What is NDC 0713-0663?

0713-0663 is the product NDC for Fluocinonide, Fluocinonide .5 mg/g cream, listed with the FDA by Cosette Pharmaceuticals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Cosette Pharmaceuticals, Inc., NDC labeler code 0713. 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 0713-0663 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0713-0663Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00713-0663Add 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
0713-0663-15	0071306631500713066315	1 TUBE in 1 CARTON (0713-0663-15) / 15 g in 1 TUBEMarketed from Nov 16, 2022
0713-0663-31	0071306633100713066331	1 TUBE in 1 CARTON (0713-0663-31) / 30 g in 1 TUBEMarketed from Nov 16, 2022
0713-0663-60	0071306636000713066360	1 TUBE in 1 CARTON (0713-0663-60) / 60 g in 1 TUBEMarketed from Nov 16, 2022

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): Fluocinonide
Generic name (nonproprietary): fluocinonide
Active ingredients: Fluocinonide — .5 mg/g
Dosage form: Cream
Route: Topical
Labeler: Cosette Pharmaceuticals, Inc.NDC labeler code 0713
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 073085
Marketing start: Nov 16, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 0713-0663_f0d2ff2b-732c-ae99-e053-2995a90a1ee7SPL ID f0d2ff2b-732c-ae99-e053-2995a90a1ee7SPL set ID e3348b90-8c16-4788-ab61-e354aea5d0a8RxCUI 103456UNII 2W4A77YPANUPC 0307130663311, 0307130663151
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

N400713066315 followed by a unit qualifier and the quantity

Package 00713-0663-15. 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 27, 2022.

Indications (excerpt from the label)

INDICATIONS AND USAGE Fluocinonide Cream, 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 0713-0663

What is NDC 0713-0663?: 0713-0663 is the product NDC for Fluocinonide, Fluocinonide .5 mg/g cream, listed with the FDA by Cosette Pharmaceuticals, Inc.. It has 3 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?: Cosette Pharmaceuticals, Inc., NDC labeler code 0713. 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 1 mg/g	CreamTopical	Viona Pharmaceuticals Inc	72578-087	72578-0087-0272578-0087-0672578-0087-07
Fluocinonide	Fluocinonide 1 mg/g	CreamTopical	Zydus Lifesciences Limited	70771-1393	70771-1393-0270771-1393-0370771-1393-05

All 51 Fluocinonide NDCs

Other NDCs under ANDA 073085

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

FDA NDC Directory listings under ANDA 073085
Product	Strength	Form · route	Labeler	Product NDC
Fluocinonide	Fluocinonide .5 mg/g	CreamTopical	Preferred Pharmaceuticals Inc.	68788-8593