Prescription drug · NDA AUTHORIZED GENERIC
Azelastine Hydrochloride and Fluticasone Propionate NDC 0378-3458
Azelastine hydrochloride 137 ug/1; Fluticasone propionate 50 ug/1 · Spray, Metered · Nasal · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-3458-23 | 0037834582300378345823 | 1 BOTTLE in 1 BOX (0378-3458-23) / 120 SPRAY, METERED in 1 BOTTLEMarketed from Apr 14, 2020 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 and Fluticasone Propionate
- Generic name (nonproprietary)
- azelastine hydrochloride and fluticasone propionate
- Active ingredients
- Azelastine hydrochloride — 137 ug/1Fluticasone propionate — 50 ug/1
- Dosage form
- Spray, Metered
- Route
- Nasal
- Labeler
- Mylan Pharmaceuticals Inc.NDC labeler code 0378
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 202236
- Marketing start
- Marketing end
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0378-3458_6e1e173a-2d01-4e67-8361-dd30604bc8aaSPL ID 6e1e173a-2d01-4e67-8361-dd30604bc8aaSPL set ID 7b5cc5a0-0d47-46b5-b5fb-eb9cc248ae9eRxCUI 1797847UNII 0L591QR10I, O2GMZ0LF5W
- Pharmacologic class
- Corticosteroid; 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
N400378345823followed by a unit qualifier and the quantityPackage 00378-3458-23. 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 and fluticasone propionate nasal spray is indicated for the relief of symptoms of seasonal allergic rhinitis in adult and pediatric patients 6 years of age and older. Azelastine hydrochloride and fluticasone propionate nasal spray contains an H 1 -receptor antagonist and a corticosteroid, and is indicated for the relief of symptoms of seasonal allergic rhinitis in adult and pediatric patients 6 years of age and older. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0378-3458
- What is NDC 0378-3458?
- 0378-3458 is the product NDC for Azelastine Hydrochloride and Fluticasone Propionate, Azelastine hydrochloride 137 ug/1; Fluticasone propionate 50 ug/1 spray, metered, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Azelastine Hydrochloride and Fluticasone Propionate.
- What is the active ingredient?
- Azelastine hydrochloride, Fluticasone propionate.
- Who is the labeler?
- Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 Hydrochloride and Fluticasone Propionate?
- 5 other product NDCs are listed under this name. See all Azelastine Hydrochloride and Fluticasone Propionate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Azelastine Hydrochloride and Fluticasone Propionate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Azelastine Hydrochloride and Fluticasone Propionate | Azelastine hydrochloride 137 ug/1; Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Teva Pharmaceuticals, Inc. | 0480-2157 | 00480-2157-57 |
| Azelastine Hydrochloride And Fluticasone Propionateazelastine hydrochloride, fluticasone propionate | Azelastine hydrochloride 137 ug/1; Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Padagis Israel Pharmaceuticals Ltd | 45802-066 | 45802-0066-01 |
| Azelastine Hydrochloride And Fluticasone Propionateazelastine hydrochloride, fluticasone propionate | Azelastine hydrochloride 137 ug/1; Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Bryant Ranch Prepack | 63629-8612 | 63629-8612-01 |
| Azelastine Hydrochloride And Fluticasone Propionateazelastine hydrochloride, fluticasone propionate | Azelastine hydrochloride 137 ug/1; Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Bryant Ranch Prepack | 72162-1388 | 72162-1388-02 |
| Azelastine hydrochloride and Fluticasone propionate | Azelastine hydrochloride 137 ug/1; Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Apotex Corp. | 60505-0953 | 60505-0953-03 |
Other NDCs under NDA 202236
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 |
|---|---|---|---|---|
| Dymistaazelastine hydrochloride and fluticasone propionate | Azelastine hydrochloride 137 ug/1; Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | Viatris Specialty LLC | 0037-0245 |