acetaminophen and codeine phosphate

Generic: acetaminophen and codeine phosphate

Labeler: eywa pharma 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 eywa pharma inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Eywa Pharma Inc

Identifiers & Regulatory

Product NDC 71930-054
Product ID 71930-054_5818712b-07d5-490a-9e8d-e895077a807d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211610
DEA Schedule cii
Listing Expiration 2027-12-31
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 71930054
Hyphenated Format 71930-054

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 ANDA211610 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
  • 15 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (71930-054-12)
source: ndc

Packages (1)

71930-054-12 100 TABLET in 1 BOTTLE (71930-054-12)

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": "5818712b-07d5-490a-9e8d-e895077a807d", "openfda": {"unii": ["362O9ITL9D", "GSL05Y1MN6"], "rxcui": ["993770", "993781", "993890"], "spl_set_id": ["79377617-686b-4640-b2b8-e1358cf82358"], "manufacturer_name": ["Eywa Pharma Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (71930-054-12)", "package_ndc": "71930-054-12", "marketing_start_date": "20190802"}], "brand_name": "ACETAMINOPHEN AND CODEINE PHOSPHATE", "product_id": "71930-054_5818712b-07d5-490a-9e8d-e895077a807d", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "71930-054", "dea_schedule": "CII", "generic_name": "acetaminophen and codeine phosphate", "labeler_name": "Eywa Pharma 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": "15 mg/1"}], "application_number": "ANDA211610", "marketing_category": "ANDA", "marketing_start_date": "20190802", "listing_expiration_date": "20271231"}