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NDC 70069-0091-01 Azelastine Hydrochloride 0.5 mg/mL Details
Azelastine Hydrochloride 0.5 mg/mL
Azelastine Hydrochloride is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Somerset Therapeutics, LLC. The primary component is AZELASTINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Ophthlamic azelastine is used to relieve the itching of allergic pink eye. Azelastine is in a class of medications called antihistamines. It works by blocking histamine, a substance in the body that causes allergic symptoms.
Related Packages: 70069-0091-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Azelastine Ophthalmic
Product Information
| NDC | 70069-0091 |
|---|---|
| Product ID | 70069-091_99a056e5-2dcd-4102-8132-55bf9b3ba069 |
| Associated GPIs | 86802006102020 |
| GCN Sequence Number | 040646 |
| GCN Sequence Number Description | azelastine HCl DROPS 0.05 % OPHTHALMIC |
| HIC3 | Q6R |
| HIC3 Description | EYE ANTIHISTAMINES |
| GCN | 94615 |
| 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 Hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION/ DROPS |
| Route | OPHTHALMIC |
| Active Ingredient Strength | 0.5 |
| Active Ingredient Units | mg/mL |
| Substance Name | AZELASTINE HYDROCHLORIDE |
| Labeler Name | Somerset Therapeutics, LLC |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA207411 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 70069-0091-01 (70069009101)
| NDC Package Code | 70069-091-01 |
|---|---|
| Billing NDC | 70069009101 |
| Package | 1 BOTTLE in 1 CARTON (70069-091-01) / 6 mL in 1 BOTTLE |
| Marketing Start Date | 2019-04-08 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 1.02542 |
| Pricing Unit | ML |
| Effective Date | 2024-02-21 |
| NDC Description | AZELASTINE HCL 0.05% DROPS |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
Cost) files, provide
state Medicaid agencies with covered outpatient drug prices by averaging
survey invoice
prices from retail community pharmacies across the United States. These
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