acetaminophen

Generic: acetaminophen

Labeler: major pharmaceuticals
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen
Generic Name acetaminophen
Labeler major pharmaceuticals
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/1

Manufacturer
MAJOR PHARMACEUTICALS

Identifiers & Regulatory

Product NDC 0904-7314
Product ID 0904-7314_465309f8-55b3-9cbf-e063-6294a90a8ca8
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA211544
Listing Expiration 2026-12-31
Marketing Start 2023-03-03

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047314
Hyphenated Format 0904-7314

Supplemental Identifiers

RxCUI
1148399
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 ANDA211544 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/1
source: ndc
Packaging
  • 400 TABLET in 1 BOTTLE (0904-7314-27)
  • 100 TABLET in 1 BOTTLE (0904-7314-60)
source: ndc

Packages (2)

0904-7314-27 400 TABLET in 1 BOTTLE (0904-7314-27) 0904-7314-60 100 TABLET in 1 BOTTLE (0904-7314-60)

Ingredients (1)

acetaminophen (650 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": "465309f8-55b3-9cbf-e063-6294a90a8ca8", "openfda": {"unii": ["362O9ITL9D"], "rxcui": ["1148399"], "spl_set_id": ["efd0a432-abbb-1f88-e053-2995a90a8ce5"], "manufacturer_name": ["MAJOR PHARMACEUTICALS"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "400 TABLET in 1 BOTTLE (0904-7314-27)", "package_ndc": "0904-7314-27", "marketing_start_date": "20230303"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (0904-7314-60)", "package_ndc": "0904-7314-60", "marketing_start_date": "20230303"}], "brand_name": "Acetaminophen", "product_id": "0904-7314_465309f8-55b3-9cbf-e063-6294a90a8ca8", "dosage_form": "TABLET", "product_ndc": "0904-7314", "generic_name": "Acetaminophen", "labeler_name": "MAJOR PHARMACEUTICALS", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acetaminophen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/1"}], "application_number": "ANDA211544", "marketing_category": "ANDA", "marketing_start_date": "20230303", "listing_expiration_date": "20261231"}