acetaminophen and codeine

Generic: acetaminophen and codeine

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen and codeine
Generic Name acetaminophen and codeine
Labeler asclemed usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-103
Product ID 76420-103_b2dde53b-af58-ce44-e053-2a95a90a8fe0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040779
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2008-05-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420103
Hyphenated Format 76420-103

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 (source: ndc)
Generic Name acetaminophen and codeine (source: ndc)
Application Number ANDA040779 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
  • 30 mg/1
source: ndc
Packaging
  • 3 TABLET in 1 BOTTLE (76420-103-03)
  • 10 TABLET in 1 BOTTLE (76420-103-10)
  • 20 TABLET in 1 BOTTLE (76420-103-20)
  • 30 TABLET in 1 BOTTLE (76420-103-30)
source: ndc

Packages (4)

76420-103-03 3 TABLET in 1 BOTTLE (76420-103-03) 76420-103-10 10 TABLET in 1 BOTTLE (76420-103-10) 76420-103-20 20 TABLET in 1 BOTTLE (76420-103-20) 76420-103-30 30 TABLET in 1 BOTTLE (76420-103-30)

Ingredients (2)

acetaminophen (300 mg/1) codeine phosphate (30 mg/1)

Linked Drug Pages (1)

Acetaminophen and Codeine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b2dde53b-af58-ce44-e053-2a95a90a8fe0", "openfda": {"unii": ["362O9ITL9D", "GSL05Y1MN6"], "rxcui": ["993781"], "spl_set_id": ["3f83ba75-9415-4ace-9416-04d666c005a2"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "3 TABLET in 1 BOTTLE (76420-103-03)", "package_ndc": "76420-103-03", "marketing_start_date": "20201030"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE (76420-103-10)", "package_ndc": "76420-103-10", "marketing_start_date": "20201030"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (76420-103-20)", "package_ndc": "76420-103-20", "marketing_start_date": "20201030"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (76420-103-30)", "package_ndc": "76420-103-30", "marketing_start_date": "20201030"}], "brand_name": "Acetaminophen and Codeine", "product_id": "76420-103_b2dde53b-af58-ce44-e053-2a95a90a8fe0", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "76420-103", "dea_schedule": "CIII", "generic_name": "Acetaminophen and Codeine", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acetaminophen and Codeine", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "300 mg/1"}, {"name": "CODEINE PHOSPHATE", "strength": "30 mg/1"}], "application_number": "ANDA040779", "marketing_category": "ANDA", "marketing_start_date": "20080529", "listing_expiration_date": "20261231"}