Clarinex (desloratadine) NDC 78206-188

NDC codes

FDA NDC Directory

Product NDC (as listed)78206-188Labeler and product segments. Claims need a package NDC.

Product NDC at billing width78206-0188Add 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
78206-188-01	78206018801	100 TABLET, FILM COATED in 1 BOTTLE (78206-188-01)Marketed from Aug 23, 2022

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): Clarinex
Generic name (nonproprietary): desloratadine
Active ingredients: Desloratadine — 5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Organon LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 021165
Marketing start: Aug 23, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 78206-188_6ec783d3-9308-4f6b-bfda-b41888b95102SPL ID 6ec783d3-9308-4f6b-bfda-b41888b95102SPL set ID c671342e-69a2-4ca5-abc2-8166ed4240d4RxCUI 349420, 352086UNII FVF865388RUPC 0378206188014, 0378206119018
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

N478206018801 followed by a unit qualifier and the quantity

Package 78206-0188-01. 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 May 17, 2025.

Indications (excerpt from the label)

CLARINEX is a histamine-1 (H1) receptor antagonist indicated for: Seasonal Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 2 years of age and older. ( 1.1 ) Perennial Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 6 months 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 6 months of age and older. ( 1.3 ) 1.1 Seasonal Allergic Rhinitis CLARINEX ® is indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis in patients 2 years of age and older. 1.2 Perennial Allergic Rhinitis CLARINEX is indicated for the relief of…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 021165

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

FDA NDC Directory listings under NDA 021165
Product	Strength	Form · route	Labeler	Product NDC
Clarinexdesloratadine	Desloratadine 5 mg/1	Tablet, Film coatedOral	Organon LLC	78206-119