ibuprofen and famotidine (80425-0422)

Drug Facts

Product Profile

Brand Name ibuprofen and famotidine

Generic Name ibuprofen and famotidine

Labeler advanced rx of tennessee, llc

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

famotidine 26.6 mg/1, ibuprofen 800 mg/1

Manufacturer

Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0422

Product ID 80425-0422_1d625438-34dd-fbba-e063-6294a90afd2f

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA211890

Listing Expiration 2026-12-31

Marketing Start 2024-07-16

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 804250422

Hyphenated Format 80425-0422

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 ANDA211890 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

26.6 mg/1
800 mg/1

source: ndc

Packaging

30 TABLET, FILM COATED in 1 BOTTLE (80425-0422-1)
60 TABLET, FILM COATED in 1 BOTTLE (80425-0422-2)
90 TABLET, FILM COATED in 1 BOTTLE (80425-0422-3)

source: ndc

Packages (3)

80425-0422-1 30 TABLET, FILM COATED in 1 BOTTLE (80425-0422-1) 80425-0422-2 60 TABLET, FILM COATED in 1 BOTTLE (80425-0422-2) 80425-0422-3 90 TABLET, FILM COATED in 1 BOTTLE (80425-0422-3)

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": "1d625438-34dd-fbba-e063-6294a90afd2f", "openfda": {"nui": ["N0000000151", "N0000175784", "N0000000160", "M0001335", "N0000175722"], "unii": ["5QZO15J2Z8", "WK2XYI10QM"], "rxcui": ["1100066"], "spl_set_id": ["1d625438-34dc-fbba-e063-6294a90afd2f"], "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, FILM COATED in 1 BOTTLE (80425-0422-1)", "package_ndc": "80425-0422-1", "marketing_start_date": "20240716"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (80425-0422-2)", "package_ndc": "80425-0422-2", "marketing_start_date": "20240716"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (80425-0422-3)", "package_ndc": "80425-0422-3", "marketing_start_date": "20240716"}], "brand_name": "Ibuprofen and famotidine", "product_id": "80425-0422_1d625438-34dd-fbba-e063-6294a90afd2f", "dosage_form": "TABLET, FILM COATED", "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": "80425-0422", "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": "ANDA211890", "marketing_category": "ANDA", "marketing_start_date": "20240716", "listing_expiration_date": "20261231"}