What is NDC 43386-026?

43386-026 is the product NDC for Fluocinonide, Fluocinonide .5 mg/mL solution, listed with the FDA by Lupin Pharmaceuticals,Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Lupin Pharmaceuticals,Inc., NDC labeler code 43386. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Fluocinonide?

50 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Fluocinonide NDC 43386-026 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43386-026Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43386-0026Add 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 NDC	11-digit (billing)	Package	Copy
43386-026-02	4338600260243386002602	1 BOTTLE in 1 CARTON (43386-026-02) / 20 mL in 1 BOTTLEMarketed from Jul 21, 2017
43386-026-06	4338600260643386002606	1 BOTTLE in 1 CARTON (43386-026-06) / 60 mL in 1 BOTTLEMarketed from Jul 21, 2017

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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): Fluocinonide
Generic name (nonproprietary): fluocinonide
Active ingredients: Fluocinonide — .5 mg/mL
Dosage form: Solution
Route: Topical
Labeler: Lupin Pharmaceuticals,Inc.NDC labeler code 43386
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206003
Marketing start: Jul 21, 2017
Listing expires: Dec 31, 2027
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 43386-026_465101b9-6374-4ce8-b64d-97e296f5c72aSPL ID 465101b9-6374-4ce8-b64d-97e296f5c72aSPL set ID 43b7621c-6628-4b54-af32-32efd0f722daRxCUI 310364UNII 2W4A77YPAN
Pharmacologic class: Corticosteroid

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

N443386002602 followed by a unit qualifier and the quantity

Package 43386-0026-02. 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 Dec 20, 2018.

Indications (excerpt from the label)

INDICATIONS AND USAGE Fluocinonide Topical Solution USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43386-026

What is NDC 43386-026?: 43386-026 is the product NDC for Fluocinonide, Fluocinonide .5 mg/mL solution, listed with the FDA by Lupin Pharmaceuticals,Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Fluocinonide.
What is the active ingredient?: Fluocinonide.
Who is the labeler?: Lupin Pharmaceuticals,Inc., NDC labeler code 43386. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Fluocinonide?: 50 other product NDCs are listed under this name. See all Fluocinonide NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Fluocinonide NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Fluocinonide	Fluocinonide .5 mg/mL	SolutionTopical	Saptalis Pharmaceuticals, LLC.	71656-094	71656-0094-2071656-0094-60
Fluocinonide	Fluocinonide .5 mg/mL	SolutionTopical	NorthStar RxLLC	72603-703	72603-0703-01
Fluocinonide	Fluocinonide .5 mg/mL	SolutionTopical	Bryant Ranch Prepack	72162-2490	72162-2490-0272162-2490-06
Fluocinonide	Fluocinonide .5 mg/g	GelTopical	Padagis Israel Pharmaceuticals Ltd	45802-761	45802-0761-1545802-0761-3045802-0761-60
Fluocinonide	Fluocinonide .5 mg/mL	SolutionTopical	QUAGEN PHARMACEUTICALS LLC	70752-154	70752-0154-05
Fluocinonide	Fluocinonide .5 mg/g	CreamTopical	Encube Ethicals, Inc.	21922-064	21922-0064-0321922-0064-0421922-0064-05+1 more
Fluocinonide	Fluocinonide .5 mg/g	CreamTopical	Preferred Pharmaceuticals Inc.	68788-8593	68788-8593-0368788-8593-06
Fluocinonide	Fluocinonide .5 mg/g	OintmentTopical	Preferred Pharmaceuticals Inc.	68788-8554	68788-8554-06
Fluocinonide	Fluocinonide .5 mg/g	CreamTopical	Cosette Pharmaceuticals, Inc.	0713-0663	00713-0663-1500713-0663-3100713-0663-60
Fluocinonide	Fluocinonide 1 mg/g	CreamTopical	Viona Pharmaceuticals Inc	72578-087	72578-0087-0272578-0087-0672578-0087-07

All 51 Fluocinonide NDCs

Other NDCs under ANDA 206003

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 206003
Product	Strength	Form · route	Labeler	Product NDC
fluocinonide	Fluocinonide .5 mg/mL	SolutionTopical	Novel Laboratories, Inc.	40032-026