childrens ibuprofen oral suspension (53943-119)

Drug Facts

Product Profile

Brand Name childrens ibuprofen oral suspension

Generic Name ibuprofen

Labeler discount drug mart

Dosage Form SUSPENSION

Routes

ORAL

Active Ingredients

ibuprofen 100 mg/5mL

Manufacturer

Discount Drug Mart

Identifiers & Regulatory

Product NDC 53943-119

Product ID 53943-119_465376e9-bf3f-2a69-e063-6294a90a6a4c

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA210602

Listing Expiration 2026-12-31

Marketing Start 2019-08-16

Pharmacologic Class

Established (EPC)

nonsteroidal anti-inflammatory drug [epc]

Mechanism of Action

cyclooxygenase inhibitors [moa]

Chemical Structure

anti-inflammatory agents, non-steroidal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53943119

Hyphenated Format 53943-119

Supplemental Identifiers

RxCUI

197803

UNII

WK2XYI10QM

NUI

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 childrens ibuprofen oral suspension (source: ndc)

Generic Name ibuprofen (source: ndc)

Application Number ANDA210602 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

100 mg/5mL

source: ndc

Packaging

1 BOTTLE in 1 CARTON (53943-119-24) / 118 mL in 1 BOTTLE

source: ndc

Packages (1)

53943-119-24 1 BOTTLE in 1 CARTON (53943-119-24) / 118 mL in 1 BOTTLE

Ingredients (1)

ibuprofen (100 mg/5mL)

Linked Drug Pages (1)

Childrens Ibuprofen Oral Suspension ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "465376e9-bf3f-2a69-e063-6294a90a6a4c", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["197803"], "spl_set_id": ["7b7954b7-e4c8-4284-a649-31a4eb6ba73e"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Discount Drug Mart"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (53943-119-24)  / 118 mL in 1 BOTTLE", "package_ndc": "53943-119-24", "marketing_start_date": "20190816"}], "brand_name": "Childrens Ibuprofen Oral Suspension", "product_id": "53943-119_465376e9-bf3f-2a69-e063-6294a90a6a4c", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "53943-119", "generic_name": "IBUPROFEN", "labeler_name": "Discount Drug Mart", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens Ibuprofen Oral Suspension", "active_ingredients": [{"name": "IBUPROFEN", "strength": "100 mg/5mL"}], "application_number": "ANDA210602", "marketing_category": "ANDA", "marketing_start_date": "20190816", "listing_expiration_date": "20261231"}