oxycodone and acetaminophen (49999-852)

Drug Facts

Product Profile

Brand Name oxycodone and acetaminophen

Generic Name oxycodone and acetaminophen

Labeler quality care products llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

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

Manufacturer

Quality Care products LLC

Identifiers & Regulatory

Product NDC 49999-852

Product ID 49999-852_f6e0d4da-441b-41e3-8be8-15db3566d3b6

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA087463

DEA Schedule cii

Marketing Start 2010-06-10

Marketing End 2029-02-28

Pharmacologic Class

Classes

full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49999852

Hyphenated Format 49999-852

Supplemental Identifiers

RxCUI

1049221

UNII

362O9ITL9D C1ENJ2TE6C

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 ANDA087463 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

325 mg/1
5 mg/1

source: ndc

Packaging

14 TABLET in 1 BOTTLE, PLASTIC (49999-852-14)
30 TABLET in 1 BOTTLE, PLASTIC (49999-852-30)
60 TABLET in 1 BOTTLE, PLASTIC (49999-852-60)
90 TABLET in 1 BOTTLE, PLASTIC (49999-852-90)

source: ndc

Packages (4)

49999-852-14 14 TABLET in 1 BOTTLE, PLASTIC (49999-852-14) 49999-852-30 30 TABLET in 1 BOTTLE, PLASTIC (49999-852-30) 49999-852-60 60 TABLET in 1 BOTTLE, PLASTIC (49999-852-60) 49999-852-90 90 TABLET in 1 BOTTLE, PLASTIC (49999-852-90)

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": "f6e0d4da-441b-41e3-8be8-15db3566d3b6", "openfda": {"unii": ["362O9ITL9D", "C1ENJ2TE6C"], "rxcui": ["1049221"], "spl_set_id": ["3f2b939c-2206-469b-85a4-b0ee9ba25be8"], "manufacturer_name": ["Quality Care products LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "14 TABLET in 1 BOTTLE, PLASTIC (49999-852-14)", "package_ndc": "49999-852-14", "marketing_end_date": "20270430", "marketing_start_date": "20220810"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (49999-852-30)", "package_ndc": "49999-852-30", "marketing_end_date": "20290228", "marketing_start_date": "20220803"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (49999-852-60)", "package_ndc": "49999-852-60", "marketing_end_date": "20290228", "marketing_start_date": "20220803"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (49999-852-90)", "package_ndc": "49999-852-90", "marketing_end_date": "20290228", "marketing_start_date": "20220803"}], "brand_name": "Oxycodone and Acetaminophen", "product_id": "49999-852_f6e0d4da-441b-41e3-8be8-15db3566d3b6", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "49999-852", "dea_schedule": "CII", "generic_name": "Oxycodone and Acetaminophen", "labeler_name": "Quality Care products 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": "ANDA087463", "marketing_category": "ANDA", "marketing_end_date": "20290228", "marketing_start_date": "20100610"}