oxycodone and acetaminophen

Generic: oxycodone and acetaminophen

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxycodone and acetaminophen
Generic Name oxycodone and acetaminophen
Labeler avpak
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, oxycodone hydrochloride 7.5 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-645
Product ID 50268-645_48ec761b-a7bc-59ef-e063-6294a90a579b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040778
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2018-07-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268645
Hyphenated Format 50268-645

Supplemental Identifiers

RxCUI
1049214 1049221 1049225
UNII
C1ENJ2TE6C 362O9ITL9D

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 ANDA040778 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 7.5 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-645-15) / 1 TABLET in 1 BLISTER PACK (50268-645-11)
source: ndc

Packages (1)

50268-645-15 50 BLISTER PACK in 1 BOX (50268-645-15) / 1 TABLET in 1 BLISTER PACK (50268-645-11)

Ingredients (2)

acetaminophen (325 mg/1) oxycodone hydrochloride (7.5 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": "48ec761b-a7bc-59ef-e063-6294a90a579b", "openfda": {"unii": ["C1ENJ2TE6C", "362O9ITL9D"], "rxcui": ["1049214", "1049221", "1049225"], "spl_set_id": ["7055acd5-1cbb-397e-e053-2a91aa0a3852"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-645-15)  / 1 TABLET in 1 BLISTER PACK (50268-645-11)", "package_ndc": "50268-645-15", "marketing_start_date": "20180709"}], "brand_name": "Oxycodone and Acetaminophen", "product_id": "50268-645_48ec761b-a7bc-59ef-e063-6294a90a579b", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "50268-645", "dea_schedule": "CII", "generic_name": "Oxycodone and Acetaminophen", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxycodone and Acetaminophen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "OXYCODONE HYDROCHLORIDE", "strength": "7.5 mg/1"}], "application_number": "ANDA040778", "marketing_category": "ANDA", "marketing_start_date": "20180709", "listing_expiration_date": "20271231"}