acetaminophen and codeine

Generic: acetaminophen and codeine

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen and codeine
Generic Name acetaminophen and codeine
Labeler amneal pharmaceuticals llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-033
Product ID 65162-033_75a6d334-42b8-44d0-a4a1-fd3eeb95008f
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 65162033
Hyphenated Format 65162-033

Supplemental Identifiers

RxCUI
993781
UPC
0365162033106
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 (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
  • 100 TABLET in 1 BOTTLE (65162-033-10)
  • 1000 TABLET in 1 BOTTLE (65162-033-11)
  • 500 TABLET in 1 BOTTLE (65162-033-50)
source: ndc

Packages (3)

65162-033-10 100 TABLET in 1 BOTTLE (65162-033-10) 65162-033-11 1000 TABLET in 1 BOTTLE (65162-033-11) 65162-033-50 500 TABLET in 1 BOTTLE (65162-033-50)

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": "75a6d334-42b8-44d0-a4a1-fd3eeb95008f", "openfda": {"upc": ["0365162033106"], "unii": ["362O9ITL9D", "GSL05Y1MN6"], "rxcui": ["993781"], "spl_set_id": ["8bc4108b-314e-4a52-a37c-631c6b869b04"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (65162-033-10)", "package_ndc": "65162-033-10", "marketing_start_date": "20080529"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (65162-033-11)", "package_ndc": "65162-033-11", "marketing_start_date": "20080529"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (65162-033-50)", "package_ndc": "65162-033-50", "marketing_start_date": "20080529"}], "brand_name": "Acetaminophen and Codeine", "product_id": "65162-033_75a6d334-42b8-44d0-a4a1-fd3eeb95008f", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "65162-033", "dea_schedule": "CIII", "generic_name": "Acetaminophen and Codeine", "labeler_name": "Amneal Pharmaceuticals LLC", "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"}