Over-the-counter drug · ANDA
Azelastine HCl (Azelastine) NDC 69238-2147
Azelastine hydrochloride 205.5 ug/1 · Spray, Metered · Nasal · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-2147-3 | 6923821470369238214703 | 200 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
N469238214703followed by a unit qualifier and the quantityPackage 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.
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.