Package 53041-637-09
Brand: concentrated ibuprofen infants
Generic: ibuprofenPackage Facts
Identity
Package NDC
53041-637-09
Digits Only
5304163709
Product NDC
53041-637
Description
1 BOTTLE in 1 CARTON (53041-637-09) / 30 mL in 1 BOTTLE
Marketing
Marketing Status
Brand
concentrated ibuprofen infants
Generic
ibuprofen
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "d0465832-f323-4ecd-a285-33a8c15eb799", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["204442"], "spl_set_id": ["3a32f0c7-c03e-4783-a429-08280993ddfb"], "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": ["Guardian Drug Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (53041-637-09) / 30 mL in 1 BOTTLE", "package_ndc": "53041-637-09", "marketing_start_date": "20181003"}], "brand_name": "Concentrated ibuprofen infants", "product_id": "53041-637_d0465832-f323-4ecd-a285-33a8c15eb799", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "53041-637", "generic_name": "Ibuprofen", "labeler_name": "Guardian Drug Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Concentrated ibuprofen infants", "active_ingredients": [{"name": "IBUPROFEN", "strength": "50 mg/1.25mL"}], "application_number": "ANDA210755", "marketing_category": "ANDA", "marketing_start_date": "20181003", "listing_expiration_date": "20261231"}