topcare infants ibuprofen

Generic: ibuprofen

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name topcare infants ibuprofen
Generic Name ibuprofen
Labeler topco associates llc
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

ibuprofen 50 mg/1.25mL

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-057
Product ID 36800-057_f581be63-9628-433f-8a31-eba6f530254e
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA075217
Listing Expiration 2026-12-31
Marketing Start 2002-01-22

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 36800057
Hyphenated Format 36800-057

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 topcare infants ibuprofen (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number ANDA075217 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1.25mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (36800-057-05) / 15 mL in 1 BOTTLE
source: ndc

Packages (1)

36800-057-05 1 BOTTLE in 1 CARTON (36800-057-05) / 15 mL in 1 BOTTLE

Ingredients (1)

ibuprofen (50 mg/1.25mL)

Linked Drug Pages (1)

Topcare Infants Ibuprofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f581be63-9628-433f-8a31-eba6f530254e", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["204442"], "spl_set_id": ["00d33273-e8c7-4d40-8e6f-a980f746fff2"], "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": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-057-05)  / 15 mL in 1 BOTTLE", "package_ndc": "36800-057-05", "marketing_start_date": "20020122"}], "brand_name": "Topcare Infants Ibuprofen", "product_id": "36800-057_f581be63-9628-433f-8a31-eba6f530254e", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "36800-057", "generic_name": "ibuprofen", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Topcare Infants Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "50 mg/1.25mL"}], "application_number": "ANDA075217", "marketing_category": "ANDA", "marketing_start_date": "20020122", "listing_expiration_date": "20261231"}