FDA.reportPublic FDA data

NDC 0093-9019-19 - Cyclosporine Modified

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
0093-9019
Requested NDC
0093-9019-19
Package NDCs from labels
0093-9019-19, 0093-9019-65
Manufacturer
Teva Pharmaceuticals USA, Inc.
Effective date
2024-04-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
cycloSPORINE Capsules, USP MODIFIED (Soft Gelatin Capsules)Teva Pharmaceuticals USA, Inc.2024-04-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-9019-19CyclosporineModified1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED110
0093-9019-65CyclosporineModified30 in 1 CARTONCAPSULE, LIQUID FILLED3010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-9019CYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA, INC.]10Current NDC, Legacy NDC, 2 package rows20250227_2de1e8b1-625f-43ce-a1d5-d543be208b11.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-9019-19EA - Each0093-9019976228f8-3e10-44b2-ba3f-c0f9513423b612021-07-15
0093-9019-65EA - Each0093-9019653ff481-f185-47da-a820-1df63b3436eb12021-07-15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYCLOSPORINEACTIVE INGREDIENT83HN0GTJ6DCYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC]2
CYCLOSPORINEACTIVE MOIETY83HN0GTJ6DCYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC]2
.ALPHA.-TOCOPHEROL, DL-INACTIVE INGREDIENT7QWA1RIO01CYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MCYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC]2
BROWN IRON OXIDEINACTIVE INGREDIENT1N032N7MFOCYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC]2
GELATININACTIVE INGREDIENT2G86QN327LCYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC]2
GLYCINEINACTIVE INGREDIENTTE7660XO1CCYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC]2
POLYGLYCERYL-10 OLEATEINACTIVE INGREDIENT55C81W76DHCYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC]2
POLYGLYCERYL-3 OLEATEINACTIVE INGREDIENTXRQ165498BCYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC]2
POLYOXYL 40 HYDROGENATED CASTOR OILINACTIVE INGREDIENT7YC686GQ8FCYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC]2
SORBITOLINACTIVE INGREDIENT506T60A25RCYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOSPORINE MODIFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA INC]2

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 262 · 5,231 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Hand Sanitizer with Beaded Wristlet - EspressoALCOHOLShenzhen Lantern Scicence Co.,Ltd.59f160d3-7e42-ef07-e063-6394a90a6f8f2026-08-29WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer,4pk with Silicone Case,Cherry Blossom /Gardenia /Lavender Vanilla/ Coconut HoneyALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a2ab646-2dba-5111-e063-6394a90acc4f2026-08-29WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer,2pk with Woven Lanyard and Charms - Strawberry Dream/ Berry BlissALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a2b50a2-6ee2-04d4-e063-6294a90a1c652026-08-29WarningsExact identifier
unii: 3K9958V90M
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
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
rxcui: 835894
rxcui: 241834
rxcui: 835925
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
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.