Azelastine Hydrochloride NDC 71205-449

NDC codes

FDA NDC Directory

Product NDC (as listed)71205-449Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71205-0449Add 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
71205-449-30	71205044930	1 BOTTLE, SPRAY in 1 CARTON (71205-449-30) / 200 SPRAY, METERED in 1 BOTTLE, SPRAYMarketed from Apr 1, 2020

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 — 137 ug/1
Dosage form: Spray, Metered
Route: Nasal
Labeler: Proficient Rx LP
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077954
Marketing start: Mar 1, 2010
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 71205-449_91c72454-515f-4966-ad84-a78aba616fb5SPL ID 91c72454-515f-4966-ad84-a78aba616fb5SPL set ID 11a74cae-a15b-4a6b-a8c0-1e6a234ee258RxCUI 1797867UNII 0L591QR10IUPC 0371205449308
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

N471205044930 followed by a unit qualifier and the quantity

Package 71205-0449-30. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 077954

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

FDA NDC Directory listings under ANDA 077954
Product	Strength	Form · route	Labeler	Product NDC
Azelastine Hydrochloride	Azelastine hydrochloride 137 ug/1	Spray, MeteredNasal	Apotex Corp.	60505-0833
Azelastine Hydrochloride	Azelastine hydrochloride 137 ug/1	Spray, MeteredNasal	Preferred Pharmaceuticals Inc.	68788-4056
Azelastine Hydrochloride	Azelastine hydrochloride 137 ug/1	Spray, MeteredNasal	A-S Medication Solutions	50090-2330