Azelastine Hydrochloride NDC 58602-020

NDC codes

FDA NDC Directory

Product NDC (as listed)58602-020Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58602-0020Add 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
58602-020-07	58602002007	1 BOTTLE, SPRAY in 1 CARTON (58602-020-07) / 200 SPRAY, METERED in 1 BOTTLE, SPRAYMarketed from Jan 27, 2025
58602-020-51	58602002051	1 BOTTLE, SPRAY in 1 CARTON (58602-020-51) / 60 SPRAY, METERED in 1 BOTTLE, SPRAYMarketed from Jan 27, 2025
58602-020-52	58602002052	1 BOTTLE, SPRAY in 1 CARTON (58602-020-52) / 120 SPRAY, METERED in 1 BOTTLE, SPRAYMarketed from Jan 27, 2025

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): Azelastine Hydrochloride
Generic name (nonproprietary): azelastine hydrochloride
Active ingredients: Azelastine hydrochloride — 205.5 ug/1
Dosage form: Spray, Metered
Route: Nasal
Labeler: Aurohealth LLC
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216561
Marketing start: Jan 27, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 58602-020_78ffbb52-56db-49ea-9288-d0d4b263f373SPL ID 78ffbb52-56db-49ea-9288-d0d4b263f373SPL set ID 7281c597-651e-4425-8208-7637cd9d3500RxCUI 1797883UNII 0L591QR10I
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. Nasal products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N458602002007 followed by a unit qualifier and the quantity

Package 58602-0020-07. 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 Aug 20, 2026.

Indications (excerpt from the label)

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ■ nasal congestion ■ runny nose ■ sneezing ■ itchy nose

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 216561

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

FDA NDC Directory listings under ANDA 216561
Product	Strength	Form · route	Labeler	Product NDC
Azelastine Hydrochloride	Azelastine hydrochloride 205.5 ug/1	Spray, MeteredNasal	YYBA Corp	73581-500