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 325 mg/1

Manufacturer
AARNA USA INC.

Identifiers & Regulatory

Product NDC 82568-0001
Product ID 82568-0001_33f0e822-28b0-9bb2-e063-6294a90a5175
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 825680001
Hyphenated Format 82568-0001

Supplemental Identifiers

RxCUI
313782
UPC
0382568000112
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
  • 325 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (82568-0001-1)
  • 1000 TABLET in 1 BOTTLE (82568-0001-2)
  • 100 TABLET in 1 PACKAGE (82568-0001-3)
source: ndc

Packages (3)

Ingredients (1)

acetaminophen (325 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "33f0e822-28b0-9bb2-e063-6294a90a5175", "openfda": {"upc": ["0382568000112"], "unii": ["362O9ITL9D"], "rxcui": ["313782"], "spl_set_id": ["33f0e822-28af-9bb2-e063-6294a90a5175"], "manufacturer_name": ["AARNA USA INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (82568-0001-1)", "package_ndc": "82568-0001-1", "marketing_start_date": "20250515"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (82568-0001-2)", "package_ndc": "82568-0001-2", "marketing_start_date": "20250515"}, {"sample": false, "description": "100 TABLET in 1 PACKAGE (82568-0001-3)", "package_ndc": "82568-0001-3", "marketing_start_date": "20250515"}], "brand_name": "ACETAMINOPHEN", "product_id": "82568-0001_33f0e822-28b0-9bb2-e063-6294a90a5175", "dosage_form": "TABLET", "product_ndc": "82568-0001", "generic_name": "ACETAMINOPHEN", "labeler_name": "AARNA USA INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ACETAMINOPHEN", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250515", "listing_expiration_date": "20261231"}