Prescription drug · NDA
Derma-Smoothe/FS (Fluocinolone acetonide) NDC 68791-101
Fluocinolone acetonide .11 mg/mL · Oil · Topical · Royal Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68791-101-04 | 6879101010468791010104 | 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, LLCNDC labeler code 68791
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019452
- Marketing start
- Listing expires
- 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
N468791010104followed by a unit qualifier and the quantityPackage 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
DERMA-SMOOTHE/FS Body Oil is a corticosteroid indicated for the topical treatment of: • atopic dermatitis in adults (1) • moderate to severe atopic dermatitis in pediatric patients 3 months of age and older (1) Derma-Smoothe/FS ® Body Oil is indicated for the topical treatment of: • atopic dermatitis in adults • moderate to severe atopic dermatitis in pediatric patients 3 months of age and older
Excerpt only. Read the full label for complete information.
About NDC 68791-101
- What is NDC 68791-101?
- 68791-101 is the product NDC for Derma-Smoothe/FS (fluocinolone acetonide), Fluocinolone acetonide .11 mg/mL oil, listed with the FDA by Royal Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Derma-Smoothe/FS (Fluocinolone acetonide).
- What is the active ingredient?
- Fluocinolone acetonide.
- Who is the labeler?
- Royal Pharmaceuticals, LLC, 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 Derma-Smoothe/FS?
- 1 other product NDC are listed under this name. See all Derma-Smoothe/FS NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Derma-Smoothe/FS products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Derma-Smoothe/Fsfluocinolone acetonide | Fluocinolone acetonide .11 mg/mL | OilTopical | Royal Pharmaceuticals | 68791-102 | 68791-0102-04 |
Other NDCs under NDA 019452
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Derma-Smoothe/Fsfluocinolone acetonide | Fluocinolone acetonide .11 mg/mL | OilTopical | Royal Pharmaceuticals | 68791-102 |
| Dermoticfluocinolone acetonide | Fluocinolone acetonide .11 mg/mL | OilAuricular (Otic) | Royal Pharmaceuticals | 68791-103 |