Derma-Smoothe/FS (fluocinolone acetonide) NDC 68791-101

NDC codes

FDA NDC Directory

Product NDC (as listed)68791-101Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68791-0101Add 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
68791-101-04	68791010104	1 BOTTLE in 1 CARTON (68791-101-04) / 118.28 mL in 1 BOTTLEMarketed from Feb 16, 1995

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): Derma-Smoothe/FS
Generic name (nonproprietary): fluocinolone acetonide
Active ingredients: Fluocinolone acetonide — .11 mg/mL
Dosage form: Oil
Route: Topical
Labeler: Royal Pharmaceuticals, LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 019452
Marketing start: Feb 16, 1995
Listing expires: Dec 31, 2027
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 68791-101_53d4d10c-ef0e-425a-e063-6394a90af06cSPL ID 53d4d10c-ef0e-425a-e063-6394a90af06cSPL set ID bc61c619-a71c-46f5-80f1-9e9ee71134aaRxCUI 1191307, 1191309UNII 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 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

N468791010104 followed by a unit qualifier and the quantity

Package 68791-0101-04. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

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
Dermoticfluocinolone acetonide	Fluocinolone acetonide .11 mg/mL	OilAuricular (Otic)	Royal Pharmaceuticals	68791-103
Derma-Smoothe/Fsfluocinolone acetonide	Fluocinolone acetonide .11 mg/mL	OilTopical	Royal Pharmaceuticals	68791-102