acetaminophen

Generic: acetaminophen

Labeler: fred's inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen
Generic Name acetaminophen
Labeler fred's inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/1

Manufacturer
Fred's Inc.

Identifiers & Regulatory

Product NDC 55315-333
Product ID 55315-333_bb89acc6-20df-465f-aca0-424c0d4dc32f
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076200
Listing Expiration 2026-12-31
Marketing Start 2004-04-30

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55315333
Hyphenated Format 55315-333

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 ANDA076200 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/1
source: ndc
Packaging
  • 50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55315-333-50)
source: ndc

Packages (1)

55315-333-50 50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55315-333-50)

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": "bb89acc6-20df-465f-aca0-424c0d4dc32f", "openfda": {"unii": ["362O9ITL9D"], "rxcui": ["1148399"], "spl_set_id": ["070569ec-82b1-4b26-b38b-3fb3caf71f19"], "manufacturer_name": ["Fred's Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55315-333-50)", "package_ndc": "55315-333-50", "marketing_start_date": "20191224"}], "brand_name": "Acetaminophen", "product_id": "55315-333_bb89acc6-20df-465f-aca0-424c0d4dc32f", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "product_ndc": "55315-333", "generic_name": "Acetaminophen", "labeler_name": "Fred's Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acetaminophen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/1"}], "application_number": "ANDA076200", "marketing_category": "ANDA", "marketing_start_date": "20040430", "listing_expiration_date": "20261231"}