ibuprofen and famotidine (43602-544)

Drug Facts

Product Profile

Brand Name ibuprofen and famotidine

Generic Name ibuprofen and famotidine

Labeler ascent pharmaceuticals, inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

famotidine 26.6 mg/1, ibuprofen 800 mg/1

Manufacturer

Ascent Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43602-544

Product ID 43602-544_97d403fb-8a67-483d-8f9c-45dd16a31689

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA216814

Listing Expiration 2026-12-31

Marketing Start 2022-10-06

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 43602544

Hyphenated Format 43602-544

Supplemental Identifiers

UPC

0343602544306

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 ANDA216814 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

26.6 mg/1
800 mg/1

source: ndc

Packaging

500 TABLET in 1 BOTTLE (43602-544-05)
30 TABLET in 1 BOTTLE (43602-544-30)
90 TABLET in 1 BOTTLE (43602-544-90)

source: ndc

Packages (3)

43602-544-05 500 TABLET in 1 BOTTLE (43602-544-05) 43602-544-30 30 TABLET in 1 BOTTLE (43602-544-30) 43602-544-90 90 TABLET in 1 BOTTLE (43602-544-90)

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": "97d403fb-8a67-483d-8f9c-45dd16a31689", "openfda": {"nui": ["N0000000151", "N0000175784", "N0000000160", "M0001335", "N0000175722"], "upc": ["0343602544306"], "unii": ["5QZO15J2Z8", "WK2XYI10QM"], "spl_set_id": ["03733e49-7db4-4d98-b363-d0d23686ec72"], "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": ["Ascent Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (43602-544-05)", "package_ndc": "43602-544-05", "marketing_start_date": "20221006"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (43602-544-30)", "package_ndc": "43602-544-30", "marketing_start_date": "20221006"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (43602-544-90)", "package_ndc": "43602-544-90", "marketing_start_date": "20221006"}], "brand_name": "IBUPROFEN AND FAMOTIDINE", "product_id": "43602-544_97d403fb-8a67-483d-8f9c-45dd16a31689", "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": "43602-544", "generic_name": "Ibuprofen and famotidine", "labeler_name": "Ascent 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": "ANDA216814", "marketing_category": "ANDA", "marketing_start_date": "20221006", "listing_expiration_date": "20261231"}