What is NDC 0280-0066?

0280-0066 is the product NDC for Children Astepro Allergy (azelastine hcl), Azelastine hydrochloride 205.5 ug/1 spray, metered, listed with the FDA by Bayer HealthCare LLC.. It has 3 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Children Astepro Allergy (Azelastine HCl).

Bayer HealthCare LLC., NDC labeler code 0280. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Children Astepro Allergy?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Children Astepro Allergy NDC 0280-0066

NDC codes

FDA NDC Directory

Product NDC (as listed)0280-0066Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00280-0066Add 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
0280-0066-01	0028000660100280006601	60 CARTON in 1 BOTTLE (0280-0066-01) / 1 SPRAY, METERED in 1 CARTONMarketed from Jun 30, 2022 · Sample package
0280-0066-02	0028000660200280006602	120 CARTON in 1 BOTTLE (0280-0066-02) / 1 SPRAY, METERED in 1 CARTONMarketed from Jun 30, 2022
0280-0066-03	0028000660300280006603	22 CARTON in 1 BOTTLE (0280-0066-03) / 1 SPRAY, METERED in 1 CARTONMarketed from Jun 30, 2022

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): Children Astepro Allergy
Generic name (nonproprietary): azelastine hcl
Active ingredients: Azelastine hydrochloride — 205.5 ug/1
Dosage form: Spray, Metered
Route: Nasal
Labeler: Bayer HealthCare LLC.NDC labeler code 0280
Product type: Over-the-counter drug
Marketing category: NDA — New Drug ApplicationApplication NDA 213872
Marketing start: Jun 27, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 0280-0066_45263d0f-63fd-7187-e063-6394a90a06c0SPL ID 45263d0f-63fd-7187-e063-6394a90a06c0SPL set ID e26f9f67-4098-6d2e-e053-2995a90a8598RxCUI 1797883, 1797884UNII 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

N400280006601 followed by a unit qualifier and the quantity

Package 00280-0066-01. 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 Dec 4, 2025.

Indications (excerpt from the label)

Uses 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)

About NDC 0280-0066

What is NDC 0280-0066?: 0280-0066 is the product NDC for Children Astepro Allergy (azelastine hcl), Azelastine hydrochloride 205.5 ug/1 spray, metered, listed with the FDA by Bayer HealthCare LLC.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Children Astepro Allergy (Azelastine HCl).
What is the active ingredient?: Azelastine hydrochloride.
Who is the labeler?: Bayer HealthCare LLC., NDC labeler code 0280. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Children Astepro Allergy?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under NDA 213872

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

FDA NDC Directory listings under NDA 213872
Product	Strength	Form · route	Labeler	Product NDC
Astepro Allergyazelastine hcl	Azelastine hydrochloride 205.5 ug/1	Spray, MeteredNasal	Bayer HealthCare LLC.	0280-0065

Children Astepro Allergy (Azelastine hcl) NDC 0280-0066