acetaminophen

Generic: acetaminophen

Labeler: granules usa, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen
Generic Name acetaminophen
Labeler granules usa, inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/1

Manufacturer
Granules USA, Inc.

Identifiers & Regulatory

Product NDC 69848-015
Product ID 69848-015_4690a42a-ee23-e19b-e063-6294a90a2d9f
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA211544
Listing Expiration 2026-12-31
Marketing Start 2019-12-31

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69848015
Hyphenated Format 69848-015

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
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69848-015-10)
  • 24 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69848-015-24)
source: ndc

Packages (2)

69848-015-10 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69848-015-10) 69848-015-24 24 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69848-015-24)

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": "4690a42a-ee23-e19b-e063-6294a90a2d9f", "openfda": {"unii": ["362O9ITL9D"], "rxcui": ["1148399"], "spl_set_id": ["96131c7b-bdff-0642-e053-2a95a90a4f32"], "manufacturer_name": ["Granules USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69848-015-10)", "package_ndc": "69848-015-10", "marketing_start_date": "20191231"}, {"sample": false, "description": "24 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69848-015-24)", "package_ndc": "69848-015-24", "marketing_start_date": "20221130"}], "brand_name": "Acetaminophen", "product_id": "69848-015_4690a42a-ee23-e19b-e063-6294a90a2d9f", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "product_ndc": "69848-015", "generic_name": "Acetaminophen", "labeler_name": "Granules USA, Inc.", "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": "20191231", "listing_expiration_date": "20261231"}