What is NDC 68462-185?

68462-185 is the product NDC for fluocinolone acetonide, Fluocinolone acetonide .11 mg/mL oil, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 1 package NDC, 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 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 68462-185

NDC codes

FDA NDC Directory

Product NDC (as listed)68462-185Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68462-0185Add 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
68462-185-56	6846201855668462018556	1 BOTTLE, DROPPER in 1 CARTON (68462-185-56) / 20 mL in 1 BOTTLE, DROPPERMarketed from Dec 18, 2018

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: Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211815
Marketing start: Dec 18, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 68462-185_cc1f615e-6cb2-4721-84c6-e5f170b64d90SPL ID cc1f615e-6cb2-4721-84c6-e5f170b64d90SPL set ID a00224b0-3db5-4d40-b370-5ec5476e1e10RxCUI 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

N468462018556 followed by a unit qualifier and the quantity

Package 68462-0185-56. 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 18, 2018.

Indications (excerpt from the label)

INDICATION AND USAGE Fluocinolone acetonide oil, 0.01% (ear drops) is a low to medium potency corticosteroid indicated for the treatment of chronic eczematous external otitis in adults and pediatric patients 2 years and older.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68462-185

What is NDC 68462-185?: 68462-185 is the product NDC for fluocinolone acetonide, Fluocinolone acetonide .11 mg/mL oil, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. 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?: 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 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