acetaminophen and codeine phosphate (64380-447)

Drug Facts

Product Profile

Brand Name acetaminophen and codeine phosphate

Generic Name acetaminophen and codeine phosphate

Labeler strides pharma science limited

Dosage Form TABLET

Routes

ORAL

Active Ingredients

acetaminophen 300 mg/1, codeine phosphate 60 mg/1

Manufacturer

Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-447

Product ID 64380-447_c87671eb-3ec7-4930-be25-5686a75679de

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA089828

DEA Schedule ciii

Listing Expiration 2026-12-31

Marketing Start 2024-05-20

Pharmacologic Class

Classes

full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64380447

Hyphenated Format 64380-447

Supplemental Identifiers

RxCUI

993770 993781 993890

UPC

0364380448013 0364380446019 0364380447016

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 ANDA089828 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

300 mg/1
60 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE (64380-447-01)
500 TABLET in 1 BOTTLE (64380-447-02)

source: ndc

Packages (2)

64380-447-01 100 TABLET in 1 BOTTLE (64380-447-01) 64380-447-02 500 TABLET in 1 BOTTLE (64380-447-02)

Ingredients (2)

acetaminophen (300 mg/1) codeine phosphate (60 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": "c87671eb-3ec7-4930-be25-5686a75679de", "openfda": {"upc": ["0364380448013", "0364380446019", "0364380447016"], "unii": ["362O9ITL9D", "GSL05Y1MN6"], "rxcui": ["993770", "993781", "993890"], "spl_set_id": ["c459ed02-afd6-4533-82b6-bfb2c7ab0e72"], "manufacturer_name": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (64380-447-01)", "package_ndc": "64380-447-01", "marketing_start_date": "20240520"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (64380-447-02)", "package_ndc": "64380-447-02", "marketing_start_date": "20240520"}], "brand_name": "Acetaminophen and Codeine Phosphate", "product_id": "64380-447_c87671eb-3ec7-4930-be25-5686a75679de", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "64380-447", "dea_schedule": "CIII", "generic_name": "Acetaminophen and Codeine Phosphate", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acetaminophen and Codeine Phosphate", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "300 mg/1"}, {"name": "CODEINE PHOSPHATE", "strength": "60 mg/1"}], "application_number": "ANDA089828", "marketing_category": "ANDA", "marketing_start_date": "20240520", "listing_expiration_date": "20261231"}