Dymista NDC 0037-0245

NDC codes

FDA NDC Directory

Product NDC (as listed)0037-0245Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00037-0245Add 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
0037-0245-23	00037024523	1 BOTTLE, SPRAY in 1 BOX (0037-0245-23) / 120 SPRAY, METERED in 1 BOTTLE, SPRAYMarketed from Oct 1, 2016

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Dymista
Generic name (nonproprietary): azelastine hydrochloride and fluticasone propionate
Active ingredients: Azelastine hydrochloride — 137 ug/1Fluticasone propionate — 50 ug/1
Dosage form: Spray, Metered
Route: Nasal
Labeler: Viatris Specialty LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 202236
Marketing start: Oct 1, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 0037-0245_ed1f7ce9-ccfa-4e73-940f-14ea8166d524SPL ID ed1f7ce9-ccfa-4e73-940f-14ea8166d524SPL set ID 4c557ec4-c4cf-11df-851a-0800200c9a66RxCUI 1797847, 1797849UNII 0L591QR10I, O2GMZ0LF5W
Pharmacologic class: Corticosteroid; 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. Nasal products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400037024523 followed by a unit qualifier and the quantity

Package 00037-0245-23. 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 Dec 4, 2024.

Indications (excerpt from the label)

DYMISTA is indicated for the relief of symptoms of seasonal allergic rhinitis in adult and pediatric patients 6 years of age and older. DYMISTA contains an H 1 -receptor antagonist and a corticosteroid, and is indicated for the relief of symptoms of seasonal allergic rhinitis in adult and pediatric patients 6 years of age and older. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 202236

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

FDA NDC Directory listings under NDA 202236
Product	Strength	Form · route	Labeler	Product NDC
Azelastine Hydrochloride and Fluticasone Propionate	Azelastine hydrochloride 137 ug/1; Fluticasone propionate 50 ug/1	Spray, MeteredNasal	Mylan Pharmaceuticals Inc.	0378-3458