jublia

Generic: efinaconazole

Labeler: bausch health us llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name jublia
Generic Name efinaconazole
Labeler bausch health us llc
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

efinaconazole 100 mg/mL

Manufacturer
Bausch Health US LLC

Identifiers & Regulatory

Product NDC 0187-5400
Product ID 0187-5400_aa387108-3f36-49af-bbcb-df681d4b9e51
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA203567
Listing Expiration 2026-12-31
Marketing Start 2014-06-06

Pharmacologic Class

Established (EPC)
azole antifungal [epc]
Chemical Structure
azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01875400
Hyphenated Format 0187-5400

Supplemental Identifiers

RxCUI
1539757 1539762
UNII
J82SB7FXWB
NUI
N0000175487 M0002083

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 jublia (source: ndc)
Generic Name efinaconazole (source: ndc)
Application Number NDA203567 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0187-5400-02) / 2 mL in 1 BOTTLE, WITH APPLICATOR
  • 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0187-5400-04) / 4 mL in 1 BOTTLE, WITH APPLICATOR
  • 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0187-5400-08) / 8 mL in 1 BOTTLE, WITH APPLICATOR
source: ndc

Packages (3)

0187-5400-02 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0187-5400-02) / 2 mL in 1 BOTTLE, WITH APPLICATOR 0187-5400-04 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0187-5400-04) / 4 mL in 1 BOTTLE, WITH APPLICATOR 0187-5400-08 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0187-5400-08) / 8 mL in 1 BOTTLE, WITH APPLICATOR

Ingredients (1)

efinaconazole (100 mg/mL)

Linked Drug Pages (1)

JUBLIA ndc-match (0.9)

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"}