acetaminophen extended-release tablets, 650 mg

Generic: acetaminophen

Labeler: marksans pharma limited
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen extended-release tablets, 650 mg
Generic Name acetaminophen
Labeler marksans pharma limited
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/1

Manufacturer
MARKSANS PHARMA LIMITED

Identifiers & Regulatory

Product NDC 25000-108
Product ID 25000-108_9e2c09cd-1bd4-4a86-8911-ba904d8a76cb
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA215486
Listing Expiration 2026-12-31
Marketing Start 2022-10-14

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25000108
Hyphenated Format 25000-108

Supplemental Identifiers

RxCUI
1148399
UPC
0325000071110 0325000108021 0325000071028 0325000071103 0325000108083 0325000071080 0325000071455
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 tablets, 650 mg (source: ndc)
Generic Name acetaminophen (source: ndc)
Application Number ANDA215486 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (25000-108-02) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (25000-108-08) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE
source: ndc

Packages (2)

25000-108-02 1 BOTTLE in 1 CARTON (25000-108-02) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE 25000-108-08 1 BOTTLE in 1 CARTON (25000-108-08) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE

Ingredients (1)

acetaminophen (650 mg/1)

Linked Drug Pages (1)

Acetaminophen Extended-Release Tablets, 650 mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9e2c09cd-1bd4-4a86-8911-ba904d8a76cb", "openfda": {"upc": ["0325000071110", "0325000108021", "0325000071028", "0325000071103", "0325000108083", "0325000071080", "0325000071455"], "unii": ["362O9ITL9D"], "rxcui": ["1148399"], "spl_set_id": ["d973a910-5fe0-4a85-884d-2c3987836691"], "manufacturer_name": ["MARKSANS PHARMA LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (25000-108-02)  / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "25000-108-02", "marketing_start_date": "20221014"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (25000-108-08)  / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "25000-108-08", "marketing_start_date": "20221014"}], "brand_name": "Acetaminophen Extended-Release Tablets, 650 mg", "product_id": "25000-108_9e2c09cd-1bd4-4a86-8911-ba904d8a76cb", "dosage_form": "TABLET, EXTENDED RELEASE", "product_ndc": "25000-108", "generic_name": "Acetaminophen", "labeler_name": "MARKSANS PHARMA LIMITED", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acetaminophen Extended-Release Tablets, 650 mg", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/1"}], "application_number": "ANDA215486", "marketing_category": "ANDA", "marketing_start_date": "20221014", "listing_expiration_date": "20261231"}