acetaminophen extended-release

Generic: acetaminophen

Labeler: magno-humphries, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen extended-release
Generic Name acetaminophen
Labeler magno-humphries, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/1

Manufacturer
Magno-Humphries, Inc.

Identifiers & Regulatory

Product NDC 54257-573
Product ID 54257-573_cf6e6c2c-3775-f475-e053-2995a90a2754
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA211544
Listing Expiration 2026-12-31
Marketing Start 2020-01-24

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54257573
Hyphenated Format 54257-573

Supplemental Identifiers

RxCUI
1148399
UPC
0043292565239
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 extended-release (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
  • 200 TABLET in 1 BOTTLE (54257-573-03)
source: ndc

Packages (1)

54257-573-03 200 TABLET in 1 BOTTLE (54257-573-03)

Ingredients (1)

acetaminophen (650 mg/1)

Linked Drug Pages (1)

Acetaminophen Extended-Release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "cf6e6c2c-3775-f475-e053-2995a90a2754", "openfda": {"upc": ["0043292565239"], "unii": ["362O9ITL9D"], "rxcui": ["1148399"], "spl_set_id": ["9d22bedb-9fc9-8421-e053-2a95a90acf4a"], "manufacturer_name": ["Magno-Humphries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "200 TABLET in 1 BOTTLE (54257-573-03)", "package_ndc": "54257-573-03", "marketing_start_date": "20200124"}], "brand_name": "Acetaminophen Extended-Release", "product_id": "54257-573_cf6e6c2c-3775-f475-e053-2995a90a2754", "dosage_form": "TABLET", "product_ndc": "54257-573", "generic_name": "ACETAMINOPHEN", "labeler_name": "Magno-Humphries, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acetaminophen Extended-Release", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/1"}], "application_number": "ANDA211544", "marketing_category": "ANDA", "marketing_start_date": "20200124", "listing_expiration_date": "20261231"}