acetaminophen and codeine phosphate (68071-4533)

Drug Facts

Product Profile

Brand Name acetaminophen and codeine phosphate

Generic Name acetaminophen and codeine phosphate

Labeler nucare pharmaceuticals,inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

acetaminophen 300 mg/1, codeine phosphate 30 mg/1

Manufacturer

NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-4533

Product ID 68071-4533_2d53b71b-7709-e12d-e063-6294a90a5478

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA040419

DEA Schedule ciii

Listing Expiration 2026-12-31

Marketing Start 2011-07-06

Pharmacologic Class

Classes

full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680714533

Hyphenated Format 68071-4533

Supplemental Identifiers

RxCUI

993781

UPC

0368071453324

UNII

362O9ITL9D GSL05Y1MN6

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 ANDA040419 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

300 mg/1
30 mg/1

source: ndc

Packaging

20 TABLET in 1 BOTTLE (68071-4533-2)
30 TABLET in 1 BOTTLE (68071-4533-3)
24 TABLET in 1 BOTTLE (68071-4533-4)
15 TABLET in 1 BOTTLE (68071-4533-5)
60 TABLET in 1 BOTTLE (68071-4533-6)
84 TABLET in 1 BOTTLE (68071-4533-8)

source: ndc

Packages (6)

68071-4533-2 20 TABLET in 1 BOTTLE (68071-4533-2) 68071-4533-3 30 TABLET in 1 BOTTLE (68071-4533-3) 68071-4533-4 24 TABLET in 1 BOTTLE (68071-4533-4) 68071-4533-5 15 TABLET in 1 BOTTLE (68071-4533-5) 68071-4533-6 60 TABLET in 1 BOTTLE (68071-4533-6) 68071-4533-8 84 TABLET in 1 BOTTLE (68071-4533-8)

Ingredients (2)

acetaminophen (300 mg/1) codeine phosphate (30 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": "2d53b71b-7709-e12d-e063-6294a90a5478", "openfda": {"upc": ["0368071453324"], "unii": ["362O9ITL9D", "GSL05Y1MN6"], "rxcui": ["993781"], "spl_set_id": ["73e2086e-f513-537f-e053-2991aa0a1348"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET in 1 BOTTLE (68071-4533-2)", "package_ndc": "68071-4533-2", "marketing_start_date": "20180820"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68071-4533-3)", "package_ndc": "68071-4533-3", "marketing_start_date": "20180820"}, {"sample": false, "description": "24 TABLET in 1 BOTTLE (68071-4533-4)", "package_ndc": "68071-4533-4", "marketing_start_date": "20180820"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE (68071-4533-5)", "package_ndc": "68071-4533-5", "marketing_start_date": "20180820"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (68071-4533-6)", "package_ndc": "68071-4533-6", "marketing_start_date": "20180820"}, {"sample": false, "description": "84 TABLET in 1 BOTTLE (68071-4533-8)", "package_ndc": "68071-4533-8", "marketing_start_date": "20180820"}], "brand_name": "ACETAMINOPHEN AND CODEINE PHOSPHATE", "product_id": "68071-4533_2d53b71b-7709-e12d-e063-6294a90a5478", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "68071-4533", "dea_schedule": "CIII", "generic_name": "acetaminophen and codeine phosphate", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ACETAMINOPHEN AND CODEINE PHOSPHATE", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "300 mg/1"}, {"name": "CODEINE PHOSPHATE", "strength": "30 mg/1"}], "application_number": "ANDA040419", "marketing_category": "ANDA", "marketing_start_date": "20110706", "listing_expiration_date": "20261231"}