Synalar (fluocinolone acetonide) NDC 43538-900

NDC codes

FDA NDC Directory

Product NDC (as listed)43538-900Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43538-0900Add 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
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
Labeler: Medimetriks Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 012787
Marketing start: Sep 27, 2012
Listing expires: Dec 31, 2026
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

N443538090012 followed by a unit qualifier and the quantity

Package 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

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

Other NDCs under NDA 012787

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 012787
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