acetaminophen and codeine phosphate

Generic: acetaminophen and codeine phosphate

Labeler: direct_rx
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 direct_rx
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-376
Product ID 72189-376_2c4cbd73-cdae-14f5-e063-6294a90ab38e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040419
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2022-08-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189376
Hyphenated Format 72189-376

Supplemental Identifiers

RxCUI
993890
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
  • 60 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (72189-376-60)
source: ndc

Packages (1)

72189-376-60 60 TABLET in 1 BOTTLE (72189-376-60)

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": "2c4cbd73-cdae-14f5-e063-6294a90ab38e", "openfda": {"unii": ["362O9ITL9D", "GSL05Y1MN6"], "rxcui": ["993890"], "spl_set_id": ["e78e50c0-36da-528e-e053-2995a90a3d80"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (72189-376-60)", "package_ndc": "72189-376-60", "marketing_start_date": "20220831"}], "brand_name": "Acetaminophen and Codeine Phosphate", "product_id": "72189-376_2c4cbd73-cdae-14f5-e063-6294a90ab38e", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "72189-376", "dea_schedule": "CIII", "generic_name": "Acetaminophen and Codeine Phosphate", "labeler_name": "Direct_Rx", "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": "ANDA040419", "marketing_category": "ANDA", "marketing_start_date": "20220831", "listing_expiration_date": "20261231"}