Desloratadine NDC 69543-107

NDC codes

FDA NDC Directory

Product NDC (as listed)69543-107Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69543-0107Add 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
69543-107-10	69543010710	100 TABLET in 1 BOTTLE, PLASTIC (69543-107-10)Marketed from Jun 12, 2015
69543-107-50	69543010750	500 TABLET in 1 BOTTLE, PLASTIC (69543-107-50)Marketed from Jun 12, 2015

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): Desloratadine
Generic name (nonproprietary): desloratadine
Active ingredients: Desloratadine — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Virtus Pharmaceuticals, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078355
Marketing start: Jun 12, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 69543-107_7c658c72-2694-49dd-9950-0aed03e3d7dcSPL ID 7c658c72-2694-49dd-9950-0aed03e3d7dcSPL set ID 0fe374d0-c14b-4102-b568-eb79165fc7efRxCUI 349420UNII FVF865388R
Pharmacologic class: Histamine-1 Receptor Antagonist

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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N469543010710 followed by a unit qualifier and the quantity

Package 69543-0107-10. 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 Jul 10, 2025.

Indications (excerpt from the label)

Desloratadine Tablets are a histamine-1 (H1) receptor antagonist indicated for: • Seasonal Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 12 years of age and older. ( 1.1 ) • Perennial Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 12 years of age and older. ( 1.2 ) • Chronic Idiopathic Urticaria: symptomatic relief of pruritus, reduction in the number of hives, and size of hives in patients 12 years of age and older. ( 1.3 ) 1.1 Seasonal Allergic Rhinitis Desloratadine Tablets are indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis in patients 12 years of age and older. 1.2 Perennial Allergic Rhinitis Deslo…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078355

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

FDA NDC Directory listings under ANDA 078355
Product	Strength	Form · route	Labeler	Product NDC
Desloratadine	Desloratadine 5 mg/1	TabletOral	Morepen Bio Inc.	87717-001
Desloratadine	Desloratadine 5 mg/1	TabletOral	Bryant Ranch Prepack	72162-2308
Desloratadine	Desloratadine 5 mg/1	TabletOral	A-S Medication Solutions	50090-3975