FDA.reportPublic FDA data

Cyclosporine

Product NDC
60505-0134
11-digit product format
605050134
Labeler code
60505
Product ID
60505-0134_561ed7a8-f342-f4fe-ce36-998d87c33e7f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclosporine
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA065040
Marketing category
ANDA
Marketing start
2002-05-29
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

Additional Listing Data#

Finished product
Yes
Brand name base
Cyclosporine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOSPORINE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii83HN0GTJ6D
Rxcui197553, 328160

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1be408a0-e15a-4092-b35e-4e294e65196fProduct name320240216
b3fdee3e-0c46-442f-aad5-aa71941d5621Product name120231023
78fb0708-fce5-decd-6611-5a9fbe3e3decProduct name320230327
54840517-000d-4fcb-b976-a6ddd102faa0Product name120220120
a5ba3bd0-8411-4005-ac3b-a41d8ee0633aProduct name120181029
b1c0d609-8b97-06ee-2cd0-5652a4b1d019Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-0134-0Cyclosporine30 in 1 BOTTLECAPSULE, GELATIN COATED3015
60505-0134-1Cyclosporine1000 in 1 BOTTLECAPSULE, GELATIN COATED100015
60505-0134-2Cyclosporine500 in 1 BOTTLECAPSULE, GELATIN COATED50015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0134-0EA - Each60505-01344ecb67b7-b6c7-4f13-941d-7562d407794612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYCLOSPORINEACTIVE INGREDIENT83HN0GTJ6DCYCLOSPORINE CAPSULE, GELATIN COATED [APOTEX CORP.]7
CYCLOSPORINEACTIVE MOIETY83HN0GTJ6DCYCLOSPORINE CAPSULE, GELATIN COATED [APOTEX CORP.]7
ALCOHOLINACTIVE INGREDIENT3K9958V90MCYCLOSPORINE CAPSULE, GELATIN COATED [APOTEX CORP.]7
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3CYCLOSPORINE CAPSULE, GELATIN COATED [APOTEX CORP.]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCYCLOSPORINE CAPSULE, GELATIN COATED [APOTEX CORP.]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCYCLOSPORINE CAPSULE, GELATIN COATED [APOTEX CORP.]7
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCYCLOSPORINE CAPSULE, GELATIN COATED [APOTEX CORP.]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACYCLOSPORINE CAPSULE, GELATIN COATED [APOTEX CORP.]7
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CYCLOSPORINE CAPSULE, GELATIN COATED [APOTEX CORP.]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CYCLOSPORINE CAPSULE, GELATIN COATED [APOTEX CORP.]7
GELATININACTIVE INGREDIENT2G86QN327LCYCLOSPORINE CAPSULE, GELATIN COATED [APOTEX CORP.]7
METHYL ALCOHOLINACTIVE INGREDIENTY4S76JWI15CYCLOSPORINE CAPSULE, GELATIN COATED [APOTEX CORP.]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CYCLOSPORINE CAPSULE, GELATIN COATED [APOTEX CORP.]7
SHELLACINACTIVE INGREDIENT46N107B71OCYCLOSPORINE CAPSULE, GELATIN COATED [APOTEX CORP.]7
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCYCLOSPORINE CAPSULE, GELATIN COATED [APOTEX CORP.]7
TALCINACTIVE INGREDIENT7SEV7J4R1UCYCLOSPORINE CAPSULE, GELATIN COATED [APOTEX CORP.]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOSPORINE CAPSULE, GELATIN COATED [APOTEX CORP.]7
WATERINACTIVE INGREDIENT059QF0KO0RCYCLOSPORINE CAPSULE, GELATIN COATED [APOTEX CORP.]7
CYCLOSPORINEACTIVE INGREDIENT83HN0GTJ6DCYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING]3
CYCLOSPORINEACTIVE MOIETY83HN0GTJ6DCYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MCYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING]3
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3CYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING]3
GELATININACTIVE INGREDIENT2G86QN327LCYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING]3
METHYL ALCOHOLINACTIVE INGREDIENTY4S76JWI15CYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING]3
SHELLACINACTIVE INGREDIENT46N107B71OCYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING]3
TALCINACTIVE INGREDIENT7SEV7J4R1UCYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING]3
WATERINACTIVE INGREDIENT059QF0KO0RCYCLOSPORINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING]3
CYCLOSPORINEACTIVE INGREDIENT83HN0GTJ6DCYCLOSPORINE CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]2
CYCLOSPORINEACTIVE MOIETY83HN0GTJ6DCYCLOSPORINE CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0134CYCLOSPORINE CAPSULE, GELATIN COATED [APOTEX CORP.]14Current NDC, Legacy NDC, 3 package rows20250413_bfca7088-fe93-abb9-3ec3-e6f5710a69c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
328160cycloSPORINE 100 MG Oral CapsulePSNbfca7088-fe93-abb9-3ec3-e6f5710a69c615
197553cycloSPORINE 25 MG Oral CapsulePSNbfca7088-fe93-abb9-3ec3-e6f5710a69c615
328160cyclosporine 100 MG Oral CapsuleSCDbfca7088-fe93-abb9-3ec3-e6f5710a69c615
197553cyclosporine 25 MG Oral CapsuleSCDbfca7088-fe93-abb9-3ec3-e6f5710a69c615
328160cycloSPORINE 100 MG Oral CapsulePSNa8e29b54-e4ab-4bb9-ab6c-e4414a3f025b8
197553cycloSPORINE 25 MG Oral CapsulePSNa8e29b54-e4ab-4bb9-ab6c-e4414a3f025b8
328160cyclosporine 100 MG Oral CapsuleSCDa8e29b54-e4ab-4bb9-ab6c-e4414a3f025b8
197553cyclosporine 25 MG Oral CapsuleSCDa8e29b54-e4ab-4bb9-ab6c-e4414a3f025b8
328160cycloSPORINE 100 MG Oral CapsulePSN7014e788-a08a-46a2-a04a-2dd68f7201aa2
328160cyclosporine 100 MG Oral CapsuleSCD7014e788-a08a-46a2-a04a-2dd68f7201aa2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-0134-06050501340030 CAPSULE, GELATIN COATED in 1 BOTTLE (60505-0134-0) 2002-05-292025-02-28NoNoCurrent
60505-0134-1605050134011000 CAPSULE, GELATIN COATED in 1 BOTTLE (60505-0134-1) 2002-05-292025-02-28NoNoCurrent
60505-0134-260505013402500 CAPSULE, GELATIN COATED in 1 BOTTLE (60505-0134-2) 2002-05-292025-02-28NoNoCurrent