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 7 of 262 · 5,231 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WISH HAND SANITIZER Banana Cream SugarALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA5912d7e8-94a7-e8b9-e063-6394a90a74d62026-08-15WarningsExact identifier
unii: 3K9958V90M
WISH HAND SANITIZER Caramel Vanilla PopcornALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA591317be-856e-1374-e063-6394a90a7aaf2026-08-15WarningsExact identifier
unii: 3K9958V90M
WISH HAND SANITIZER Strawberry MuskALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA59143edb-41fe-0a1f-e063-6394a90a81a52026-08-15WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST ICED SUGAR COOKIE SCENTETHYL ALCOHOLAmber Glow Cosmetics Limitedb83a5eef-e2ae-4044-9dce-fd69a5ec5e812026-08-14WarningsExact identifier
unii: 3K9958V90M
WISH HAND SANITIZER Rose WoodsALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA58fb4491-2918-c486-e063-6394a90a621f2026-08-14WarningsExact identifier
unii: 3K9958V90M
Alcohol Sanitizer Spray.ETHYL ALCOHOLGuangdong Yanze Biotechnology Co., Ltd.58fb9efe-43f0-1b7f-e063-6394a90a01452026-08-14WarningsExact identifier
unii: 3K9958V90M
BM BM164 DROPSARUM TRYPH, CAUSTICUM, BALSAMUM PERU, HELONIAS DIO, ACID PHOS, GLYCERINUM, EQUISETUMBM Private Limited5902770f-eb01-d099-e063-6394a90ad3eb2026-08-14WarningsExact identifier
unii: PDC6A3C0OX
FRESH FEELS HAND SANITIZER MIST CHILL COCONUT SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited6da508ab-176c-4cca-aa1b-c161d9160cd12026-08-14WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST ICED CHERRY SCENTETHYL ALCOHOLAmber Glow Cosmetics Limitedeba7108c-7d96-4393-9444-b3ce2ec7a0602026-08-13WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST BERRY SPRINKLE SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited08deb4c2-4ba4-4ec0-b2d2-5cc7f851df4b2026-08-13WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST BERRY SPRINKLE SWIRL SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited424454c9-c1d3-46ec-b186-9159c29f7a4a2026-08-13WarningsExact identifier
unii: 3K9958V90M
Zep Alcohol SanitizerETHANOLZep Inc.b932a59c-a739-5441-e053-2a95a90a4cfa2026-08-13WarningsExact identifier
unii: 3K9958V90M
Zep Fuzion Instant Hand SanitizerALCOHOLZep Inc.b43c5701-22ee-1de4-e053-2995a90a8f642026-08-13WarningsExact identifier
unii: 3K9958V90M
Zep Instant Hand Sanitizer GelALCOHOLZep Inc.b0ee8023-0128-56d6-e053-2a95a90ab4ed2026-08-13WarningsExact identifier
unii: 3K9958V90M
Zep Instant Hand Sanitizer GelALCOHOLZep Inc.b0ed98cd-871b-d862-e053-2995a90a14cc2026-08-13WarningsExact identifier
unii: 3K9958V90M
AFCO 5511 Sanifect E3ETHANOLZep Inc.34795eba-9ec4-6401-e063-6394a90af4282026-08-13WarningsExact identifier
unii: 3K9958V90M
Alcohol Hand SanitizerETHYL ALCOHOLGuangdong Yanze Biotechnology Co., Ltd.58fa90dc-c3b5-787b-e063-6294a90a2e172026-08-13WarningsExact identifier
unii: 3K9958V90M
WISH HAND SANITIZER Mango Coconut CreamALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA58faa781-520b-92fa-e063-6294a90a9ecf2026-08-13WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST COCONUT VANILLA SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited89dd227a-365f-4d8b-b21a-4f1c1b5c9c0a2026-08-13WarningsExact identifier
unii: 3K9958V90M
SprinJeneALCOHOLHealth and Natural Beauty USA Corp1853f023-f4db-4cd8-a4df-a439bc306cc32026-08-13WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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