dye free childrens ibuprofen

Generic: ibuprofen

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

Drug Facts

Product Profile

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

ibuprofen 100 mg/5mL

Manufacturer
PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-1022
Product ID 0121-1022_d1635350-9966-4795-9bc2-6cf2b690eaec
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210602
Listing Expiration 2026-12-31
Marketing Start 2023-11-03

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 01211022
Hyphenated Format 0121-1022

Supplemental Identifiers

RxCUI
197803
UNII
WK2XYI10QM
NUI
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 dye free childrens ibuprofen (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
  • 10 CUP, UNIT-DOSE in 1 CASE (0121-1022-00) / 5 mL in 1 CUP, UNIT-DOSE
  • 10 CUP, UNIT-DOSE in 1 TRAY (0121-1022-05) / 5 mL in 1 CUP, UNIT-DOSE
source: ndc

Packages (2)

0121-1022-00 10 CUP, UNIT-DOSE in 1 CASE (0121-1022-00) / 5 mL in 1 CUP, UNIT-DOSE 0121-1022-05 10 CUP, UNIT-DOSE in 1 TRAY (0121-1022-05) / 5 mL in 1 CUP, UNIT-DOSE

Ingredients (1)

ibuprofen (100 mg/5mL)

Linked Drug Pages (1)

Dye Free Childrens Ibuprofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d1635350-9966-4795-9bc2-6cf2b690eaec", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["197803"], "spl_set_id": ["a616a7cd-4814-478e-8c58-7fbc2454d992"], "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"]}, "finished": true, "packaging": [{"sample": false, "description": "10 CUP, UNIT-DOSE in 1 CASE (0121-1022-00)  / 5 mL in 1 CUP, UNIT-DOSE", "package_ndc": "0121-1022-00", "marketing_start_date": "20231103"}, {"sample": false, "description": "10 CUP, UNIT-DOSE in 1 TRAY (0121-1022-05)  / 5 mL in 1 CUP, UNIT-DOSE", "package_ndc": "0121-1022-05", "marketing_start_date": "20231103"}], "brand_name": "Dye Free Childrens Ibuprofen", "product_id": "0121-1022_d1635350-9966-4795-9bc2-6cf2b690eaec", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "0121-1022", "generic_name": "Ibuprofen", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Dye Free Childrens Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "100 mg/5mL"}], "application_number": "ANDA210602", "marketing_category": "ANDA", "marketing_start_date": "20231103", "listing_expiration_date": "20261231"}