childrens ibuprofen oral suspension original berry flavor

Generic: ibuprofen

Labeler: puro pharma inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name childrens ibuprofen oral suspension original berry flavor
Generic Name ibuprofen
Labeler puro pharma inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

ibuprofen 100 mg/5mL

Manufacturer
Puro Pharma Inc.

Identifiers & Regulatory

Product NDC 83474-002
Product ID 83474-002_46f2db1a-4830-abd1-e063-6394a90a735f
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210602
Listing Expiration 2026-12-31
Marketing Start 2024-03-28

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 83474002
Hyphenated Format 83474-002

Supplemental Identifiers

RxCUI
197803
UPC
0383474002047
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 original berry flavor (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 (83474-002-04) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

83474-002-04 1 BOTTLE in 1 CARTON (83474-002-04) / 118 mL in 1 BOTTLE

Ingredients (1)

ibuprofen (100 mg/5mL)

Linked Drug Pages (1)

Childrens Ibuprofen Oral Suspension Original Berry Flavor ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "46f2db1a-4830-abd1-e063-6394a90a735f", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0383474002047"], "unii": ["WK2XYI10QM"], "rxcui": ["197803"], "spl_set_id": ["6b993b25-9c81-4d75-b332-6de3f6c3b4c9"], "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": ["Puro Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (83474-002-04)  / 118 mL in 1 BOTTLE", "package_ndc": "83474-002-04", "marketing_start_date": "20240328"}], "brand_name": "Childrens Ibuprofen Oral Suspension Original Berry Flavor", "product_id": "83474-002_46f2db1a-4830-abd1-e063-6394a90a735f", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "83474-002", "generic_name": "IBUPROFEN", "labeler_name": "Puro Pharma Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens Ibuprofen Oral Suspension Original Berry Flavor", "active_ingredients": [{"name": "IBUPROFEN", "strength": "100 mg/5mL"}], "application_number": "ANDA210602", "marketing_category": "ANDA", "marketing_start_date": "20240328", "listing_expiration_date": "20261231"}