What is NDC 0280-0065?

0280-0065 is the product NDC for Astepro Allergy (azelastine hcl), Azelastine hydrochloride 205.5 ug/1 spray, metered, listed with the FDA by Bayer HealthCare LLC.. It has 7 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

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 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.

Astepro Allergy NDC 0280-0065 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0280-0065Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00280-0065Add 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
0280-0065-01	0028000650100280006501	60 CARTON in 1 BOTTLE (0280-0065-01) / 1 SPRAY, METERED in 1 CARTONMarketed from Jul 5, 2022 · Sample package
0280-0065-02	0028000650200280006502	120 CARTON in 1 BOTTLE (0280-0065-02) / 1 SPRAY, METERED in 1 CARTONMarketed from Jul 5, 2022
0280-0065-03	0028000650300280006503	120 PACKAGE in 1 BOTTLE (0280-0065-03) / 3 SPRAY, METERED in 1 PACKAGEMarketed from Jul 5, 2022
0280-0065-04	0028000650400280006504	200 CARTON in 1 BOTTLE (0280-0065-04) / 1 SPRAY, METERED in 1 CARTONMarketed from Jul 5, 2022
0280-0065-05	0028000650500280006505	22 CARTON in 1 BOTTLE (0280-0065-05) / 1 SPRAY, METERED in 1 CARTONMarketed from Jan 24, 2023 · Sample package
0280-0065-09	0028000650900280006509	120 CARTON in 1 BOTTLE (0280-0065-09) / 2 SPRAY, METERED in 1 CARTONMarketed from Jul 5, 2022
0280-0065-10	0028000651000280006510	22 CARTON in 1 BOTTLE (0280-0065-10) / 1 SPRAY, METERED in 1 CARTONMarketed from Jul 5, 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): 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 0280-0065_452641af-4731-7fc3-e063-6394a90abcebSPL ID 452641af-4731-7fc3-e063-6394a90abcebSPL set ID e0640846-19a6-7f79-e053-2995a90a8176RxCUI 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

N400280006501 followed by a unit qualifier and the quantity

Package 00280-0065-01. 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 0280-0065

What is NDC 0280-0065?: 0280-0065 is the product NDC for Astepro Allergy (azelastine hcl), Azelastine hydrochloride 205.5 ug/1 spray, metered, listed with the FDA by Bayer HealthCare LLC.. It has 7 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: 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 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
Children Astepro Allergyazelastine hcl	Azelastine hydrochloride 205.5 ug/1	Spray, MeteredNasal	Bayer HealthCare LLC.	0280-0066

Astepro Allergy (Azelastine hcl) NDC 0280-0065