acetaminophen and codeine

Generic: acetaminophen and codeine

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen and codeine
Generic Name acetaminophen and codeine
Labeler direct_rx
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 61919-484
Product ID 61919-484_2e805755-8d3f-0e94-e063-6294a90a7bc5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040419
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2019-07-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61919484
Hyphenated Format 61919-484

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 ANDA040419 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
  • 30 mg/1
source: ndc
Packaging
  • 10 TABLET in 1 BOTTLE (61919-484-10)
  • 18 TABLET in 1 BOTTLE (61919-484-18)
  • 30 TABLET in 1 BOTTLE (61919-484-30)
  • 100 TABLET in 1 BOTTLE (61919-484-71)
source: ndc

Packages (4)

61919-484-10 10 TABLET in 1 BOTTLE (61919-484-10) 61919-484-18 18 TABLET in 1 BOTTLE (61919-484-18) 61919-484-30 30 TABLET in 1 BOTTLE (61919-484-30) 61919-484-71 100 TABLET in 1 BOTTLE (61919-484-71)

Ingredients (2)

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

Linked Drug Pages (2)

ACETAMINOPHEN AND CODEINE ndc-match (0.9) ACETAMINOPHEN AND CODEINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2e805755-8d3f-0e94-e063-6294a90a7bc5", "openfda": {"unii": ["362O9ITL9D", "GSL05Y1MN6"], "rxcui": ["993781"], "spl_set_id": ["8d7d6fa4-cc9f-6b4b-e053-2995a90a7286"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET in 1 BOTTLE (61919-484-10)", "package_ndc": "61919-484-10", "marketing_start_date": "20190712"}, {"sample": false, "description": "18 TABLET in 1 BOTTLE (61919-484-18)", "package_ndc": "61919-484-18", "marketing_start_date": "20190712"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (61919-484-30)", "package_ndc": "61919-484-30", "marketing_start_date": "20190712"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (61919-484-71)", "package_ndc": "61919-484-71", "marketing_start_date": "20190712"}], "brand_name": "ACETAMINOPHEN AND CODEINE", "product_id": "61919-484_2e805755-8d3f-0e94-e063-6294a90a7bc5", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "61919-484", "dea_schedule": "CIII", "generic_name": "ACETAMINOPHEN AND CODEINE", "labeler_name": "Direct_Rx", "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": "ANDA040419", "marketing_category": "ANDA", "marketing_start_date": "20190712", "listing_expiration_date": "20261231"}