What is NDC 68791-103?

68791-103 is the product NDC for Dermotic (fluocinolone acetonide), Fluocinolone acetonide .11 mg/mL oil, listed with the FDA by Royal Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Dermotic (Fluocinolone acetonide).

Royal Pharmaceuticals, NDC labeler code 68791. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Dermotic?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Dermotic NDC 68791-103 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68791-103Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68791-0103Add 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
68791-103-20	6879101032068791010320	1 BOTTLE, DROPPER in 1 CARTON (68791-103-20) / 20 mL in 1 BOTTLE, DROPPERMarketed from Nov 9, 2005

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): Dermotic
Generic name (nonproprietary): fluocinolone acetonide
Active ingredients: Fluocinolone acetonide — .11 mg/mL
Dosage form: Oil
Route: Auricular (Otic)
Labeler: Royal PharmaceuticalsNDC labeler code 68791
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 019452
Marketing start: Nov 9, 2005
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 68791-103_195c48d9-bb7a-4c89-b6b8-35fff5aefff8SPL ID 195c48d9-bb7a-4c89-b6b8-35fff5aefff8SPL set ID eb00f222-8105-4e05-90e8-bbd129784364RxCUI 1191299, 1191301UNII 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

N468791010320 followed by a unit qualifier and the quantity

Package 68791-0103-20. 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 May 9, 2025.

Indications (excerpt from the label)

DERMOTIC ® OIL 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 ) DermOtic ® Oil is indicated for the topical treatment of chronic eczematous external otitis in adults and pediatric patients 2 years of age and older.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68791-103

What is NDC 68791-103?: 68791-103 is the product NDC for Dermotic (fluocinolone acetonide), Fluocinolone acetonide .11 mg/mL oil, listed with the FDA by Royal Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Dermotic (Fluocinolone acetonide).
What is the active ingredient?: Fluocinolone acetonide.
Who is the labeler?: Royal Pharmaceuticals, NDC labeler code 68791. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dermotic?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under NDA 019452

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

FDA NDC Directory listings under NDA 019452
Product	Strength	Form · route	Labeler	Product NDC
Derma-Smoothe/FSfluocinolone acetonide	Fluocinolone acetonide .11 mg/mL	OilTopical	Royal Pharmaceuticals, LLC	68791-101
Derma-Smoothe/Fsfluocinolone acetonide	Fluocinolone acetonide .11 mg/mL	OilTopical	Royal Pharmaceuticals	68791-102

Dermotic (Fluocinolone acetonide) NDC 68791-103