| Proprietary Name | Oxycodone and Acetaminophen |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Oxycodone and Acetaminophen |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 325; 5 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
| Labeler Name | Amneal Pharmaceuticals of New York LLC |
| Pharmaceutical Class | Full Opioid Agonists [MoA], Opioid Agonist [EPC] |
| DEA Schedule | CII |
| Marketing Category | ANDA |
| Application Number | ANDA040777 |
| Listing Certified Through | 2023-12-31 |
Package
NDC 53746-0203-05 (53746020305)
| NDC Package Code | 53746-203-05 |
|---|---|
| Billing NDC | 53746020305 |
| Package | 500 TABLET in 1 BOTTLE (53746-203-05) |
| Marketing Start Date | 2007-11-27 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.10538 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | OXYCODONE-ACETAMINOPHEN 5-325 MG TAB |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |