acetaminophen 250 mg and ibuprofen 125 mg

Generic: acetaminophen 250 mg and ibuprofen 125 mg tablets

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

Drug Facts

Product Profile

Brand Name acetaminophen 250 mg and ibuprofen 125 mg
Generic Name acetaminophen 250 mg and ibuprofen 125 mg tablets
Labeler marksans pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

acetaminophen 250 mg/1, ibuprofen 125 mg/1

Manufacturer
MARKSANS PHARMA LIMITED

Identifiers & Regulatory

Product NDC 25000-080
Product ID 25000-080_38a01bed-7a8b-4aed-97c1-cc1545f76f79
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA216994
Listing Expiration 2026-12-31
Marketing Start 2023-07-11

Pharmacologic Class

Established (EPC)
nonsteroidal anti-inflammatory drug [epc]
Mechanism of Action
cyclooxygenase inhibitors [moa]
Chemical Structure
anti-inflammatory agents, non-steroidal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25000080
Hyphenated Format 25000-080

Supplemental Identifiers

RxCUI
2387532
UPC
0325000080723 0325000080075 0325000080747
UNII
362O9ITL9D WK2XYI10QM
NUI
N0000000160 M0001335 N0000175722

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 250 mg and ibuprofen 125 mg (source: ndc)
Generic Name acetaminophen 250 mg and ibuprofen 125 mg tablets (source: ndc)
Application Number ANDA216994 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
  • 125 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (25000-080-07) / 90 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (25000-080-72) / 18 TABLET, FILM COATED in 1 BOTTLE
  • 288 TABLET, FILM COATED in 1 BOTTLE (25000-080-74)
source: ndc

Packages (3)

25000-080-07 1 BOTTLE in 1 CARTON (25000-080-07) / 90 TABLET, FILM COATED in 1 BOTTLE 25000-080-72 1 BOTTLE in 1 CARTON (25000-080-72) / 18 TABLET, FILM COATED in 1 BOTTLE 25000-080-74 288 TABLET, FILM COATED in 1 BOTTLE (25000-080-74)

Ingredients (2)

acetaminophen (250 mg/1) ibuprofen (125 mg/1)

Linked Drug Pages (1)

Acetaminophen 250 mg and Ibuprofen 125 mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "38a01bed-7a8b-4aed-97c1-cc1545f76f79", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0325000080723", "0325000080075", "0325000080747"], "unii": ["362O9ITL9D", "WK2XYI10QM"], "rxcui": ["2387532"], "spl_set_id": ["46121a30-1361-4f2b-9f3f-3cedabd66c33"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["MARKSANS PHARMA LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (25000-080-07)  / 90 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "25000-080-07", "marketing_start_date": "20230711"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (25000-080-72)  / 18 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "25000-080-72", "marketing_start_date": "20230711"}, {"sample": false, "description": "288 TABLET, FILM COATED in 1 BOTTLE (25000-080-74)", "package_ndc": "25000-080-74", "marketing_start_date": "20230711"}], "brand_name": "Acetaminophen 250 mg and Ibuprofen 125 mg", "product_id": "25000-080_38a01bed-7a8b-4aed-97c1-cc1545f76f79", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "25000-080", "generic_name": "Acetaminophen 250 mg and Ibuprofen 125 mg Tablets", "labeler_name": "MARKSANS PHARMA LIMITED", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acetaminophen 250 mg and Ibuprofen 125 mg", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "250 mg/1"}, {"name": "IBUPROFEN", "strength": "125 mg/1"}], "application_number": "ANDA216994", "marketing_category": "ANDA", "marketing_start_date": "20230711", "listing_expiration_date": "20261231"}