Restasis MultiDose
- Product NDC
- 0023-5301
- 11-digit product format
- 000235301
- Labeler code
- 0023
- Product ID
- 0023-5301_6b6704de-6a92-4d21-8cb5-fbd1c2f3c489
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cyclosporine
- Dosage form
- EMULSION
- Route
- OPHTHALMIC
- Labeler
- Allergan, Inc.
- Application
- NDA050790
- Marketing category
- NDA
- Marketing start
- 2016-11-10
- Substance
- CYCLOSPORINE
- Active strength
- .5 mg/mL
- Pharmacologic classes
- Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Restasis MultiDose
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CYCLOSPORINE | .5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 83HN0GTJ6D |
| Rxcui | 351291, 402092 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0023-5301-05 | Restasis MultiDose | 5.5 mL in 1 BOTTLE | EMULSION | 5.5 | | 15 |
| 0023-5301-05 | Restasis MultiDose | 1 in 1 CARTON | EMULSION | 1 | | 15 |
| 0023-5301-08 | Restasis MultiDose | 5.5 mL in 1 BOTTLE | EMULSION | 5.5 | | 15 |
| 0023-5301-08 | Restasis MultiDose | 1 in 1 CARTON | EMULSION | 1 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0023-5301 | RESTASIS MULTIDOSE (CYCLOSPORINE) EMULSION [ALLERGAN, INC.] | 14 | Current NDC, Legacy NDC, 4 package rows | 20250410_7224d810-bb96-4682-a942-3355e6e8061a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0023-5301-01 | 00023530101 | 1 BOTTLE in 1 CARTON (0023-5301-01) > 1.5 mL in 1 BOTTLE | 1 bottle | 2016-11-10 | 0000-00-00 | No | No | Current |
| 0023-5301-05 | 00023530105 | 1 BOTTLE in 1 CARTON (0023-5301-05) / 5.5 mL in 1 BOTTLE | 1 bottle | 2016-11-10 | 0000-00-00 | No | No | Current |
| 0023-5301-08 | 00023530108 | 1 BOTTLE in 1 CARTON (0023-5301-08) > 5.5 mL in 1 BOTTLE | 1 bottle | 2016-11-10 | 0000-00-00 | Yes | No | Current |