FDA.reportPublic FDA data

NDC 58198-9725 - Atopica for Cats

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
58198-9725
Package NDCs from labels
58198-9725-1, 58198-9725-2
Manufacturer
Elanco US Inc.
Effective date
2026-07-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Atopica™ for Cats (cyclosporine oral solution) USP MODIFIED 100 mg/mLElanco US Inc.2026-07-22PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58198-9725-1Atopica for Cats5 mL in 1 BOTTLE, GLASSSOLUTION511
58198-9725-1Atopica for Cats1 in 1 CARTONSOLUTION111
58198-9725-2Atopica for Cats1 in 1 CARTONSOLUTION111
58198-9725-2Atopica for Cats17 mL in 1 BOTTLE, GLASSSOLUTION1711

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58198-9725ATOPICA FOR CATS (CYCLOSPORINE) SOLUTION [ELANCO US INC.]104 package rows20211214_47f70173-a1d9-4156-9a7f-0f296e5dd64b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYCLOSPORINEACTIVE INGREDIENT83HN0GTJ6DATOPICA FOR CATS (CYCLOSPORINE) SOLUTION [NOVARTIS ANIMAL HEALTH US, INC.]6
CYCLOSPORINEACTIVE MOIETY83HN0GTJ6DATOPICA FOR CATS (CYCLOSPORINE) SOLUTION [NOVARTIS ANIMAL HEALTH US, INC.]6
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1ATOPICA FOR CATS (CYCLOSPORINE) SOLUTION [NOVARTIS ANIMAL HEALTH US, INC.]6
ALCOHOLINACTIVE INGREDIENT3K9958V90MATOPICA FOR CATS (CYCLOSPORINE) SOLUTION [NOVARTIS ANIMAL HEALTH US, INC.]6
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GATOPICA FOR CATS (CYCLOSPORINE) SOLUTION [NOVARTIS ANIMAL HEALTH US, INC.]6
CORN OILINACTIVE INGREDIENT8470G57WFMATOPICA FOR CATS (CYCLOSPORINE) SOLUTION [NOVARTIS ANIMAL HEALTH US, INC.]6
NITROGENINACTIVE INGREDIENTN762921K75ATOPICA FOR CATS (CYCLOSPORINE) SOLUTION [NOVARTIS ANIMAL HEALTH US, INC.]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ATOPICA FOR CATS (CYCLOSPORINE) SOLUTION [NOVARTIS ANIMAL HEALTH US, INC.]6

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 1 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CycloSPORINE, ModfiedCYCLOSPORINEApotex Corp.5baaf78c-90f6-abcf-52c8-814490f3cf9f2026-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 83HN0GTJ6D
CyclosporineCYCLOSPORINEStrides Pharma Science Limitedc36132b2-3ec7-4c43-a25e-75cbdbe3d88d2026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 83HN0GTJ6D
NeoralCYCLOSPORINENovartis Pharmaceuticals Corporation94461af3-11f1-4670-95d4-2965b9538ae32026-08-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835886
unii: 83HN0GTJ6D
SandimmuneCYCLOSPORINENovartis Pharmaceuticals Corporation5e5926a7-1de0-4b54-a5c0-286b6200ff822026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 83HN0GTJ6D
CEQUACYCLOSPORINESun Pharmaceutical Industries, Inc.48c3d8a3-4289-4b52-9189-58b48596095c2026-06-15Warnings, Adverse reactionsExact identifier
unii: 83HN0GTJ6D
VerkaziaCYCLOSPORINEHarrow Eye, LLC48651d30-9e6e-74b0-e063-6294a90a83372026-06-03Warnings, Adverse reactionsExact identifier
unii: 83HN0GTJ6D
CYCLOSPORINECYCLOSPORINEUpsher-Smith Laboratories, LLCf7e4a2f0-ea2a-449b-bc6d-a6ea3d47b8502026-05-22Warnings, Adverse reactionsExact identifier
unii: 83HN0GTJ6D
CyclosporineCYCLOSPORINEApotex Corp.bfca7088-fe93-abb9-3ec3-e6f5710a69c62026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 83HN0GTJ6D
VEVYECYCLOSPORINE OPHTHALMIC SOLUTIONHarrow Eye, LLC0a60fccf-7e1b-44fe-e063-6394a90aadd52026-02-26Warnings, Adverse reactionsExact identifier
unii: 83HN0GTJ6D
CYCLOSPORINECYCLOSPORINESaptalis Pharmaceuticals, LLCff4dc2fc-667a-489a-b798-8d11cddfe7162025-12-09Warnings, Adverse reactionsExact identifier
unii: 83HN0GTJ6D
CYCLOSPORINECYCLOSPORINEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1952d4c7-a40e-4924-b669-c41400774cb92025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 83HN0GTJ6D
Restasis MultiDoseCYCLOSPORINEAllergan, Inc.7224d810-bb96-4682-a942-3355e6e8061a2025-08-21Warnings, Adverse reactionsExact identifier
unii: 83HN0GTJ6D
CyclosporineCYCLOSPORINEDevatis Inc.7bb2078d-17c2-4e6a-9f61-26c7ecbce9452025-02-17Warnings, Adverse reactionsExact identifier
unii: 83HN0GTJ6D
VerkaziaCYCLOSPORINESanten Incorporatedc795cd2f-89da-78e3-e053-2a95a90a94222025-01-17Warnings, Adverse reactionsExact identifier
unii: 83HN0GTJ6D
CyclosporineCYCLOSPORINEApotex Corp70c8a4a6-ebe2-457f-a626-400c338cec2d2024-09-23Warnings, Adverse reactionsExact identifier
unii: 83HN0GTJ6D
CyclosporineCYCLOSPORINEKVK-TECH, INC.a7040dc6-063b-40ee-8f2a-153e87b084302024-09-23Warnings, Adverse reactionsExact identifier
unii: 83HN0GTJ6D
RESTASISCYCLOSPORINEAllergan, Inc.8e24af2b-bc1c-4849-94f2-6df950cdca892024-09-09Warnings, Adverse reactionsExact identifier
unii: 83HN0GTJ6D
CYCLOSPORINECYCLOSPORINELupin Pharmaceuticals, Inc.9aca2026-af86-4e97-925e-c202b87c46ac2024-09-01Warnings, Adverse reactionsExact identifier
unii: 83HN0GTJ6D
GengrafCYCLOSPORINEAbbVie Inc.e896cbfe-4745-4088-82a3-8dc10b75c41f2024-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 83HN0GTJ6D
CyclosporineCYCLOSPORINETeva Pharmaceuticals USA, Inc.f3dc2a50-1084-4190-a6f3-37034a04db862024-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 835886
unii: 83HN0GTJ6D

Reported adverse events (FAERS/openFDA)#

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