infants ibuprofen

Generic: ibuprofen

Labeler: walgreens
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name infants ibuprofen
Generic Name ibuprofen
Labeler walgreens
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

ibuprofen 50 mg/1.25mL

Manufacturer
Walgreens

Identifiers & Regulatory

Product NDC 0363-5100
Product ID 0363-5100_5d8f5b4b-811f-492f-a195-0205db857158
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA079058
Marketing Start 2020-12-04
Marketing End 2027-03-01

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 03635100
Hyphenated Format 0363-5100

Supplemental Identifiers

RxCUI
204442
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 infants ibuprofen (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number ANDA079058 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1.25mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0363-5100-01) / 30 mL in 1 BOTTLE
source: ndc

Packages (1)

0363-5100-01 1 BOTTLE in 1 CARTON (0363-5100-01) / 30 mL in 1 BOTTLE

Ingredients (1)

ibuprofen (50 mg/1.25mL)

Linked Drug Pages (1)

Infants Ibuprofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5d8f5b4b-811f-492f-a195-0205db857158", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["204442"], "spl_set_id": ["3bbbe142-a00c-404b-a116-81ad730ea130"], "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": ["Walgreens"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0363-5100-01)  / 30 mL in 1 BOTTLE", "package_ndc": "0363-5100-01", "marketing_end_date": "20270301", "marketing_start_date": "20201204"}], "brand_name": "Infants Ibuprofen", "product_id": "0363-5100_5d8f5b4b-811f-492f-a195-0205db857158", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "0363-5100", "generic_name": "Ibuprofen", "labeler_name": "Walgreens", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Infants Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "50 mg/1.25mL"}], "application_number": "ANDA079058", "marketing_category": "ANDA", "marketing_end_date": "20270301", "marketing_start_date": "20201204"}