oxycodone and acetaminophen

Generic: oxycodone and acetaminophen

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxycodone and acetaminophen
Generic Name oxycodone and acetaminophen
Labeler amneal pharmaceuticals of new york llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, oxycodone hydrochloride 5 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 53746-203
Product ID 53746-203_bb27c9aa-111e-4598-8aa6-3073e42d2e3f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040777
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2007-11-27

Pharmacologic Class

Classes
full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53746203
Hyphenated Format 53746-203

Supplemental Identifiers

RxCUI
1049221
UPC
0353746203014
UNII
362O9ITL9D C1ENJ2TE6C

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name oxycodone and acetaminophen (source: ndc)
Generic Name oxycodone and acetaminophen (source: ndc)
Application Number ANDA040777 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (53746-203-01)
  • 500 TABLET in 1 BOTTLE (53746-203-05)
source: ndc

Packages (2)

53746-203-01 100 TABLET in 1 BOTTLE (53746-203-01) 53746-203-05 500 TABLET in 1 BOTTLE (53746-203-05)

Ingredients (2)

acetaminophen (325 mg/1) oxycodone hydrochloride (5 mg/1)

Linked Drug Pages (1)

Oxycodone and Acetaminophen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "bb27c9aa-111e-4598-8aa6-3073e42d2e3f", "openfda": {"upc": ["0353746203014"], "unii": ["362O9ITL9D", "C1ENJ2TE6C"], "rxcui": ["1049221"], "spl_set_id": ["683d563f-0686-4964-8183-cf08758cae71"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (53746-203-01)", "package_ndc": "53746-203-01", "marketing_start_date": "20071127"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (53746-203-05)", "package_ndc": "53746-203-05", "marketing_start_date": "20071127"}], "brand_name": "Oxycodone and Acetaminophen", "product_id": "53746-203_bb27c9aa-111e-4598-8aa6-3073e42d2e3f", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "53746-203", "dea_schedule": "CII", "generic_name": "Oxycodone and Acetaminophen", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxycodone and Acetaminophen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "OXYCODONE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA040777", "marketing_category": "ANDA", "marketing_start_date": "20071127", "listing_expiration_date": "20271231"}