Prescription drug · ANDA
Fluocinolone Acetonide NDC 51672-1356
Fluocinolone acetonide .11 mg/118.28mL · Oil · Topical · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51672-1356-8 | 51672135608 | 1 BOTTLE in 1 CARTON (51672-1356-8) / 118.28 mL in 1 BOTTLEMarketed from May 19, 2016 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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/118.28mL
- Dosage form
- Oil
- Route
- Topical
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202368
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 51672-1356_38ef7f42-ef53-5940-e063-6294a90a2fbfSPL ID 38ef7f42-ef53-5940-e063-6294a90a2fbfSPL set ID 22e9909a-47d2-4331-9b92-e7c4c2acf739UNII 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
N451672135608followed by a unit qualifier and the quantityPackage 51672-1356-08. 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)
Fluocinolone acetonide topical oil is a corticosteroid indicated for the topical treatment of atopic dermatitis in adult patients ( 1.1 ) topical treatment of moderate to severe atopic dermatitis in pediatric patients 3 months and older for up to 4 weeks ( 1.2 ) Limitations of Use: Apply the least amount to cover affected areas. Discontinue when disease is controlled. ( 1.3 ) Do not use in the diaper area. ( 1.3 ) Do not use on the face, axillae, or groin. ( 1.3 , 6.2 , 8.4 ) 1.1 Adult Patients with Atopic Dermatitis Fluocinolone acetonide topical oil is indicated for the topical treatment of atopic dermatitis in adult patients. 1.2 Pediatric Patients with Atopic Dermatitis Fluocinolone acet…
Excerpt only. Read the full label for complete information.