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NDC 70069-0008-10 EPINASTINE HYDROCHLORIDE 0.5 mg/mL Details
EPINASTINE HYDROCHLORIDE 0.5 mg/mL
EPINASTINE 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 EPINASTINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Ophthalmic epinastine is used to prevent itching of the eyes caused by allergic conjunctivitis (a condition in which the eyes become itchy, swollen, red, and teary when they are exposed to certain substances in the air). Epinastine is in a class of medications called antihistamines. It works by preventing the release of natural substances which cause allergic reactions in the eyes.
Related Packages: 70069-0008-10Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Epinastine Ophthalmic
Product Information
| NDC | 70069-0008 |
|---|---|
| Product ID | 70069-008_bc4f6808-8013-4af0-b622-e8b809aa6371 |
| Associated GPIs | 86802028102020 |
| GCN Sequence Number | 053473 |
| GCN Sequence Number Description | epinastine HCl DROPS 0.05 % OPHTHALMIC |
| HIC3 | Q6R |
| HIC3 Description | EYE ANTIHISTAMINES |
| GCN | 20960 |
| HICL Sequence Number | 017021 |
| HICL Sequence Number Description | EPINASTINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | EPINASTINE HYDROCHLORIDE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | EPINASTINE HYDROCHLORIDE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION/ DROPS |
| Route | OPHTHALMIC |
| Active Ingredient Strength | 0.5 |
| Active Ingredient Units | mg/mL |
| Substance Name | EPINASTINE HYDROCHLORIDE |
| Labeler Name | Somerset Therapeutics, LLC |
| Pharmaceutical Class | Adrenergic Agonists [MoA], Adrenergic Receptor Agonist [EPC], Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA090951 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 70069-0008-10 (70069000810)
| NDC Package Code | 70069-008-10 |
|---|---|
| Billing NDC | 70069000810 |
| Package | 10 CARTON in 1 CARTON (70069-008-10) / 1 BOTTLE in 1 CARTON (70069-008-01) / 5 mL in 1 BOTTLE |
| Marketing Start Date | 2016-09-14 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |