What is NDC 45802-009?

45802-009 is the product NDC for Fluocinolone Acetonide, Fluocinolone acetonide .11 mg/mL oil, 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 Fluocinolone Acetonide?

31 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Fluocinolone Acetonide NDC 45802-009

NDC codes

FDA NDC Directory

Product NDC (as listed)45802-009Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45802-0009Add 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
45802-009-10	4580200091045802000910	1 BOTTLE in 1 CARTON (45802-009-10) / 20 mL in 1 BOTTLEMarketed from Oct 4, 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): Fluocinolone Acetonide
Generic name (nonproprietary): fluocinolone acetonide
Active ingredients: Fluocinolone acetonide — .11 mg/mL
Dosage form: Oil
Route: Auricular (Otic)
Labeler: Padagis Israel Pharmaceuticals LtdNDC labeler code 45802
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202849
Marketing start: Oct 4, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 45802-009_8512259d-c8ce-4b9c-ad3b-0d97b9a86077SPL ID 8512259d-c8ce-4b9c-ad3b-0d97b9a86077SPL set ID e6af2549-50b5-4b7f-a0c0-de0f7626b6f3RxCUI 1191299UNII 0CD5FD6S2M
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N445802000910 followed by a unit qualifier and the quantity

Package 45802-0009-10. 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 Jul 31, 2025.

Indications (excerpt from the label)

Fluocinolone acetonide oil ear drops is indicated for the topical treatment of chronic eczematous external otitis in adults and pediatric patients 2 years of age and older. Fluocinolone acetonide oil ear drops is a corticosteroid indicated for the topical treatment of chronic eczematous external otitis in adults and pediatric patients 2 years of age and older. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 45802-009

What is NDC 45802-009?: 45802-009 is the product NDC for Fluocinolone Acetonide, Fluocinolone acetonide .11 mg/mL oil, 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?: Fluocinolone Acetonide.
What is the active ingredient?: Fluocinolone acetonide.
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 Fluocinolone Acetonide?: 31 other product NDCs are listed under this name. See all Fluocinolone Acetonide 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 Fluocinolone Acetonide NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
fluocinolone acetonide	Fluocinolone acetonide .1 mg/g	CreamTopical	ANI Pharmaceuticals, Inc.	62559-288	62559-0288-1562559-0288-60
fluocinolone acetonide	Fluocinolone acetonide .25 mg/g	CreamTopical	ANI Pharmaceuticals, Inc.	62559-289	62559-0289-1562559-0289-60
Fluocinolone Acetonide	Fluocinolone acetonide .25 mg/g	OintmentTopical	ANI Pharmaceuticals, Inc.	62559-299	62559-0299-1562559-0299-60
Fluocinolone Acetonide	Fluocinolone acetonide .11 mg/mL	OilTopical	Quagen Pharmaceuticals LLC	70752-156	70752-0156-06
Fluocinolone Acetonide	Fluocinolone acetonide .11 mg/mL	OilTopical	Quagen Pharmaceuticals LLC	70752-158	70752-0158-06
Fluocinolone Acetonide	Fluocinolone acetonide .11 mg/mL	OilAuricular (Otic)	Quagen Pharmaceuticals LLC	70752-159	70752-0159-20
Fluocinolone Acetonide	Fluocinolone acetonide .11 mg/mL	OilAuricular (Otic)	Bryant Ranch Prepack	71335-2879	71335-2879-01
Fluocinolone Acetonide	Fluocinolone acetonide .11 mg/mL	OilTopical	Bryant Ranch Prepack	71335-2883	71335-2883-01
Fluocinolone Acetonide	Fluocinolone acetonide .11 mg/mL	OilTopical	Bryant Ranch Prepack	71335-2884	71335-2884-01
Fluocinolone Acetonide	Fluocinolone acetonide .11 mg/mL	OilTopical	Bryant Ranch Prepack	72162-2319	72162-2319-02

All 32 Fluocinolone Acetonide NDCs