acetaminophen and ibuprofen (70000-0622)

Drug Facts

Product Profile

Brand Name acetaminophen and ibuprofen

Generic Name acetaminophen and ibuprofen

Labeler leader/ cardinal health 110, inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

acetaminophen 250 mg/1, ibuprofen 125 mg/1

Manufacturer

LEADER/ Cardinal Health 110, Inc.

Identifiers & Regulatory

Product NDC 70000-0622

Product ID 70000-0622_4652fd1e-ed26-2a97-e063-6394a90a7e1a

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA216592

Listing Expiration 2026-12-31

Marketing Start 2023-07-15

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 700000622

Hyphenated Format 70000-0622

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 ANDA216592 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

250 mg/1
125 mg/1

source: ndc

Packaging

18 TABLET in 1 BOTTLE (70000-0622-1)
36 TABLET in 1 BOTTLE (70000-0622-2)

source: ndc

Packages (2)

70000-0622-1 18 TABLET in 1 BOTTLE (70000-0622-1) 70000-0622-2 36 TABLET in 1 BOTTLE (70000-0622-2)

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": "4652fd1e-ed26-2a97-e063-6394a90a7e1a", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["362O9ITL9D", "WK2XYI10QM"], "rxcui": ["2387532"], "spl_set_id": ["f1d69088-4d52-cbb5-e053-2995a90a3ec8"], "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": ["LEADER/ Cardinal Health 110, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "18 TABLET in 1 BOTTLE (70000-0622-1)", "package_ndc": "70000-0622-1", "marketing_start_date": "20230715"}, {"sample": false, "description": "36 TABLET in 1 BOTTLE (70000-0622-2)", "package_ndc": "70000-0622-2", "marketing_start_date": "20230715"}], "brand_name": "Acetaminophen and Ibuprofen", "product_id": "70000-0622_4652fd1e-ed26-2a97-e063-6394a90a7e1a", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "70000-0622", "generic_name": "Acetaminophen and Ibuprofen", "labeler_name": "LEADER/ Cardinal Health 110, 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": "ANDA216592", "marketing_category": "ANDA", "marketing_start_date": "20230715", "listing_expiration_date": "20261231"}