Cyclosporine
- Product NDC
- 59651-929
- 11-digit product format
- 596510929
- Labeler code
- 59651
- Product ID
- 59651-929_aaf79e72-26bf-4152-9cd1-10d8c30fa4fe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclosporine
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA219652
- Marketing category
- ANDA
- Marketing start
- 2026-09-17
- Substance
- CYCLOSPORINE
- Active strength
- 100 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
- 2027-12-31
- Current FDA listing
- Yes
Source provenance: Browse the complete Orange Book source catalog.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cyclosporine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CYCLOSPORINE | 100 mg/1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 59651-929-65 | 59651092965 | 5 BLISTER PACK in 1 CARTON (59651-929-65) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 5 blister pack | 2026-09-17 | No | No | Current |