major acetaminophen

Generic: acetaminophen

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

Drug Facts

Product Profile

Brand Name major acetaminophen
Generic Name acetaminophen
Labeler major pharmaceuticals
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6883
Product ID 0904-6883_69ef9f35-add0-44cf-944d-fc69d1a7dd02
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA075077
Listing Expiration 2026-12-31
Marketing Start 2019-03-04

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09046883
Hyphenated Format 0904-6883

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 major acetaminophen (source: ndc)
Generic Name acetaminophen (source: ndc)
Application Number ANDA075077 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/1
source: ndc
Packaging
  • 400 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0904-6883-65)
source: ndc

Packages (1)

0904-6883-65 400 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0904-6883-65)

Ingredients (1)

acetaminophen (650 mg/1)

Linked Drug Pages (1)

major acetaminophen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "69ef9f35-add0-44cf-944d-fc69d1a7dd02", "openfda": {"unii": ["362O9ITL9D"], "rxcui": ["1148399"], "spl_set_id": ["ca9e1dae-eefb-4653-952f-2fde09059693"], "manufacturer_name": ["Major Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "400 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0904-6883-65)", "package_ndc": "0904-6883-65", "marketing_start_date": "20190304"}], "brand_name": "major acetaminophen", "product_id": "0904-6883_69ef9f35-add0-44cf-944d-fc69d1a7dd02", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "product_ndc": "0904-6883", "generic_name": "Acetaminophen", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN OTC DRUG", "brand_name_base": "major acetaminophen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/1"}], "application_number": "ANDA075077", "marketing_category": "ANDA", "marketing_start_date": "20190304", "listing_expiration_date": "20261231"}