Prescription drug · NDA
Jublia (Efinaconazole) NDC 0187-5400
Efinaconazole 100 mg/mL · Solution · Topical · Bausch Health US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0187-5400-02 | 00187540002 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0187-5400-02) / 2 mL in 1 BOTTLE, WITH APPLICATORMarketed from Dec 17, 2015 | |
| 0187-5400-04 | 00187540004 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0187-5400-04) / 4 mL in 1 BOTTLE, WITH APPLICATORMarketed from Jun 6, 2014 | |
| 0187-5400-08 | 00187540008 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0187-5400-08) / 8 mL in 1 BOTTLE, WITH APPLICATORMarketed from Jun 6, 2014 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Jublia
- Generic name (nonproprietary)
- efinaconazole
- Active ingredients
- Efinaconazole — 100 mg/mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- Bausch Health US LLCNDC labeler code 0187
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 203567
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)
- Identifiers
- Product ID 0187-5400_aa387108-3f36-49af-bbcb-df681d4b9e51SPL ID aa387108-3f36-49af-bbcb-df681d4b9e51SPL set ID 922d4d25-c530-11e1-9b21-0800200c9a66RxCUI 1539757, 1539762UNII J82SB7FXWB
- Pharmacologic class
- Azole Antifungal
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400187540002followed by a unit qualifier and the quantityPackage 00187-5400-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
JUBLIA (efinaconazole) topical solution, 10% is an azole antifungal indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes . JUBLIA is an azole antifungal indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes . (1)
Excerpt only. Read the full label for complete information.
About NDC 0187-5400
- What is NDC 0187-5400?
- 0187-5400 is the product NDC for Jublia (efinaconazole), Efinaconazole 100 mg/mL solution, listed with the FDA by Bausch Health US LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Jublia (Efinaconazole).
- What is the active ingredient?
- Efinaconazole.
- Who is the labeler?
- Bausch Health US LLC, NDC labeler code 0187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Jublia?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.