Cyclosporine
- Product NDC
- 0378-8760
- 11-digit product format
- 003788760
- Labeler code
- 0378
- Product ID
- 0378-8760_da3fa070-b512-4568-871a-dc8d5a949d13
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cyclosporine
- Dosage form
- EMULSION
- Route
- OPHTHALMIC
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA205894
- Marketing category
- ANDA
- Marketing start
- 2022-02-03
- 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
- Cyclosporine
- 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 | 2572292 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-8760-58 | Cyclosporine | 6 in 1 CARTON | EMULSION | 6 | | 1 |
| 0378-8760-91 | Cyclosporine | 5 in 1 POUCH | EMULSION | 5 | | 1 |
| 0378-8760-91 | Cyclosporine | 12 in 1 CARTON | EMULSION | 12 | | 1 |
| 0378-8760-98 | Cyclosporine | 5 in 1 POUCH | EMULSION | 5 | | 1 |
| 0378-8760-98 | Cyclosporine | 0.4 mL in 1 VIAL, SINGLE-USE | EMULSION | 0.4 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-8760 | CYCLOSPORINE EMULSION [MYLAN PHARMACEUTICALS INC.] | 1 | Current NDC, Legacy NDC, 5 package rows | 20220205_da3fa070-b512-4568-871a-dc8d5a949d13.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 |
|---|
| 0378-8760-58 | 00378876058 | 6 POUCH in 1 CARTON (0378-8760-58) / 5 VIAL, SINGLE-USE in 1 POUCH (0378-8760-98) / .4 mL in 1 VIAL, SINGLE-USE | 6 pouch | 2022-02-03 | 0000-00-00 | No | No | Current |
| 0378-8760-91 | 00378876091 | 12 POUCH in 1 CARTON (0378-8760-91) / 5 VIAL, SINGLE-USE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-USE | 12 pouch | 2022-02-03 | 0000-00-00 | No | No | Current |
| 0378-8760-98 | 00378876098 | 5 in 1 POUCH | | | | | | Historical |