childrens ibuprofen (81033-019)

Drug Facts

Product Profile

Brand Name childrens ibuprofen

Generic Name ibuprofen

Labeler kesin pharma corporation

Dosage Form SUSPENSION

Routes

ORAL

Active Ingredients

ibuprofen 100 mg/5mL

Manufacturer

Kesin Pharma Corporation

Identifiers & Regulatory

Product NDC 81033-019

Product ID 81033-019_436c00d4-44ed-b9a9-e063-6294a90a9448

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA074937

Listing Expiration 2026-12-31

Marketing Start 2011-04-28

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 81033019

Hyphenated Format 81033-019

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 (source: ndc)

Generic Name ibuprofen (source: ndc)

Application Number ANDA074937 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

100 mg/5mL

source: ndc

Packaging

100 CUP, UNIT-DOSE in 1 CASE (81033-019-01) / 5 mL in 1 CUP, UNIT-DOSE (81033-019-05)
100 CUP, UNIT-DOSE in 1 CASE (81033-019-02) / 10 mL in 1 CUP, UNIT-DOSE (81033-019-10)

source: ndc

Packages (2)

81033-019-01 100 CUP, UNIT-DOSE in 1 CASE (81033-019-01) / 5 mL in 1 CUP, UNIT-DOSE (81033-019-05) 81033-019-02 100 CUP, UNIT-DOSE in 1 CASE (81033-019-02) / 10 mL in 1 CUP, UNIT-DOSE (81033-019-10)

Ingredients (1)

ibuprofen (100 mg/5mL)

Linked Drug Pages (1)

CHILDRENS Ibuprofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "436c00d4-44ed-b9a9-e063-6294a90a9448", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["197803"], "spl_set_id": ["436c0126-4ff3-c082-e063-6294a90a3d72"], "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": ["Kesin Pharma Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CUP, UNIT-DOSE in 1 CASE (81033-019-01)  / 5 mL in 1 CUP, UNIT-DOSE (81033-019-05)", "package_ndc": "81033-019-01", "marketing_start_date": "20251101"}, {"sample": false, "description": "100 CUP, UNIT-DOSE in 1 CASE (81033-019-02)  / 10 mL in 1 CUP, UNIT-DOSE (81033-019-10)", "package_ndc": "81033-019-02", "marketing_start_date": "20251101"}], "brand_name": "CHILDRENS Ibuprofen", "product_id": "81033-019_436c00d4-44ed-b9a9-e063-6294a90a9448", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "81033-019", "generic_name": "Ibuprofen", "labeler_name": "Kesin Pharma Corporation", "product_type": "HUMAN OTC DRUG", "brand_name_base": "CHILDRENS Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "100 mg/5mL"}], "application_number": "ANDA074937", "marketing_category": "ANDA", "marketing_start_date": "20110428", "listing_expiration_date": "20261231"}