acetaminophen and ibuprofen (69452-469)

Drug Facts

Product Profile

Brand Name acetaminophen and ibuprofen

Generic Name acetaminophen and ibuprofen

Labeler bionpharma inc.

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

acetaminophen 250 mg/1, ibuprofen 125 mg/1

Manufacturer

BIONPHARMA INC.

Identifiers & Regulatory

Product NDC 69452-469

Product ID 69452-469_4834b0ac-3df4-e9af-e063-6394a90a3ab2

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA216999

Listing Expiration 2027-12-31

Marketing Start 2026-01-13

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 69452469

Hyphenated Format 69452-469

Supplemental Identifiers

RxCUI

2387532

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 and ibuprofen (source: ndc)

Generic Name acetaminophen and ibuprofen (source: ndc)

Application Number ANDA216999 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

250 mg/1
125 mg/1

source: ndc

Packaging

1 BOTTLE in 1 CARTON (69452-469-22) / 120 TABLET, FILM COATED in 1 BOTTLE

source: ndc

Packages (1)

69452-469-22 1 BOTTLE in 1 CARTON (69452-469-22) / 120 TABLET, FILM COATED in 1 BOTTLE

Ingredients (2)

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

Linked Drug Pages (1)

Acetaminophen and Ibuprofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "4834b0ac-3df4-e9af-e063-6394a90a3ab2", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["362O9ITL9D", "WK2XYI10QM"], "rxcui": ["2387532"], "spl_set_id": ["4834aa7f-cb0c-ec58-e063-6394a90ae2fc"], "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": ["BIONPHARMA INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (69452-469-22)  / 120 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "69452-469-22", "marketing_start_date": "20260113"}], "brand_name": "Acetaminophen and Ibuprofen", "product_id": "69452-469_4834b0ac-3df4-e9af-e063-6394a90a3ab2", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "69452-469", "generic_name": "Acetaminophen and Ibuprofen", "labeler_name": "BIONPHARMA INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acetaminophen and Ibuprofen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "250 mg/1"}, {"name": "IBUPROFEN", "strength": "125 mg/1"}], "application_number": "ANDA216999", "marketing_category": "ANDA", "marketing_start_date": "20260113", "listing_expiration_date": "20271231"}