Prescription drug · ANDA
Azelastine Hydrochloride NDC 60505-0833
Azelastine hydrochloride 137 ug/1 · Spray, Metered · Nasal · Apotex Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-0833-5 | 60505083305 | 1 BOTTLE, SPRAY in 1 CARTON (60505-0833-5) / 200 SPRAY, METERED in 1 BOTTLE, SPRAYMarketed from Mar 1, 2010 |
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 Hydrochloride
- Generic name (nonproprietary)
- azelastine hydrochloride
- Active ingredients
- Azelastine hydrochloride — 137 ug/1
- Dosage form
- Spray, Metered
- Route
- Nasal
- Labeler
- Apotex Corp.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077954
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 60505-0833_1609cf10-ae35-1f3e-0d03-3d7caa05a1adSPL ID 1609cf10-ae35-1f3e-0d03-3d7caa05a1adSPL set ID 4f58c203-f649-a18e-aaf3-70b0797652f4RxCUI 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
N460505083305followed by a unit qualifier and the quantityPackage 60505-0833-05. 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 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 spray is an H1-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.
Other NDCs under ANDA 077954
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Azelastine Hydrochloride | Azelastine hydrochloride 137 ug/1 | Spray, MeteredNasal | Preferred Pharmaceuticals Inc. | 68788-4056 |
| Azelastine Hydrochloride | Azelastine hydrochloride 137 ug/1 | Spray, MeteredNasal | Proficient Rx LP | 71205-449 |
| Azelastine Hydrochloride | Azelastine hydrochloride 137 ug/1 | Spray, MeteredNasal | A-S Medication Solutions | 50090-2330 |