acetaminophen and codeine phosphate (13107-058)

Drug Facts

Product Profile

Brand Name acetaminophen and codeine phosphate

Generic Name acetaminophen and codeine phosphate

Labeler aurolife pharma, llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

acetaminophen 300 mg/1, codeine phosphate 15 mg/1

Manufacturer

Aurolife Pharma, LLC

Identifiers & Regulatory

Product NDC 13107-058

Product ID 13107-058_d0765823-c018-4aae-85e9-27288fe43950

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA202800

DEA Schedule ciii

Listing Expiration 2026-12-31

Marketing Start 2013-04-15

Pharmacologic Class

Classes

full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 13107058

Hyphenated Format 13107-058

Supplemental Identifiers

RxCUI

993770 993781 993890

UPC

0313107058011

UNII

362O9ITL9D GSL05Y1MN6

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 acetaminophen and codeine phosphate (source: ndc)

Generic Name acetaminophen and codeine phosphate (source: ndc)

Application Number ANDA202800 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

300 mg/1
15 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE (13107-058-01)
500 TABLET in 1 BOTTLE (13107-058-05)
30 TABLET in 1 BOTTLE (13107-058-30)
1000 TABLET in 1 BOTTLE (13107-058-99)

source: ndc

Packages (4)

13107-058-01 100 TABLET in 1 BOTTLE (13107-058-01) 13107-058-05 500 TABLET in 1 BOTTLE (13107-058-05) 13107-058-30 30 TABLET in 1 BOTTLE (13107-058-30) 13107-058-99 1000 TABLET in 1 BOTTLE (13107-058-99)

Ingredients (2)

acetaminophen (300 mg/1) codeine phosphate (15 mg/1)

Linked Drug Pages (1)

Acetaminophen and Codeine Phosphate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "d0765823-c018-4aae-85e9-27288fe43950", "openfda": {"upc": ["0313107058011"], "unii": ["362O9ITL9D", "GSL05Y1MN6"], "rxcui": ["993770", "993781", "993890"], "spl_set_id": ["02386806-02d4-47e3-9c8b-7810146ee795"], "manufacturer_name": ["Aurolife Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (13107-058-01)", "package_ndc": "13107-058-01", "marketing_start_date": "20130415"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (13107-058-05)", "package_ndc": "13107-058-05", "marketing_start_date": "20130415"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (13107-058-30)", "package_ndc": "13107-058-30", "marketing_start_date": "20130415"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (13107-058-99)", "package_ndc": "13107-058-99", "marketing_start_date": "20130415"}], "brand_name": "Acetaminophen and Codeine Phosphate", "product_id": "13107-058_d0765823-c018-4aae-85e9-27288fe43950", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "13107-058", "dea_schedule": "CIII", "generic_name": "Acetaminophen and Codeine Phosphate", "labeler_name": "Aurolife Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acetaminophen and Codeine Phosphate", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "300 mg/1"}, {"name": "CODEINE PHOSPHATE", "strength": "15 mg/1"}], "application_number": "ANDA202800", "marketing_category": "ANDA", "marketing_start_date": "20130415", "listing_expiration_date": "20261231"}