Search by Drug Name or NDC
NDC 00378-3458-23 Azelastine Hydrochloride and Fluticasone Propionate 137; 50 ug/1; ug/1 Details
Azelastine Hydrochloride and Fluticasone Propionate 137; 50 ug/1; ug/1
Azelastine Hydrochloride and Fluticasone Propionate is a NASAL SPRAY, METERED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE.
MedlinePlus Drug Summary
Azelastine, an antihistamine, is used to treat hay fever and allergy symptoms including runny nose, sneezing, and itchy nose. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Related Packages: 00378-3458-23Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Azelastine Nasal Spray
Nonprescription fluticasone nasal spray (Flonase Allergy) is used to relieve symptoms of rhinitis such as sneezing and a runny, stuffy, or itchy nose and itchy, watery eyes caused by hay fever or other allergies (caused by an allergy to pollen, mold, dust, or pets). Prescription fluticasone is also used to relieve symptoms of nonallergic rhinitis such as sneezing and runny or stuffy nose which are not caused by allergies. Prescription fluticasone nasal spray (Xhance) is used to treat nasal polyps (swelling of the lining of the nose). Fluticasone nasal spray should not be used to treat symptoms (e.g., sneezing, stuffy, runny, itchy nose) caused by the common cold. Fluticasone is in a class of medications called corticosteroids. It works by blocking the release of certain natural substances that cause allergy symptoms.
Related Packages: 00378-3458-23Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fluticasone Nasal Spray
Product Information
| NDC | 00378-3458 |
|---|---|
| Product ID | 0378-3458_01e2dbc0-78d5-46da-afad-9610e42ed3ee |
| Associated GPIs | 42995502151820 |
| GCN Sequence Number | 069144 |
| GCN Sequence Number Description | azelastine/fluticasone SPRAY/PUMP 137-50 MCG NASAL |
| HIC3 | Q7O |
| HIC3 Description | NASAL ANTIHISTAMINE AND ANTI-INFLAM. STEROID COMB. |
| GCN | 32099 |
| HICL Sequence Number | 038953 |
| HICL Sequence Number Description | AZELASTINE HCL/FLUTICASONE PROPIONATE |
| Brand/Generic | Generic |
| Proprietary Name | Azelastine Hydrochloride and Fluticasone Propionate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Azelastine Hydrochloride and Fluticasone Propionate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SPRAY, METERED |
| Route | NASAL |
| Active Ingredient Strength | 137; 50 |
| Active Ingredient Units | ug/1; ug/1 |
| Substance Name | AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Pharmaceutical Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA AUTHORIZED GENERIC |
| Application Number | NDA202236 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00378-3458-23 (00378345823)
| NDC Package Code | 0378-3458-23 |
|---|---|
| Billing NDC | 00378345823 |
| Package | 1 BOTTLE in 1 BOX (0378-3458-23) / 120 SPRAY, METERED in 1 BOTTLE |
| Marketing Start Date | 2020-04-14 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 3.4127 |
| Pricing Unit | GM |
| Effective Date | 2024-02-21 |
| NDC Description | AZELASTIN-FLUTIC 137-50 MCG SPR |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1, 5, 6 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |