acetaminophen and codeine phosphate

Generic: acetaminophen and codeine phosphate

Labeler: genus lifesciences inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen and codeine phosphate
Generic Name acetaminophen and codeine phosphate
Labeler genus lifesciences inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

acetaminophen 120 mg/5mL, codeine phosphate 12 mg/5mL

Manufacturer
Genus Lifesciences Inc.

Identifiers & Regulatory

Product NDC 64950-374
Product ID 64950-374_87cb7b3c-3ed5-4a40-a486-7713bb2b6e3e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA087508
DEA Schedule cv
Listing Expiration 2027-12-31
Marketing Start 2023-08-10

Pharmacologic Class

Classes
full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64950374
Hyphenated Format 64950-374

Supplemental Identifiers

RxCUI
993755
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 ANDA087508 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/5mL
  • 12 mg/5mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE, PLASTIC (64950-374-04)
  • 473 mL in 1 BOTTLE, PLASTIC (64950-374-16)
source: ndc

Packages (2)

64950-374-04 118 mL in 1 BOTTLE, PLASTIC (64950-374-04) 64950-374-16 473 mL in 1 BOTTLE, PLASTIC (64950-374-16)

Ingredients (2)

acetaminophen (120 mg/5mL) codeine phosphate (12 mg/5mL)

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": "87cb7b3c-3ed5-4a40-a486-7713bb2b6e3e", "openfda": {"unii": ["362O9ITL9D", "GSL05Y1MN6"], "rxcui": ["993755"], "spl_set_id": ["95a5d638-3072-4c37-a4cd-f8550328e2c6"], "manufacturer_name": ["Genus Lifesciences Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE, PLASTIC (64950-374-04)", "package_ndc": "64950-374-04", "marketing_start_date": "20230810"}, {"sample": false, "description": "473 mL in 1 BOTTLE, PLASTIC (64950-374-16)", "package_ndc": "64950-374-16", "marketing_start_date": "20230810"}], "brand_name": "Acetaminophen and Codeine Phosphate", "product_id": "64950-374_87cb7b3c-3ed5-4a40-a486-7713bb2b6e3e", "dosage_form": "SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "64950-374", "dea_schedule": "CV", "generic_name": "Acetaminophen and Codeine Phosphate", "labeler_name": "Genus Lifesciences Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acetaminophen and Codeine Phosphate", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "120 mg/5mL"}, {"name": "CODEINE PHOSPHATE", "strength": "12 mg/5mL"}], "application_number": "ANDA087508", "marketing_category": "ANDA", "marketing_start_date": "20230810", "listing_expiration_date": "20271231"}