AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE
- Product NDC
- 45802-066
- 11-digit product format
- 458020066
- Labeler code
- 45802
- Product ID
- 45802-066_26745ea7-7084-4000-9571-5795c176cc6f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- azelastine hydrochloride, fluticasone propionate
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- Padagis Israel Pharmaceuticals Ltd
- Application
- ANDA208111
- Marketing category
- ANDA
- Marketing start
- 2021-03-01
- 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 |
|---|
| 45802-066-01 | AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE | 1 in 1 CARTON | SPRAY, METERED | 1 | | 7 |
| 45802-066-01 | AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE | 120 in 1 BOTTLE | SPRAY, METERED | 120 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45802-066 | AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE (AZELASTINE HYDROCHLORIDE, FLUTICASONE PROPIONATE) SPRAY, METERED [PADAGIS ISRAEL PHARMACEUTICALS LTD] | 7 | Current NDC, Legacy NDC, 2 package rows | 20250215_625ffdd0-8486-49af-8e77-6aa663be5ac7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 45802-066-01 | 45802006601 | 1 BOTTLE in 1 CARTON (45802-066-01) / 120 SPRAY, METERED in 1 BOTTLE | 1 bottle | 2021-03-01 | 0000-00-00 | No | No | Current |