Cyclosporine
- Product NDC
- 68084-879
- 11-digit product format
- 680840879
- Labeler code
- 68084
- Product ID
- 68084-879_1857b1ea-c3f7-696a-e063-6394a90ad6eb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclosporine
- Dosage form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA065040
- Marketing category
- ANDA
- Marketing start
- 2015-09-30
- Substance
- CYCLOSPORINE
- Active strength
- 25 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CYCLOSPORINE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 83HN0GTJ6D |
| Rxcui | 197553, 328160 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68084-879-25 | Cyclosporine | 30 in 1 BOX, UNIT-DOSE | CAPSULE, GELATIN COATED | 30 | | 8 |
| 68084-879-95 | Cyclosporine | 1 in 1 BLISTER PACK | CAPSULE, GELATIN COATED | 1 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CYCLOSPORINE | ACTIVE INGREDIENT | 83HN0GTJ6D | CYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] | 3 | |
| CYCLOSPORINE | ACTIVE MOIETY | 83HN0GTJ6D | CYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] | 3 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | CYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] | 3 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | CYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] | 3 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | CYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] | 3 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | CYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] | 3 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | CYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] | 3 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | CYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] | 3 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | CYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] | 3 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | CYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] | 3 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | CYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] | 3 | |
| METHYL ALCOHOL | INACTIVE INGREDIENT | Y4S76JWI15 | CYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] | 3 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | CYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] | 3 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | CYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] | 3 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | CYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | CYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | CYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68084-879 | CYCLOSPORINE CAPSULE, GELATIN COATED [AMERICAN HEALTH PACKAGING] | 8 | Current NDC, Legacy NDC, 2 package rows | 20240514_a8e29b54-e4ab-4bb9-ab6c-e4414a3f025b.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 |
|---|
| 68084-879-25 | 68084087925 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-879-25) / 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK (68084-879-95) | 30 blister pack | 2015-09-30 | 0000-00-00 | No | No | Current |
| 68084-879-95 | 68084087995 | 1 in 1 BLISTER PACK | | | | | | Historical |