acetaminophen and codeine phosphate

Generic: acetaminophen and codeine phosphate

Labeler: specgx llc
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 specgx llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 300 mg/1, codeine phosphate 15 mg/1

Manufacturer
SpecGx LLC

Identifiers & Regulatory

Product NDC 0406-0483
Product ID 0406-0483_d718c5ef-69f7-4342-8ac6-772b45f6a726
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040419
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2001-05-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04060483
Hyphenated Format 0406-0483

Supplemental Identifiers

RxCUI
993770 993781 993890
UPC
0304060485051 0304060484108 0304060483019
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 ANDA040419 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
  • 15 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0406-0483-01)
source: ndc

Packages (1)

0406-0483-01 100 TABLET in 1 BOTTLE (0406-0483-01)

Ingredients (2)

acetaminophen (300 mg/1) codeine phosphate (15 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": "d718c5ef-69f7-4342-8ac6-772b45f6a726", "openfda": {"upc": ["0304060485051", "0304060484108", "0304060483019"], "unii": ["362O9ITL9D", "GSL05Y1MN6"], "rxcui": ["993770", "993781", "993890"], "spl_set_id": ["eadc80fa-13c3-471a-a22f-6fe7e1ab290f"], "manufacturer_name": ["SpecGx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0406-0483-01)", "package_ndc": "0406-0483-01", "marketing_start_date": "20010531"}], "brand_name": "ACETAMINOPHEN AND CODEINE PHOSPHATE", "product_id": "0406-0483_d718c5ef-69f7-4342-8ac6-772b45f6a726", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0406-0483", "dea_schedule": "CIII", "generic_name": "acetaminophen and codeine phosphate", "labeler_name": "SpecGx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ACETAMINOPHEN AND CODEINE PHOSPHATE", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "300 mg/1"}, {"name": "CODEINE PHOSPHATE", "strength": "15 mg/1"}], "application_number": "ANDA040419", "marketing_category": "ANDA", "marketing_start_date": "20010531", "listing_expiration_date": "20261231"}