Prescription drug · NDA
Synalar (Fluocinolone acetonide) NDC 43538-910
Fluocinolone acetonide .25 mg/g · Ointment · Topical · Medimetriks Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43538-910-12 | 4353809101243538091012 | 1 TUBE in 1 CARTON (43538-910-12) / 120 g in 1 TUBEMarketed from Sep 27, 2012 | |
| 43538-910-99 | 4353809109943538091099 | 6 TUBE in 1 CARTON (43538-910-99) / 3 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
- Ointment
- Route
- Topical
- Labeler
- Medimetriks Pharmaceuticals, Inc.NDC labeler code 43538
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 013960
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 43538-910_ba6591f7-ccd9-4269-a18f-d269f2714345SPL ID ba6591f7-ccd9-4269-a18f-d269f2714345SPL set ID d2d155cf-a635-4ab7-87de-34e90b9a74cdRxCUI 1191256, 1191260UNII 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
N443538091012followed by a unit qualifier and the quantityPackage 43538-0910-12. 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 ® Ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteriod-responsive dermatoses.
Excerpt only. Read the full label for complete information.
About NDC 43538-910
- What is NDC 43538-910?
- 43538-910 is the product NDC for Synalar (fluocinolone acetonide), Fluocinolone acetonide .25 mg/g ointment, listed with the FDA by Medimetriks Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Synalar (Fluocinolone acetonide).
- What is the active ingredient?
- Fluocinolone acetonide.
- Who is the labeler?
- Medimetriks Pharmaceuticals, Inc., NDC labeler code 43538. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Synalar?
- 1 other product NDC are listed under this name. See all Synalar NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Synalar products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Synalarfluocinolone acetonide | Fluocinolone acetonide .25 mg/g | CreamTopical | Medimetriks Pharmaceuticals, Inc. | 43538-900 | 43538-0900-12 |
Other NDCs under NDA 013960
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 .25 mg/g | OintmentTopical | ANI Pharmaceuticals, Inc. | 62559-299 |