Azelastine Hydrochloride and Fluticasone Propionate
- Product NDC
- 0480-2157
- 11-digit product format
- 004802157
- Labeler code
- 0480
- Product ID
- 0480-2157_edea3e4b-7afc-4566-864d-acdf480a92af
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azelastine Hydrochloride and Fluticasone Propionate
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- Teva Pharmaceuticals, Inc.
- Application
- ANDA208436
- Marketing category
- ANDA
- Marketing start
- 2025-09-08
- Substance
- AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE
- Active strength
- 137; 50 ug/1; ug/1
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Azelastine Hydrochloride and Fluticasone Propionate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AZELASTINE HYDROCHLORIDE | 137 ug/1 |
| FLUTICASONE PROPIONATE | 50 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0L591QR10I, O2GMZ0LF5W |
| Rxcui | 1797847 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0480-2157-57 | Azelastine Hydrochloride and Fluticasone Propionate | 120 in 1 BOTTLE, SPRAY | SPRAY, METERED | 120 | | 2 |
| 0480-2157-57 | Azelastine Hydrochloride and Fluticasone Propionate | 1 in 1 CARTON | SPRAY, METERED | 1 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0480-2157-57 | 00480215757 | 1 BOTTLE, SPRAY in 1 CARTON (0480-2157-57) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY | 2025-09-08 | No | No | Current |