Prescription drug · ANDA
Azelastine NDC 67877-477
Azelastine hydrochloride 137 ug/1 · Spray, Metered · Nasal · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-477-50 | 67877047750 | 1 SPRAY, METERED in 1 BOTTLE (67877-477-50)Marketed from Aug 18, 2017 |
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
- Generic name (nonproprietary)
- azelastine
- Active ingredients
- Azelastine hydrochloride — 137 ug/1
- Dosage form
- Spray, Metered
- Route
- Nasal
- Labeler
- Ascend Laboratories, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208156
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 67877-477_b5281403-77e2-44a3-966f-d9c9efb86453SPL ID b5281403-77e2-44a3-966f-d9c9efb86453SPL set ID 77b20c6b-f30f-42a9-a0ef-d5d0bd3feb56RxCUI 1797867UNII 0L591QR10IUPC 0367877477503
- 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
N467877047750followed by a unit qualifier and the quantityPackage 67877-0477-50. 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 HCl Nasal 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 HCl 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.