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 3 of 262 · 5,231 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Touchland Power Mist Hand Sanitizer Citrus GroveALCOHOLChurch & Dwight Co., Inc.5a84344b-4ddb-32e5-e063-6394a90a628b2026-09-02WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer Frosted MintALCOHOLChurch & Dwight Co., Inc.5a8445e6-42cc-3e55-e063-6394a90ac0e12026-09-02WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer Lemon Lime SpritzALCOHOLChurch & Dwight Co., Inc.5a84870b-e539-9dd8-e063-6294a90aaf0b2026-09-02WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer Pure LavenderALCOHOLChurch & Dwight Co., Inc.5a848ff6-fbdd-a76c-e063-6294a90a324b2026-09-02WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer RainwaterALCOHOLChurch & Dwight Co., Inc.5a84969c-aa38-aeb7-e063-6294a90a69422026-09-02WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer UnscentedALCOHOLChurch & Dwight Co., Inc.5a84d2e3-d839-f7c6-e063-6294a90aa32f2026-09-02WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer Beach CocoALCOHOLChurch & Dwight Co., Inc.5a84db79-1bab-fff8-e063-6294a90aab372026-09-02WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer Velvet PeachALCOHOLChurch & Dwight Co., Inc.5a84ed55-f41d-d05f-e063-6394a90ad0122026-09-02WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer AppleliciousALCOHOLChurch & Dwight Co., Inc.5a84fbeb-dd64-26ce-e063-6294a90aa8562026-09-02WarningsExact identifier
unii: 3K9958V90M
Smart Care SQUISHMALLOWS Pretty Petal Scented HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.3884e292-1f03-4e08-90d9-82b601c0c5c22026-09-02WarningsExact identifier
unii: 3K9958V90M
Smart Care VANILLA FIG HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.c5490afe-b2b4-4c6c-910f-af828362d6a42026-09-02WarningsExact identifier
unii: 3K9958V90M
Smart Care MISTLETOE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.fca4510f-f130-464c-ade4-fe05bdae3e7b2026-09-01WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer,2pk -Gingerbread and Cherry CobblerALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a52731b-5e8c-5ae6-e063-6394a90a8b042026-08-31WarningsExact identifier
unii: 3K9958V90M
hydrating mist hand sanitizer with silicone keychain holder - beaver nuggetsALCOHOLGanzhou Olivee Cosmetic Co., Ltd.f875e065-7b3e-45dc-8a33-b893ab8306952026-08-31WarningsExact identifier
unii: 3K9958V90M
hydrating mist hand sanitizer with silicone keychain holder - signature scentALCOHOLGanzhou Olivee Cosmetic Co., Ltd.30e11bf0-1a21-45b1-adf9-cf3845419a982026-08-31WarningsExact identifier
unii: 3K9958V90M
Swisher Instant Hand Sanitizer GelALCOHOLEcolab Inc.1f84e842-ece4-4eb7-9ccf-d86cec78dbf22026-08-31WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer(Oval Shape)with Beaded Wristlet - Cherry BlossomALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a4fb4b6-ba9e-5b82-e063-6294a90a47342026-08-30WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer with Woven Lanyard and Chainendants- WatermelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a503581-061b-0050-e063-6294a90af48a2026-08-30WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer,2pk-Christmas Rose and Candy CaneALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a50402b-e4d7-3c0b-e063-6394a90a5e522026-08-30WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer,2pk -Bourbon Peacan and MistletoeALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a508fad-c7a4-82e8-e063-6294a90a0de12026-08-30WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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