oxycodone and acetaminophen (71205-347)

Drug Facts

Product Profile

Brand Name oxycodone and acetaminophen

Generic Name oxycodone and acetaminophen

Labeler proficient rx lp

Dosage Form TABLET

Routes

ORAL

Active Ingredients

acetaminophen 325 mg/1, oxycodone hydrochloride 10 mg/1

Manufacturer

Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-347

Product ID 71205-347_b53c68fe-b3a3-4a62-b75b-cb831ef1a81f

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA207419

DEA Schedule cii

Listing Expiration 2026-12-31

Marketing Start 2017-04-11

Pharmacologic Class

Classes

full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71205347

Hyphenated Format 71205-347

Supplemental Identifiers

RxCUI

1049214

UPC

0371205347604

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 ANDA207419 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

325 mg/1
10 mg/1

source: ndc

Packaging

12 TABLET in 1 BOTTLE (71205-347-12)
15 TABLET in 1 BOTTLE (71205-347-15)
20 TABLET in 1 BOTTLE (71205-347-20)
30 TABLET in 1 BOTTLE (71205-347-30)
60 TABLET in 1 BOTTLE (71205-347-60)
90 TABLET in 1 BOTTLE (71205-347-90)

source: ndc

Packages (6)

71205-347-12 12 TABLET in 1 BOTTLE (71205-347-12) 71205-347-15 15 TABLET in 1 BOTTLE (71205-347-15) 71205-347-20 20 TABLET in 1 BOTTLE (71205-347-20) 71205-347-30 30 TABLET in 1 BOTTLE (71205-347-30) 71205-347-60 60 TABLET in 1 BOTTLE (71205-347-60) 71205-347-90 90 TABLET in 1 BOTTLE (71205-347-90)

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": "b53c68fe-b3a3-4a62-b75b-cb831ef1a81f", "openfda": {"upc": ["0371205347604"], "unii": ["362O9ITL9D", "C1ENJ2TE6C"], "rxcui": ["1049214"], "spl_set_id": ["5df7c033-0f31-45bc-8c34-3da45635e66d"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "12 TABLET in 1 BOTTLE (71205-347-12)", "package_ndc": "71205-347-12", "marketing_start_date": "20191101"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE (71205-347-15)", "package_ndc": "71205-347-15", "marketing_start_date": "20191101"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (71205-347-20)", "package_ndc": "71205-347-20", "marketing_start_date": "20191101"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (71205-347-30)", "package_ndc": "71205-347-30", "marketing_start_date": "20191101"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71205-347-60)", "package_ndc": "71205-347-60", "marketing_start_date": "20191101"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71205-347-90)", "package_ndc": "71205-347-90", "marketing_start_date": "20191101"}], "brand_name": "Oxycodone and Acetaminophen", "product_id": "71205-347_b53c68fe-b3a3-4a62-b75b-cb831ef1a81f", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "71205-347", "dea_schedule": "CII", "generic_name": "Oxycodone and Acetaminophen", "labeler_name": "Proficient Rx LP", "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": "ANDA207419", "marketing_category": "ANDA", "marketing_start_date": "20170411", "listing_expiration_date": "20261231"}