DYMISTA
- Product NDC
- 0037-0245
- 11-digit product format
- 000370245
- Labeler code
- 0037
- Product ID
- 0037-0245_ed1f7ce9-ccfa-4e73-940f-14ea8166d524
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azelastine Hydrochloride and Fluticasone Propionate
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- Viatris Specialty LLC
- Application
- NDA202236
- Marketing category
- NDA
- Marketing start
- 2016-10-01
- 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
- DYMISTA
- 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, 1797849 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0037-0245-23 | DYMISTA | 120 in 1 BOTTLE, SPRAY | SPRAY, METERED | 120 | | 21 |
| 0037-0245-23 | DYMISTA | 1 in 1 BOX | SPRAY, METERED | 1 | | 21 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AZELASTINE HYDROCHLORIDE | ACTIVE INGREDIENT | 0L591QR10I | DYMISTA (AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE) SPRAY, METERED [MEDA PHARMACEUTICALS INC.] | 9 | |
| FLUTICASONE PROPIONATE | ACTIVE INGREDIENT | O2GMZ0LF5W | DYMISTA (AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE) SPRAY, METERED [MEDA PHARMACEUTICALS INC.] | 9 | |
| AZELASTINE | ACTIVE MOIETY | ZQI909440X | DYMISTA (AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE) SPRAY, METERED [MEDA PHARMACEUTICALS INC.] | 9 | |
| FLUTICASONE | ACTIVE MOIETY | CUT2W21N7U | DYMISTA (AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE) SPRAY, METERED [MEDA PHARMACEUTICALS INC.] | 9 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | DYMISTA (AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE) SPRAY, METERED [MEDA PHARMACEUTICALS INC.] | 9 | |
| CARBOXYMETHYLCELLULOSE SODIUM | INACTIVE INGREDIENT | K679OBS311 | DYMISTA (AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE) SPRAY, METERED [MEDA PHARMACEUTICALS INC.] | 9 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DYMISTA (AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE) SPRAY, METERED [MEDA PHARMACEUTICALS INC.] | 9 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | DYMISTA (AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE) SPRAY, METERED [MEDA PHARMACEUTICALS INC.] | 9 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | DYMISTA (AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE) SPRAY, METERED [MEDA PHARMACEUTICALS INC.] | 9 | |
| PHENYLETHYL ALCOHOL | INACTIVE INGREDIENT | ML9LGA7468 | DYMISTA (AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE) SPRAY, METERED [MEDA PHARMACEUTICALS INC.] | 9 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | DYMISTA (AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE) SPRAY, METERED [MEDA PHARMACEUTICALS INC.] | 9 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | DYMISTA (AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE) SPRAY, METERED [MEDA PHARMACEUTICALS INC.] | 9 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0037-0245 | DYMISTA (AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE) SPRAY, METERED [MEDA PHARMACEUTICALS INC.] | 20 | Current NDC, Legacy NDC, 2 package rows | 20250210_4c557ec4-c4cf-11df-851a-0800200c9a66.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0037-0245-06 | 00037024506 | 1 BOTTLE, SPRAY in 1 BOX (0037-0245-06) > 28 SPRAY, METERED in 1 BOTTLE, SPRAY | 2012-05-01 | 0000-00-00 | No | No | Current |
| 0037-0245-23 | 00037024523 | 1 BOTTLE, SPRAY in 1 BOX (0037-0245-23) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY | 2016-10-01 | 0000-00-00 | No | No | Current |