ibuprofen and famotidine (85509-1315)

Drug Facts

Product Profile

Brand Name ibuprofen and famotidine

Generic Name ibuprofen and famotidine

Labeler phoenix rx llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

famotidine 26.6 mg/1, ibuprofen 800 mg/1

Manufacturer

PHOENIX RX LLC

Identifiers & Regulatory

Product NDC 85509-1315

Product ID 85509-1315_3ff33409-9785-67bc-e063-6394a90ae2f3

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA216814

Listing Expiration 2026-12-31

Marketing Start 2023-03-15

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 855091315

Hyphenated Format 85509-1315

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 ANDA216814 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

26.6 mg/1
800 mg/1

source: ndc

Packaging

30 TABLET in 1 BOTTLE (85509-1315-3)
60 TABLET in 1 BOTTLE (85509-1315-6)
90 TABLET in 1 BOTTLE (85509-1315-9)

source: ndc

Packages (3)

85509-1315-3 30 TABLET in 1 BOTTLE (85509-1315-3) 85509-1315-6 60 TABLET in 1 BOTTLE (85509-1315-6) 85509-1315-9 90 TABLET in 1 BOTTLE (85509-1315-9)

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": "3ff33409-9785-67bc-e063-6394a90ae2f3", "openfda": {"nui": ["N0000000151", "N0000175784", "N0000000160", "M0001335", "N0000175722"], "unii": ["5QZO15J2Z8", "WK2XYI10QM"], "rxcui": ["1100066"], "spl_set_id": ["3ff33400-30e8-87fa-e063-6394a90a7f5c"], "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": ["PHOENIX RX LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (85509-1315-3)", "package_ndc": "85509-1315-3", "marketing_start_date": "20250929"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (85509-1315-6)", "package_ndc": "85509-1315-6", "marketing_start_date": "20250929"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (85509-1315-9)", "package_ndc": "85509-1315-9", "marketing_start_date": "20250929"}], "brand_name": "IBUPROFEN AND FAMOTIDINE", "product_id": "85509-1315_3ff33409-9785-67bc-e063-6394a90ae2f3", "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": "85509-1315", "generic_name": "Ibuprofen and famotidine", "labeler_name": "PHOENIX RX 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": "ANDA216814", "marketing_category": "ANDA", "marketing_start_date": "20230315", "listing_expiration_date": "20261231"}