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NDC 00023-5301-08 Restasis MultiDose 0.5 mg/mL Details
Restasis MultiDose 0.5 mg/mL
Restasis MultiDose is a OPHTHALMIC EMULSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Allergan, Inc.. The primary component is CYCLOSPORINE.
Product Information
NDC | 00023-5301 |
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Product ID | 0023-5301_884a1d8c-14e0-464c-a6b6-bfdd7009d514 |
Associated GPIs | 86720020001620 |
GCN Sequence Number | 076793 |
GCN Sequence Number Description | cyclosporine DROPS 0.05 % OPHTHALMIC |
HIC3 | Q2C |
HIC3 Description | OPHTHALMIC ANTI-INFLAMMATORY IMMUNOMODULATOR-TYPE |
GCN | 42588 |
HICL Sequence Number | 004524 |
HICL Sequence Number Description | CYCLOSPORINE |
Brand/Generic | Brand |
Proprietary Name | Restasis MultiDose |
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 00023-5301-08 (00023530108)
NDC Package Code | 0023-5301-08 |
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Billing NDC | 00023530108 |
Package | 1 BOTTLE in 1 CARTON (0023-5301-08) / 5.5 mL in 1 BOTTLE |
Marketing Start Date | 2016-11-10 |
NDC Exclude Flag | N |
Pricing Information | N/A |