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NDC 53002-1279-01 Azelastine Hydrochloride 137 ug/1 Details
Azelastine Hydrochloride 137 ug/1
Azelastine Hydrochloride is a NASAL SPRAY, METERED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by RPK Pharmaceuticals, Inc.. The primary component is AZELASTINE HYDROCHLORIDE.
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: 53002-1279-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Azelastine Nasal Spray
Product Information
| NDC | 53002-1279 |
|---|---|
| Product ID | 53002-1279_8c078b64-0a6e-45c0-9053-9172da11a7db |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Azelastine Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | azelastine hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SPRAY, METERED |
| Route | NASAL |
| Active Ingredient Strength | 137 |
| Active Ingredient Units | ug/1 |
| Substance Name | AZELASTINE HYDROCHLORIDE |
| Labeler Name | RPK Pharmaceuticals, Inc. |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA077954 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 53002-1279-01 (53002127901)
| NDC Package Code | 53002-1279-1 |
|---|---|
| Billing NDC | 53002127901 |
| Package | 1 BOTTLE, SPRAY in 1 CARTON (53002-1279-1) / 200 SPRAY, METERED in 1 BOTTLE, SPRAY |
| Marketing Start Date | 2020-01-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |