ibuprofen and famotidine (80425-0483)

Drug Facts

Product Profile

Brand Name ibuprofen and famotidine

Generic Name ibuprofen and famotidine

Labeler advanced rx of tennessee, llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

famotidine 26.6 mg/1, ibuprofen 800 mg/1

Manufacturer

Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0483

Product ID 80425-0483_2cf74136-002a-d2a4-e063-6294a90ae545

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA203658

Listing Expiration 2026-12-31

Marketing Start 2024-03-22

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 804250483

Hyphenated Format 80425-0483

Supplemental Identifiers

RxCUI

1100066

UNII

5QZO15J2Z8 WK2XYI10QM

NUI

N0000000151 N0000175784 N0000000160 M0001335 N0000175722

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 ANDA203658 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

26.6 mg/1
800 mg/1

source: ndc

Packaging

30 TABLET in 1 BOTTLE (80425-0483-1)
60 TABLET in 1 BOTTLE (80425-0483-2)
90 TABLET in 1 BOTTLE (80425-0483-3)

source: ndc

Packages (3)

80425-0483-1 30 TABLET in 1 BOTTLE (80425-0483-1) 80425-0483-2 60 TABLET in 1 BOTTLE (80425-0483-2) 80425-0483-3 90 TABLET in 1 BOTTLE (80425-0483-3)

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": "2cf74136-002a-d2a4-e063-6294a90ae545", "openfda": {"nui": ["N0000000151", "N0000175784", "N0000000160", "M0001335", "N0000175722"], "unii": ["5QZO15J2Z8", "WK2XYI10QM"], "rxcui": ["1100066"], "spl_set_id": ["2cf7412a-7f94-e39f-e063-6294a90a5bc2"], "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": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (80425-0483-1)", "package_ndc": "80425-0483-1", "marketing_start_date": "20240322"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (80425-0483-2)", "package_ndc": "80425-0483-2", "marketing_start_date": "20240322"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (80425-0483-3)", "package_ndc": "80425-0483-3", "marketing_start_date": "20240322"}], "brand_name": "Ibuprofen and famotidine", "product_id": "80425-0483_2cf74136-002a-d2a4-e063-6294a90ae545", "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": "80425-0483", "generic_name": "Ibuprofen and famotidine", "labeler_name": "Advanced Rx of Tennessee, LLC", "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": "ANDA203658", "marketing_category": "ANDA", "marketing_start_date": "20240322", "listing_expiration_date": "20261231"}