acetaminophen and codeine phosphate

Generic: acetaminophen and codeine phosphate

Labeler: elite laboratories, 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 elite laboratories, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Elite Laboratories, Inc.

Identifiers & Regulatory

Product NDC 64850-643
Product ID 64850-643_d61159a3-cb34-4931-8185-e1eb41654a8a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212418
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2019-09-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64850643
Hyphenated Format 64850-643

Supplemental Identifiers

RxCUI
993770 993781 993890
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 ANDA212418 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
  • 60 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (64850-643-01)
  • 500 TABLET in 1 BOTTLE (64850-643-05)
  • 120 TABLET in 1 BOTTLE (64850-643-12)
source: ndc

Packages (3)

64850-643-01 100 TABLET in 1 BOTTLE (64850-643-01) 64850-643-05 500 TABLET in 1 BOTTLE (64850-643-05) 64850-643-12 120 TABLET in 1 BOTTLE (64850-643-12)

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": "d61159a3-cb34-4931-8185-e1eb41654a8a", "openfda": {"unii": ["362O9ITL9D", "GSL05Y1MN6"], "rxcui": ["993770", "993781", "993890"], "spl_set_id": ["6286e128-1288-4dc0-b14b-f04a0e2a22f9"], "manufacturer_name": ["Elite Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (64850-643-01)", "package_ndc": "64850-643-01", "marketing_start_date": "20240503"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (64850-643-05)", "package_ndc": "64850-643-05", "marketing_start_date": "20250210"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (64850-643-12)", "package_ndc": "64850-643-12", "marketing_start_date": "20190910"}], "brand_name": "Acetaminophen and Codeine Phosphate", "product_id": "64850-643_d61159a3-cb34-4931-8185-e1eb41654a8a", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "64850-643", "dea_schedule": "CIII", "generic_name": "Acetaminophen and Codeine Phosphate", "labeler_name": "Elite Laboratories, 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": "60 mg/1"}], "application_number": "ANDA212418", "marketing_category": "ANDA", "marketing_start_date": "20190910", "listing_expiration_date": "20261231"}