Search by Drug Name or NDC
NDC 00023-9163-12 RESTASIS 0.5 mg/mL Details
RESTASIS 0.5 mg/mL
RESTASIS is a OPHTHALMIC EMULSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Allergan, Inc.. The primary component is CYCLOSPORINE.
MedlinePlus Drug Summary
Ophthalmic cyclosporine is used to increase tear production in people with dry eye disease. Cyclosporine is in a class of medications called immunomodulators. It works by decreasing swelling in the eye to allow for tear production.
Related Packages: 00023-9163-12Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Cyclosporine Ophthalmic
Product Information
| NDC | 00023-9163 |
|---|---|
| Product ID | 0023-9163_9821a057-4b01-42fd-84ba-3e30e41c2249 |
| Associated GPIs | 86720020001620 |
| GCN Sequence Number | 051820 |
| GCN Sequence Number Description | cyclosporine DROPERETTE 0.05 % OPHTHALMIC |
| HIC3 | Q2C |
| HIC3 Description | OPHTHALMIC ANTI-INFLAMMATORY IMMUNOMODULATOR-TYPE |
| GCN | 19216 |
| HICL Sequence Number | 004524 |
| HICL Sequence Number Description | CYCLOSPORINE |
| Brand/Generic | Brand |
| Proprietary Name | RESTASIS |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | cyclosporine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | EMULSION |
| Route | OPHTHALMIC |
| Active Ingredient Strength | 0.5 |
| Active Ingredient Units | mg/mL |
| Substance Name | CYCLOSPORINE |
| Labeler Name | Allergan, Inc. |
| Pharmaceutical Class | Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA050790 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00023-9163-12 (00023916312)
| NDC Package Code | 0023-9163-12 |
|---|---|
| Billing NDC | 00023916312 |
| Package | 5 VIAL, SINGLE-USE in 1 CARTON (0023-9163-12) / .4 mL in 1 VIAL, SINGLE-USE |
| Marketing Start Date | 2003-04-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |