Prescription drug · NDA
Synalar (fluocinolone acetonide) NDC 43538-900
Fluocinolone acetonide .25 mg/g · Cream · Topical · Medimetriks Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43538-900-12 | 43538090012 | 1 TUBE in 1 CARTON (43538-900-12) / 120 g in 1 TUBEMarketed from Sep 27, 2012 |
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)
- Synalar
- Generic name (nonproprietary)
- fluocinolone acetonide
- Active ingredients
- Fluocinolone acetonide — .25 mg/g
- Dosage form
- Cream
- Route
- Topical
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 012787
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 43538-900_890554e0-30dd-4f2c-a469-f8822ca89cabSPL ID 890554e0-30dd-4f2c-a469-f8822ca89cabSPL set ID 5af2e4c1-082b-48a0-aae7-72d4a68cbb2dRxCUI 1191315, 1191319UNII 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
N443538090012followed by a unit qualifier and the quantityPackage 43538-0900-12. 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)
INDICATIONS AND USAGE SYNALAR ® Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteriod-responsive dermatoses.
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 012787
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 |
|---|---|---|---|---|
| fluocinolone acetonide | Fluocinolone acetonide .1 mg/g | CreamTopical | ANI Pharmaceuticals, Inc. | 62559-288 |
| fluocinolone acetonide | Fluocinolone acetonide .25 mg/g | CreamTopical | ANI Pharmaceuticals, Inc. | 62559-289 |