What is NDC 68462-505?

68462-505 is the product NDC for Fluocinonide, Fluocinonide 1 mg/g cream, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 3 package NDCs, shown above in 10- and 11-digit form.

Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. 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 68462-505 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68462-505Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68462-0505Add 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
68462-505-35	6846205053568462050535	30 g in 1 TUBE (68462-505-35)Marketed from Jul 14, 2014
68462-505-65	6846205056568462050565	60 g in 1 TUBE (68462-505-65)Marketed from Jul 14, 2014
68462-505-66	6846205056668462050566	120 g in 1 TUBE (68462-505-66)Marketed from Jul 14, 2014

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 — 1 mg/g
Dosage form: Cream
Route: Topical
Labeler: Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091282
Marketing start: Jul 14, 2014
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 68462-505_9c6c8ea8-4836-4bb8-882b-2375184485d2SPL ID 9c6c8ea8-4836-4bb8-882b-2375184485d2SPL set ID 50f1c216-78c6-4b93-b732-b3beeb78bd62RxCUI 485647UNII 2W4A77YPANUPC 0368462505656
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

N468462050535 followed by a unit qualifier and the quantity

Package 68462-0505-35. 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 Sep 30, 2014.

Indications (excerpt from the label)

Fluocinonide cream USP, 0.1%is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older. ( 1 ) Limitation of Use: • Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. ( 1 ) • Avoid use on the face, groin, or axillae. ( 1.2 ) • Avoid use in perioral dermatitis or rosacea. 1.1 Indication Fluocinonide cream USP, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68462-505

What is NDC 68462-505?: 68462-505 is the product NDC for Fluocinonide, Fluocinonide 1 mg/g cream, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. 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?: Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. 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