acetaminophen and codeine phosphate

Generic: acetaminophen and codeine phosphate

Labeler: preferred pharmaceuticals 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 preferred pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-7835
Product ID 68788-7835_d9c158fb-cdde-46d5-8778-15ec066c4841
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040419
DEA Schedule ciii
Listing Expiration 2027-12-31
Marketing Start 2021-01-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687887835
Hyphenated Format 68788-7835

Supplemental Identifiers

RxCUI
993781
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
  • 15 TABLET in 1 BOTTLE (68788-7835-1)
  • 20 TABLET in 1 BOTTLE (68788-7835-2)
  • 30 TABLET in 1 BOTTLE (68788-7835-3)
  • 60 TABLET in 1 BOTTLE (68788-7835-6)
source: ndc

Packages (4)

68788-7835-1 15 TABLET in 1 BOTTLE (68788-7835-1) 68788-7835-2 20 TABLET in 1 BOTTLE (68788-7835-2) 68788-7835-3 30 TABLET in 1 BOTTLE (68788-7835-3) 68788-7835-6 60 TABLET in 1 BOTTLE (68788-7835-6)

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": "d9c158fb-cdde-46d5-8778-15ec066c4841", "openfda": {"unii": ["362O9ITL9D", "GSL05Y1MN6"], "rxcui": ["993781"], "spl_set_id": ["2453d635-989d-4569-96b3-4efaf61cca71"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET in 1 BOTTLE (68788-7835-1)", "package_ndc": "68788-7835-1", "marketing_start_date": "20210118"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (68788-7835-2)", "package_ndc": "68788-7835-2", "marketing_start_date": "20210118"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68788-7835-3)", "package_ndc": "68788-7835-3", "marketing_start_date": "20210118"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (68788-7835-6)", "package_ndc": "68788-7835-6", "marketing_start_date": "20210118"}], "brand_name": "ACETAMINOPHEN AND CODEINE PHOSPHATE", "product_id": "68788-7835_d9c158fb-cdde-46d5-8778-15ec066c4841", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "68788-7835", "dea_schedule": "CIII", "generic_name": "acetaminophen and codeine phosphate", "labeler_name": "Preferred 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": "20210118", "listing_expiration_date": "20271231"}