Prescription drug · ANDA
Azelastine Hydrochloride NDC 47335-779
Azelastine hydrochloride 137 ug/1 · Spray, Metered · Nasal · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47335-779-91 | 47335077991 | 1 BOTTLE, SPRAY in 1 BOX (47335-779-91) / 200 SPRAY, METERED in 1 BOTTLE, SPRAYMarketed from May 24, 2012 |
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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090423
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 47335-779_09652cb1-7315-4188-9f36-4e2b50fb764dSPL ID 09652cb1-7315-4188-9f36-4e2b50fb764dSPL set ID 305c6dc8-8247-473d-9975-b02903af6d53RxCUI 1797867UNII 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
N447335077991followed by a unit qualifier and the quantityPackage 47335-0779-91. 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)
Azelastine hydrochloride nasal solution (nasal spray), 0.1% (137 mcg per spray) is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older. Azelastine hydrochloride nasal solution (nasal spray) is an H 1 -receptor antagonist indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older. ( 1 )
Excerpt only. Read the full label for complete information.