NDC codes

FDA NDC Directory
Product NDC (as listed)0187-5400Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00187-5400Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0187-5400-02001875400021 BOTTLE, WITH APPLICATOR in 1 CARTON (0187-5400-02) / 2 mL in 1 BOTTLE, WITH APPLICATORMarketed from Dec 17, 2015
0187-5400-04001875400041 BOTTLE, WITH APPLICATOR in 1 CARTON (0187-5400-04) / 4 mL in 1 BOTTLE, WITH APPLICATORMarketed from Jun 6, 2014
0187-5400-08001875400081 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

N400187540002 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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