acetaminophen

Generic: acetaminophen

Labeler: aarna usa inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen
Generic Name acetaminophen
Labeler aarna usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 500 mg/1

Manufacturer
AARNA USA INC.

Identifiers & Regulatory

Product NDC 82568-0002
Product ID 82568-0002_34157f6a-3032-4388-e063-6394a90a670f
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2025-05-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 825680002
Hyphenated Format 82568-0002

Supplemental Identifiers

RxCUI
198440
UPC
0382568000228 0382568000211
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 acetaminophen (source: ndc)
Generic Name acetaminophen (source: ndc)
Application Number M013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (82568-0002-1)
  • 1000 TABLET in 1 BOTTLE (82568-0002-2)
source: ndc

Packages (2)

82568-0002-1 100 TABLET in 1 BOTTLE (82568-0002-1) 82568-0002-2 1000 TABLET in 1 BOTTLE (82568-0002-2)

Ingredients (1)

acetaminophen (500 mg/1)

Linked Drug Pages (1)

ACETAMINOPHEN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "34157f6a-3032-4388-e063-6394a90a670f", "openfda": {"upc": ["0382568000228", "0382568000211"], "unii": ["362O9ITL9D"], "rxcui": ["198440"], "spl_set_id": ["34157f6a-3031-4388-e063-6394a90a670f"], "manufacturer_name": ["AARNA USA INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (82568-0002-1)", "package_ndc": "82568-0002-1", "marketing_start_date": "20250515"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (82568-0002-2)", "package_ndc": "82568-0002-2", "marketing_start_date": "20250515"}], "brand_name": "ACETAMINOPHEN", "product_id": "82568-0002_34157f6a-3032-4388-e063-6394a90a670f", "dosage_form": "TABLET", "product_ndc": "82568-0002", "generic_name": "ACETAMINOPHEN", "labeler_name": "AARNA USA INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ACETAMINOPHEN", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "500 mg/1"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250515", "listing_expiration_date": "20261231"}