FDA.reportPublic FDA data

NDC 68084-879-95 - Cyclosporine

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68084-879
Requested NDC
68084-879-95
Package NDCs from labels
68084-879-95, 68084-879-25
Manufacturer
American Health Packaging
Effective date
2024-05-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cyclosporine - American Health PackagingAmerican Health Packaging2024-05-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-879-25Cyclosporine30 in 1 BOX, UNIT-DOSECAPSULE, GELATIN COATED308
68084-879-95Cyclosporine1 in 1 BLISTER PACKCAPSULE, GELATIN COATED18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-879CYCLOSPORINE CAPSULE, GELATIN COATED [AMERICAN HEALTH PACKAGING]8Current NDC, Legacy NDC, 2 package rows20240514_a8e29b54-e4ab-4bb9-ab6c-e4414a3f025b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-879-25EA - Each68084-8798abd5ee4-0e2a-41c7-9b4c-a74bbae1828c12015-12-02
68084-879-95EA - Each68084-8794817b6ed-76a5-49a9-b85f-41c02dbc98b912015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 257 · 5,125 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Hand Sanitizer,2pk with Woven Lanyard and Charms - Cherry and Honey VanillaALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a2c11e6-a105-5362-e063-6394a90a132f2026-08-29WarningsExact identifier
unii: 3K9958V90M
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Smart Care Hand Sanitizer with Glitter Silicone Case,2pk Vanilla Chai and EspressoALCOHOLShenzhen Lantern Scicence Co.,Ltd.59ef14d6-1a40-ea3c-e063-6394a90af4422026-08-28WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer with Glitter Silicone Case , 2pk Champagne Toast and Sparkling PomegranateALCOHOLShenzhen Lantern Scicence Co.,Ltd.597530cb-03f6-b72d-e063-6394a90a0d6c2026-08-28WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer,4pk with Silicone Case,Rosewater/Raspberry Fizz/Strawberry Vanilla/Pink PeonyALCOHOLShenzhen Lantern Scicence Co.,Ltd.59f1521c-ad5c-e2d6-e063-6394a90a4e2b2026-08-28WarningsExact identifier
unii: 3K9958V90M
Alcare Extra Hand SanitizerALCOHOLSC Johnson Professional USA Inc.5dc007a2-61fa-4115-a82c-1aa489a6bd392026-08-27WarningsExact identifier
unii: 3K9958V90M
Dehydrated AlcoholALCOHOLBreckenridge Pharmaceutical Incbe10b253-d72a-4f57-aa27-94c70ae8aed32026-08-27Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
CyclosporineCYCLOSPORINEStrides Pharma Science Limitedc36132b2-3ec7-4c43-a25e-75cbdbe3d88d2026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 83HN0GTJ6D
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
Surface x Cutie Pals Hand Sanitizer SurpriseALCOHOLI WORLD, LLC2e274b4a-953e-47ce-aa73-81576a4677102026-08-27WarningsExact identifier
unii: 3K9958V90M
Surface x Cutie Pals Hand Sanitizer Cherry PieALCOHOLI WORLD, LLC771fdce8-c633-4592-9bbf-5985c2536f2d2026-08-27WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer,2pk with Woven Lanyard and Charms - Sparkling Watermelon/ Pomegranate RaspberryALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a2a89f4-838e-e3ea-e063-6294a90a1ac22026-08-27WarningsExact identifier
unii: 3K9958V90M
Smart Care LAVENDER VANILLA HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.549c6774-a785-4a12-9ff9-9ba17befcc392026-08-27WarningsExact identifier
unii: 3K9958V90M
InstantFoam Complete PUREALCOHOLSC Johnson Professional USA Inc.398ca23c-7202-4670-be14-9829675f71742026-08-27WarningsExact identifier
unii: 3K9958V90M
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
Scentsational Square Hand SanitizerHAND SANITIZERRaining Rose, Inc.59f9bacf-80dc-3468-e063-6294a90a0ae12026-08-26WarningsExact identifier
unii: 3K9958V90M
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
SpectrumETHYL ALCOHOLMedline Industries, LP428b1cb9-7db8-3141-e054-00144ff8d46c2026-08-25WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.