oxycodone and acetaminophen (70010-670)

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 10 mg/1

Manufacturer

Granules Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 70010-670

Product ID 70010-670_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 70010670

Hyphenated Format 70010-670

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
10 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE (70010-670-01)
500 TABLET in 1 BOTTLE (70010-670-05)

source: ndc

Packages (2)

70010-670-01 100 TABLET in 1 BOTTLE (70010-670-01) 70010-670-05 500 TABLET in 1 BOTTLE (70010-670-05)

Ingredients (2)

acetaminophen (325 mg/1) oxycodone hydrochloride (10 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 (70010-670-01)", "package_ndc": "70010-670-01", "marketing_start_date": "20220101"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (70010-670-05)", "package_ndc": "70010-670-05", "marketing_start_date": "20220101"}], "brand_name": "Oxycodone and Acetaminophen", "product_id": "70010-670_4221a53d-0185-7219-e063-6394a90a7ff7", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "70010-670", "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": "10 mg/1"}], "application_number": "ANDA211708", "marketing_category": "ANDA", "marketing_start_date": "20220101", "listing_expiration_date": "20261231"}