Cyclosporine
- Product NDC
- 0093-9019
- 11-digit product format
- 000939019
- Labeler code
- 0093
- Product ID
- 0093-9019_d5d977b4-fc80-4e46-ab55-280fd6d4ea12
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclosporine
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA065110
- Marketing category
- ANDA
- Marketing start
- 2021-06-08
- Substance
- CYCLOSPORINE
- Active strength
- 50 mg/1
- 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
- Brand name suffix
- Modified
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CYCLOSPORINE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 83HN0GTJ6D |
| Rxcui | 241834, 835894, 835925 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0093-9019-19 | CyclosporineModified | 1 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 1 | | 10 |
| 0093-9019-65 | CyclosporineModified | 30 in 1 CARTON | CAPSULE, LIQUID FILLED | 30 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CYCLOSPORINE | ACTIVE INGREDIENT | 83HN0GTJ6D | CYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC] | 2 | |
| CYCLOSPORINE | ACTIVE MOIETY | 83HN0GTJ6D | CYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC] | 2 | |
| .ALPHA.-TOCOPHEROL, DL- | INACTIVE INGREDIENT | 7QWA1RIO01 | CYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC] | 2 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | CYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC] | 2 | |
| BROWN IRON OXIDE | INACTIVE INGREDIENT | 1N032N7MFO | CYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC] | 2 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | CYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC] | 2 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | CYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC] | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | CYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC] | 2 | |
| GLYCINE | INACTIVE INGREDIENT | TE7660XO1C | CYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC] | 2 | |
| POLYGLYCERYL-10 OLEATE | INACTIVE INGREDIENT | 55C81W76DH | CYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC] | 2 | |
| POLYGLYCERYL-3 OLEATE | INACTIVE INGREDIENT | XRQ165498B | CYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC] | 2 | |
| POLYOXYL 40 HYDROGENATED CASTOR OIL | INACTIVE INGREDIENT | 7YC686GQ8F | CYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC] | 2 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | CYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0093-9019 | CYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA, INC.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20250227_2de1e8b1-625f-43ce-a1d5-d543be208b11.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 |
|---|
| 0093-9019-19 | 00093901919 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 0093-9019-65 | 00093901965 | 30 BLISTER PACK in 1 CARTON (0093-9019-65) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0093-9019-19) | 30 blister pack | 2021-06-08 | 0000-00-00 | No | No | Current |