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NDC 42291-0094-30 Azelastine Hydrochloride 1 mg/mL Details
Azelastine Hydrochloride 1 mg/mL
Azelastine Hydrochloride is a NASAL SPRAY, METERED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AvKARE. 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: 42291-0094-30Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Azelastine Nasal Spray
Product Information
| NDC | 42291-0094 |
|---|---|
| Product ID | 42291-094_0e8b3b37-c0f4-3297-e063-6394a90ae2b0 |
| Associated GPIs | 42401015102020 |
| GCN Sequence Number | 029893 |
| GCN Sequence Number Description | azelastine HCl SPRAY/PUMP 137 MCG NASAL |
| HIC3 | Q7E |
| HIC3 Description | NASAL ANTIHISTAMINE |
| GCN | 60544 |
| HICL Sequence Number | 007607 |
| HICL Sequence Number Description | AZELASTINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Azelastine Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Azelastine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SPRAY, METERED |
| Route | NASAL |
| Active Ingredient Strength | 1 |
| Active Ingredient Units | mg/mL |
| Substance Name | AZELASTINE HYDROCHLORIDE |
| Labeler Name | AvKARE |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA204660 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 42291-0094-30 (42291009430)
| NDC Package Code | 42291-094-30 |
|---|---|
| Billing NDC | 42291009430 |
| Package | 1 BOTTLE, SPRAY in 1 CARTON (42291-094-30) / 30 mL in 1 BOTTLE, SPRAY |
| Marketing Start Date | 2021-03-03 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |