NDC codes

FDA NDC Directory
Product NDC (as listed)69238-2147Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69238-2147Add 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 NDC11-digit (billing)PackageCopy
69238-2147-36923821470369238214703200 CARTON in 1 BOTTLE (69238-2147-3) / 1 SPRAY, METERED in 1 CARTONMarketed from Jun 7, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 HCl
Generic name (nonproprietary)
azelastine
Active ingredients
Azelastine hydrochloride — 205.5 ug/1
Dosage form
Spray, Metered
Route
Nasal
Labeler
Amneal Pharmaceuticals NY LLCNDC labeler code 69238
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 216576
Marketing start
Listing expires
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 69238-2147_125e35a1-2e6f-4646-aad2-d6465917671cSPL ID 125e35a1-2e6f-4646-aad2-d6465917671cSPL set ID 82610437-25f4-4ae0-9d6a-381e9932f87dRxCUI 1797883UNII 0L591QR10IUPC 0365162706840
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

N469238214703 followed by a unit qualifier and the quantity

Package 69238-2147-03. 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 .

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)

About NDC 69238-2147

What is NDC 69238-2147?
69238-2147 is the product NDC for Azelastine HCl (azelastine), Azelastine hydrochloride 205.5 ug/1 spray, metered, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Azelastine HCl (Azelastine).
What is the active ingredient?
Azelastine hydrochloride.
Who is the labeler?
Amneal Pharmaceuticals NY LLC, NDC labeler code 69238. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Azelastine HCl?
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.

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