What is NDC 45802-928?

45802-928 is the product NDC for Flurandrenolide, Flurandrenolide .5 mg/mL lotion, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.

Padagis Israel Pharmaceuticals Ltd, NDC labeler code 45802. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Flurandrenolide?

2 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Flurandrenolide NDC 45802-928 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)45802-928Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45802-0928Add 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
45802-928-03	4580209280345802092803	120 mL in 1 BOTTLE, PLASTIC (45802-928-03)Marketed from Oct 6, 2016

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): Flurandrenolide
Generic name (nonproprietary): flurandrenolide
Active ingredients: Flurandrenolide — .5 mg/mL
Dosage form: Lotion
Route: Topical
Labeler: Padagis Israel Pharmaceuticals LtdNDC labeler code 45802
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207133
Marketing start: Oct 6, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 45802-928_a5be325d-6006-40c1-bace-5adcf29548e5SPL ID a5be325d-6006-40c1-bace-5adcf29548e5SPL set ID 9c4f5aea-2e08-400c-88f6-d9e3013afda7RxCUI 197719UNII 8EUL29XUQT
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

N445802092803 followed by a unit qualifier and the quantity

Package 45802-0928-03. 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 Oct 11, 2022.

Indications (excerpt from the label)

INDICATIONS AND USAGE Flurandrenolide Lotion 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 45802-928

What is NDC 45802-928?: 45802-928 is the product NDC for Flurandrenolide, Flurandrenolide .5 mg/mL lotion, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Flurandrenolide.
What is the active ingredient?: Flurandrenolide.
Who is the labeler?: Padagis Israel Pharmaceuticals Ltd, NDC labeler code 45802. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Flurandrenolide?: 2 other product NDCs are listed under this name. See all Flurandrenolide 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 Flurandrenolide NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Flurandrenolide	Flurandrenolide .5 mg/mL	LotionTopical	Bryant Ranch Prepack	63629-8657	63629-8657-01
Flurandrenolide	Flurandrenolide .5 mg/mL	LotionTopical	Bryant Ranch Prepack	72162-1439	72162-1439-02

Other NDCs under ANDA 207133

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

FDA NDC Directory listings under ANDA 207133
Product	Strength	Form · route	Labeler	Product NDC
Flurandrenolide	Flurandrenolide .5 mg/mL	LotionTopical	Bryant Ranch Prepack	63629-8657
Flurandrenolide	Flurandrenolide .5 mg/mL	LotionTopical	Bryant Ranch Prepack	72162-1439