acetaminophen and ibuprofen (69452-394)

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 69452-394

Product ID 69452-394_45c4da17-7d0d-421b-e063-6294a90a6a2e

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA216999

Listing Expiration 2026-12-31

Marketing Start 2023-09-08

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 69452394

Hyphenated Format 69452-394

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

216 TABLET, FILM COATED in 1 BOTTLE (69452-394-64)
400 TABLET, FILM COATED in 1 BOTTLE (69452-394-81)

source: ndc

Packages (2)

69452-394-64 216 TABLET, FILM COATED in 1 BOTTLE (69452-394-64) 69452-394-81 400 TABLET, FILM COATED in 1 BOTTLE (69452-394-81)

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": "45c4da17-7d0d-421b-e063-6294a90a6a2e", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["362O9ITL9D", "WK2XYI10QM"], "rxcui": ["2387532"], "spl_set_id": ["04ccc4b2-0cfd-3012-e063-6394a90afa79"], "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": "216 TABLET, FILM COATED in 1 BOTTLE (69452-394-64)", "package_ndc": "69452-394-64", "marketing_start_date": "20230908"}, {"sample": false, "description": "400 TABLET, FILM COATED in 1 BOTTLE (69452-394-81)", "package_ndc": "69452-394-81", "marketing_start_date": "20251205"}], "brand_name": "Acetaminophen and Ibuprofen", "product_id": "69452-394_45c4da17-7d0d-421b-e063-6294a90a6a2e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "69452-394", "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": "20230908", "listing_expiration_date": "20261231"}