Package 0187-5400-02
Brand: jublia
Generic: efinaconazolePackage Facts
Identity
Package NDC
0187-5400-02
Digits Only
0187540002
Product NDC
0187-5400
Description
1 BOTTLE, WITH APPLICATOR in 1 CARTON (0187-5400-02) / 2 mL in 1 BOTTLE, WITH APPLICATOR
Marketing
Marketing Status
Brand
jublia
Generic
efinaconazole
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["TOPICAL"], "spl_id": "aa387108-3f36-49af-bbcb-df681d4b9e51", "openfda": {"nui": ["N0000175487", "M0002083"], "unii": ["J82SB7FXWB"], "rxcui": ["1539757", "1539762"], "spl_set_id": ["922d4d25-c530-11e1-9b21-0800200c9a66"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Bausch Health US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (0187-5400-02) / 2 mL in 1 BOTTLE, WITH APPLICATOR", "package_ndc": "0187-5400-02", "marketing_start_date": "20151217"}, {"sample": false, "description": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (0187-5400-04) / 4 mL in 1 BOTTLE, WITH APPLICATOR", "package_ndc": "0187-5400-04", "marketing_start_date": "20140606"}, {"sample": false, "description": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (0187-5400-08) / 8 mL in 1 BOTTLE, WITH APPLICATOR", "package_ndc": "0187-5400-08", "marketing_start_date": "20140606"}], "brand_name": "JUBLIA", "product_id": "0187-5400_aa387108-3f36-49af-bbcb-df681d4b9e51", "dosage_form": "SOLUTION", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "0187-5400", "generic_name": "efinaconazole", "labeler_name": "Bausch Health US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "JUBLIA", "active_ingredients": [{"name": "EFINACONAZOLE", "strength": "100 mg/mL"}], "application_number": "NDA203567", "marketing_category": "NDA", "marketing_start_date": "20140606", "listing_expiration_date": "20261231"}