childrens ibuprofen oral suspension

Generic: ibuprofen

Labeler: pai holdings, llc dba pai pharma
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name childrens ibuprofen oral suspension
Generic Name ibuprofen
Labeler pai holdings, llc dba pai pharma
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

ibuprofen 200 mg/10mL

Manufacturer
PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-1666
Product ID 0121-1666_70b3589f-fd88-4a73-b758-0d456422bd27
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA214789
Listing Expiration 2026-12-31
Marketing Start 2025-08-01

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 01211666
Hyphenated Format 0121-1666

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 ANDA214789 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/10mL
source: ndc
Packaging
  • 10 TRAY in 1 CASE (0121-1666-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1666-10)
  • 4 TRAY in 1 CASE (0121-1666-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1666-10)
source: ndc

Packages (2)

0121-1666-00 10 TRAY in 1 CASE (0121-1666-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1666-10) 0121-1666-40 4 TRAY in 1 CASE (0121-1666-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1666-10)

Ingredients (1)

ibuprofen (200 mg/10mL)

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": "70b3589f-fd88-4a73-b758-0d456422bd27", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["197803"], "spl_set_id": ["c26cefe0-182a-4b03-baeb-b3eb2e0e2267"], "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": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TRAY in 1 CASE (0121-1666-00)  / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1666-10)", "package_ndc": "0121-1666-00", "marketing_start_date": "20250801"}, {"sample": false, "description": "4 TRAY in 1 CASE (0121-1666-40)  / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1666-10)", "package_ndc": "0121-1666-40", "marketing_start_date": "20250801"}], "brand_name": "Childrens Ibuprofen Oral Suspension", "product_id": "0121-1666_70b3589f-fd88-4a73-b758-0d456422bd27", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "0121-1666", "generic_name": "Ibuprofen", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens Ibuprofen Oral Suspension", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/10mL"}], "application_number": "ANDA214789", "marketing_category": "ANDA", "marketing_start_date": "20250801", "listing_expiration_date": "20261231"}