Sandimmune
- Product NDC
- 0078-0109
- 11-digit product format
- 000780109
- Labeler code
- 0078
- Product ID
- 0078-0109_fa1f5eda-922e-49c8-a618-2967b00d1ac0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cyclosporine
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Novartis Pharmaceuticals Corporation
- Application
- NDA050573
- Marketing category
- NDA
- Marketing start
- 1983-11-14
- Substance
- CYCLOSPORINE
- Active strength
- 50 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sandimmune
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CYCLOSPORINE | 50 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 83HN0GTJ6D |
| Rxcui | 197552, 197553, 205175, 212810, 212844, 328160 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0078-0109-01 | Sandimmune | 10 in 1 BOX | INJECTION | 10 | | 36 |
| 0078-0109-61 | Sandimmune | 5 mL in 1 AMPULE | INJECTION | 5 | | 36 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CYCLOSPORINE | ACTIVE INGREDIENT | 83HN0GTJ6D | SANDIMMUNE (CYCLOSPORINE) CAPSULE, LIQUID FILLED SANDIMMUNE (CYCLOSPORINE) INJECTION SANDIMMUNE (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] | 17 | |
| CYCLOSPORINE | ACTIVE MOIETY | 83HN0GTJ6D | SANDIMMUNE (CYCLOSPORINE) CAPSULE, LIQUID FILLED SANDIMMUNE (CYCLOSPORINE) INJECTION SANDIMMUNE (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] | 17 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | SANDIMMUNE (CYCLOSPORINE) CAPSULE, LIQUID FILLED SANDIMMUNE (CYCLOSPORINE) INJECTION SANDIMMUNE (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] | 17 | |
| CASTOR OIL | INACTIVE INGREDIENT | D5340Y2I9G | SANDIMMUNE (CYCLOSPORINE) CAPSULE, LIQUID FILLED SANDIMMUNE (CYCLOSPORINE) INJECTION SANDIMMUNE (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] | 17 | |
| CORN OIL | INACTIVE INGREDIENT | 8470G57WFM | SANDIMMUNE (CYCLOSPORINE) CAPSULE, LIQUID FILLED SANDIMMUNE (CYCLOSPORINE) INJECTION SANDIMMUNE (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] | 17 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | SANDIMMUNE (CYCLOSPORINE) CAPSULE, LIQUID FILLED SANDIMMUNE (CYCLOSPORINE) INJECTION SANDIMMUNE (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] | 17 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | SANDIMMUNE (CYCLOSPORINE) CAPSULE, LIQUID FILLED SANDIMMUNE (CYCLOSPORINE) INJECTION SANDIMMUNE (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] | 17 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | SANDIMMUNE (CYCLOSPORINE) CAPSULE, LIQUID FILLED SANDIMMUNE (CYCLOSPORINE) INJECTION SANDIMMUNE (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] | 17 | |
| NITROGEN | INACTIVE INGREDIENT | N762921K75 | SANDIMMUNE (CYCLOSPORINE) CAPSULE, LIQUID FILLED SANDIMMUNE (CYCLOSPORINE) INJECTION SANDIMMUNE (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] | 17 | |
| OLIVE OIL | INACTIVE INGREDIENT | 6UYK2W1W1E | SANDIMMUNE (CYCLOSPORINE) CAPSULE, LIQUID FILLED SANDIMMUNE (CYCLOSPORINE) INJECTION SANDIMMUNE (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] | 17 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | SANDIMMUNE (CYCLOSPORINE) CAPSULE, LIQUID FILLED SANDIMMUNE (CYCLOSPORINE) INJECTION SANDIMMUNE (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] | 17 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SANDIMMUNE (CYCLOSPORINE) CAPSULE, LIQUID FILLED SANDIMMUNE (CYCLOSPORINE) INJECTION SANDIMMUNE (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] | 17 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0078-0109 | SANDIMMUNE (CYCLOSPORINE) CAPSULE, LIQUID FILLED SANDIMMUNE (CYCLOSPORINE) INJECTION SANDIMMUNE (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] | 32 | Current NDC, Legacy NDC, 2 package rows | 20250122_5e5926a7-1de0-4b54-a5c0-286b6200ff82.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 |
|---|
| 0078-0109-01 | 00078010901 | 10 AMPULE in 1 BOX (0078-0109-01) / 5 mL in 1 AMPULE (0078-0109-61) | 10 ampule | 1983-11-14 | 0000-00-00 | No | No | Current |
| 0078-0109-61 | 00078010961 | 5 mL in 1 AMPULE | 5 ml | | | | | Historical |