ibuprofen and famotidine (72578-214)

Drug Facts

Product Profile

Brand Name ibuprofen and famotidine

Generic Name ibuprofen and famotidine

Labeler viona pharmaceuticals inc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

famotidine 26.6 mg/1, ibuprofen 800 mg/1

Manufacturer

Viona Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 72578-214

Product ID 72578-214_d0498b4c-d60a-4a93-b151-d3bc4658787a

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA218684

Listing Expiration 2026-12-31

Marketing Start 2025-06-01

Pharmacologic Class

Established (EPC)

histamine-2 receptor antagonist [epc] nonsteroidal anti-inflammatory drug [epc]

Mechanism of Action

histamine h2 receptor antagonists [moa] cyclooxygenase inhibitors [moa]

Chemical Structure

anti-inflammatory agents, non-steroidal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72578214

Hyphenated Format 72578-214

Supplemental Identifiers

RxCUI

1100066

UNII

5QZO15J2Z8 WK2XYI10QM

NUI

N0000000151 N0000175784 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 ibuprofen and famotidine (source: ndc)

Generic Name ibuprofen and famotidine (source: ndc)

Application Number ANDA218684 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

26.6 mg/1
800 mg/1

source: ndc

Packaging

90 TABLET in 1 BOTTLE (72578-214-16)

source: ndc

Packages (1)

72578-214-16 90 TABLET in 1 BOTTLE (72578-214-16)

Ingredients (2)

famotidine (26.6 mg/1) ibuprofen (800 mg/1)

Linked Drug Pages (1)

Ibuprofen and Famotidine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "d0498b4c-d60a-4a93-b151-d3bc4658787a", "openfda": {"nui": ["N0000000151", "N0000175784", "N0000000160", "M0001335", "N0000175722"], "unii": ["5QZO15J2Z8", "WK2XYI10QM"], "rxcui": ["1100066"], "spl_set_id": ["66524c84-35bc-4e7f-897a-f63fa4bca432"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]", "Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Viona Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (72578-214-16)", "package_ndc": "72578-214-16", "marketing_start_date": "20250601"}], "brand_name": "Ibuprofen and Famotidine", "product_id": "72578-214_d0498b4c-d60a-4a93-b151-d3bc4658787a", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "72578-214", "generic_name": "Ibuprofen and Famotidine", "labeler_name": "Viona Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ibuprofen and Famotidine", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "26.6 mg/1"}, {"name": "IBUPROFEN", "strength": "800 mg/1"}], "application_number": "ANDA218684", "marketing_category": "ANDA", "marketing_start_date": "20250601", "listing_expiration_date": "20261231"}