acetaminophen and codeine phosphate

Generic: acetaminophen and codeine phosphate

Labeler: nucare pharmaceuticals, 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 nucare pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
NuCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68071-3658
Product ID 68071-3658_2baebda6-c349-721c-e063-6394a90a3552
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211610
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2019-08-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680713658
Hyphenated Format 68071-3658

Supplemental Identifiers

RxCUI
993781
UPC
0368071365856
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 phosphate (source: ndc)
Generic Name acetaminophen and codeine phosphate (source: ndc)
Application Number ANDA211610 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
  • 30 mg/1
source: ndc
Packaging
  • 20 TABLET in 1 BOTTLE (68071-3658-2)
  • 30 TABLET in 1 BOTTLE (68071-3658-3)
  • 15 TABLET in 1 BOTTLE (68071-3658-5)
source: ndc

Packages (3)

68071-3658-2 20 TABLET in 1 BOTTLE (68071-3658-2) 68071-3658-3 30 TABLET in 1 BOTTLE (68071-3658-3) 68071-3658-5 15 TABLET in 1 BOTTLE (68071-3658-5)

Ingredients (2)

acetaminophen (300 mg/1) codeine phosphate (30 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": "2baebda6-c349-721c-e063-6394a90a3552", "openfda": {"upc": ["0368071365856"], "unii": ["362O9ITL9D", "GSL05Y1MN6"], "rxcui": ["993781"], "spl_set_id": ["1e932a34-a7d3-e4ec-e063-6294a90a25b1"], "manufacturer_name": ["NuCare Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET in 1 BOTTLE (68071-3658-2)", "package_ndc": "68071-3658-2", "marketing_start_date": "20250114"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68071-3658-3)", "package_ndc": "68071-3658-3", "marketing_start_date": "20240731"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE (68071-3658-5)", "package_ndc": "68071-3658-5", "marketing_start_date": "20240731"}], "brand_name": "ACETAMINOPHEN AND CODEINE PHOSPHATE", "product_id": "68071-3658_2baebda6-c349-721c-e063-6394a90a3552", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "68071-3658", "dea_schedule": "CIII", "generic_name": "acetaminophen and codeine phosphate", "labeler_name": "NuCare Pharmaceuticals, 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": "30 mg/1"}], "application_number": "ANDA211610", "marketing_category": "ANDA", "marketing_start_date": "20190802", "listing_expiration_date": "20261231"}