oxycodone and acetaminophen

Generic: oxycodone and acetaminophen

Labeler: granules pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxycodone and acetaminophen
Generic Name oxycodone and acetaminophen
Labeler granules pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Granules Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 70010-668
Product ID 70010-668_4221a53d-0185-7219-e063-6394a90a7ff7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211708
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2022-01-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70010668
Hyphenated Format 70010-668

Supplemental Identifiers

RxCUI
1049214 1049221 1049225 1049635
UNII
C1ENJ2TE6C 362O9ITL9D

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 ANDA211708 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (70010-668-01)
  • 500 TABLET in 1 BOTTLE (70010-668-05)
source: ndc

Packages (2)

70010-668-01 100 TABLET in 1 BOTTLE (70010-668-01) 70010-668-05 500 TABLET in 1 BOTTLE (70010-668-05)

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": "4221a53d-0185-7219-e063-6394a90a7ff7", "openfda": {"unii": ["C1ENJ2TE6C", "362O9ITL9D"], "rxcui": ["1049214", "1049221", "1049225", "1049635"], "spl_set_id": ["cc966d57-7cdc-4de3-bbcf-718e2fce9cb7"], "manufacturer_name": ["Granules Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (70010-668-01)", "package_ndc": "70010-668-01", "marketing_start_date": "20220101"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (70010-668-05)", "package_ndc": "70010-668-05", "marketing_start_date": "20220101"}], "brand_name": "Oxycodone and Acetaminophen", "product_id": "70010-668_4221a53d-0185-7219-e063-6394a90a7ff7", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "70010-668", "dea_schedule": "CII", "generic_name": "Oxycodone and Acetaminophen", "labeler_name": "Granules Pharmaceuticals Inc.", "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": "ANDA211708", "marketing_category": "ANDA", "marketing_start_date": "20220101", "listing_expiration_date": "20261231"}