ed apap

Generic: acetaminophen

Labeler: edwards pharmaceuticals, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name ed apap
Generic Name acetaminophen
Labeler edwards pharmaceuticals, inc.
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

acetaminophen 160 mg/5mL

Manufacturer
EDWARDS PHARMACEUTICALS, INC.

Identifiers & Regulatory

Product NDC 0485-0057
Product ID 0485-0057_4742634e-a794-9047-e063-6394a90a2cd3
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2012-03-07

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04850057
Hyphenated Format 0485-0057

Supplemental Identifiers

RxCUI
307675
UNII
362O9ITL9D

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 ed apap (source: ndc)
Generic Name acetaminophen (source: ndc)
Application Number M013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 160 mg/5mL
source: ndc
Packaging
  • 236 mL in 1 BOTTLE, PLASTIC (0485-0057-08)
source: ndc

Packages (1)

0485-0057-08 236 mL in 1 BOTTLE, PLASTIC (0485-0057-08)

Ingredients (1)

acetaminophen (160 mg/5mL)

Linked Drug Pages (1)

ED APAP ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4742634e-a794-9047-e063-6394a90a2cd3", "openfda": {"unii": ["362O9ITL9D"], "rxcui": ["307675"], "spl_set_id": ["f76d5fff-ebea-40f9-aad3-4064a0c863f0"], "manufacturer_name": ["EDWARDS PHARMACEUTICALS, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "236 mL in 1 BOTTLE, PLASTIC (0485-0057-08)", "package_ndc": "0485-0057-08", "marketing_start_date": "20120307"}], "brand_name": "ED APAP", "product_id": "0485-0057_4742634e-a794-9047-e063-6394a90a2cd3", "dosage_form": "LIQUID", "product_ndc": "0485-0057", "generic_name": "ACETAMINOPHEN", "labeler_name": "EDWARDS PHARMACEUTICALS, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ED APAP", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "160 mg/5mL"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20120307", "listing_expiration_date": "20261231"}