acetaminophen

Generic: acetaminophen

Labeler: aaa pharmaceutical, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen
Generic Name acetaminophen
Labeler aaa pharmaceutical, inc.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

acetaminophen 500 mg/1

Manufacturer
AAA Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 57344-004
Product ID 57344-004_284cd503-79e7-85a0-e063-6394a90a4783
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2012-04-13

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57344004
Hyphenated Format 57344-004

Supplemental Identifiers

RxCUI
198440
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
  • 1 BOTTLE, PLASTIC in 1 CARTON (57344-004-04) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC
  • 500 TABLET, COATED in 1 BOTTLE (57344-004-06)
source: ndc

Packages (2)

57344-004-04 1 BOTTLE, PLASTIC in 1 CARTON (57344-004-04) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC 57344-004-06 500 TABLET, COATED in 1 BOTTLE (57344-004-06)

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": "284cd503-79e7-85a0-e063-6394a90a4783", "openfda": {"unii": ["362O9ITL9D"], "rxcui": ["198440"], "spl_set_id": ["2d98e390-4f2a-41cc-b307-3d2f6a3700dd"], "manufacturer_name": ["AAA Pharmaceutical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (57344-004-04)  / 100 TABLET, COATED in 1 BOTTLE, PLASTIC", "package_ndc": "57344-004-04", "marketing_start_date": "20120413"}, {"sample": false, "description": "500 TABLET, COATED in 1 BOTTLE (57344-004-06)", "package_ndc": "57344-004-06", "marketing_start_date": "20240315"}], "brand_name": "Acetaminophen", "product_id": "57344-004_284cd503-79e7-85a0-e063-6394a90a4783", "dosage_form": "TABLET, COATED", "product_ndc": "57344-004", "generic_name": "Acetaminophen", "labeler_name": "AAA Pharmaceutical, 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": "20120413", "listing_expiration_date": "20261231"}