acetaminophen and codeine

Generic: acetaminophen and codeine

Labeler: redpharm drug, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

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

Manufacturer
RedPharm Drug, Inc.

Identifiers & Regulatory

Product NDC 67296-1772
Product ID 67296-1772_3253a2e4-0bc4-4ce7-e063-6294a90a6c51
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040779
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2020-01-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 672961772
Hyphenated Format 67296-1772

Supplemental Identifiers

RxCUI
993781
UPC
0365162033106 0367296177268
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
  • 10 TABLET in 1 BOTTLE (67296-1772-1)
  • 15 TABLET in 1 BOTTLE, PLASTIC (67296-1772-5)
  • 6 TABLET in 1 BOTTLE (67296-1772-6)
source: ndc

Packages (3)

67296-1772-1 10 TABLET in 1 BOTTLE (67296-1772-1) 67296-1772-5 15 TABLET in 1 BOTTLE, PLASTIC (67296-1772-5) 67296-1772-6 6 TABLET in 1 BOTTLE (67296-1772-6)

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": "3253a2e4-0bc4-4ce7-e063-6294a90a6c51", "openfda": {"upc": ["0365162033106", "0367296177268"], "unii": ["362O9ITL9D", "GSL05Y1MN6"], "rxcui": ["993781"], "spl_set_id": ["a35b4ba3-43c0-73c8-e053-2a95a90af5b5"], "manufacturer_name": ["RedPharm Drug, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET in 1 BOTTLE (67296-1772-1)", "package_ndc": "67296-1772-1", "marketing_start_date": "20200101"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE, PLASTIC (67296-1772-5)", "package_ndc": "67296-1772-5", "marketing_start_date": "20200101"}, {"sample": false, "description": "6 TABLET in 1 BOTTLE (67296-1772-6)", "package_ndc": "67296-1772-6", "marketing_start_date": "20200101"}], "brand_name": "Acetaminophen and Codeine", "product_id": "67296-1772_3253a2e4-0bc4-4ce7-e063-6294a90a6c51", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "67296-1772", "dea_schedule": "CIII", "generic_name": "Acetaminophen and Codeine", "labeler_name": "RedPharm Drug, 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": "20200101", "listing_expiration_date": "20261231"}