FDA.reportPublic FDA data

Cyclosporin A

Manufacturer
AMERICAN PHARMACEUTICAL INGREDIENTS LLC
Effective date
2013-10-31
Label type
BULK INGREDIENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:47:49

Label at a glance#

ProductCyclosporin A
Active ingredientCYCLOSPORINE
Label structure1 sections

Label contents#

Full prescribing information#

PRINCIPAL DISPLAY PANEL – BULK PRODUCT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1be408a0-e15a-4092-b35e-4e294e65196fProduct name320240216
b3fdee3e-0c46-442f-aad5-aa71941d5621Product name120231023
78fb0708-fce5-decd-6611-5a9fbe3e3decProduct name320230327
54840517-000d-4fcb-b976-a6ddd102faa0Product name120220120
a5ba3bd0-8411-4005-ac3b-a41d8ee0633aProduct name120181029
b1c0d609-8b97-06ee-2cd0-5652a4b1d019Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58597-7011-3Cyclosporin A10000 g in 1 CELLO PACKPOWDER100001
58597-7011-8Cyclosporin A1000 g in 1 CONTAINERPOWDER10001
58597-7011-9Cyclosporin A5000 g in 1 CONTAINERPOWDER50001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58597-7011CYCLOSPORIN A POWDER [AMERICAN PHARMACEUTICAL INGREDIENTS LLC]13 package rows20131031_8157fbb0-d9da-4983-89c2-e4ac641d1346.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CYCLOSPORINEACTIVE INGREDIENT83HN0GTJ6D1
CYCLOSPORINEACTIVE MOIETY83HN0GTJ6D1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58597-701158597-7011-8, 58597-7011-9, 58597-7011-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
CYCLOSPORINE83HN0GTJ6DACTIB

Source Document#

Source XML

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 · 25 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 reactionsName fallback
generic name: CYCLOSPORINE
CyclosporineCYCLOSPORINEStrides Pharma Science Limitedc36132b2-3ec7-4c43-a25e-75cbdbe3d88d2026-08-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CYCLOSPORINE
NeoralCYCLOSPORINENovartis Pharmaceuticals Corporation94461af3-11f1-4670-95d4-2965b9538ae32026-08-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CYCLOSPORINE
SandimmuneCYCLOSPORINENovartis Pharmaceuticals Corporation5e5926a7-1de0-4b54-a5c0-286b6200ff822026-07-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CYCLOSPORINE
CEQUACYCLOSPORINESun Pharmaceutical Industries, Inc.48c3d8a3-4289-4b52-9189-58b48596095c2026-06-15Warnings, Adverse reactionsName fallback
generic name: CYCLOSPORINE
VerkaziaCYCLOSPORINEHarrow Eye, LLC48651d30-9e6e-74b0-e063-6294a90a83372026-06-03Warnings, Adverse reactionsName fallback
generic name: CYCLOSPORINE
CYCLOSPORINECYCLOSPORINEUpsher-Smith Laboratories, LLCf7e4a2f0-ea2a-449b-bc6d-a6ea3d47b8502026-05-22Warnings, Adverse reactionsName fallback
generic name: CYCLOSPORINE
CyclosporineCYCLOSPORINEApotex Corp.bfca7088-fe93-abb9-3ec3-e6f5710a69c62026-04-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CYCLOSPORINE
CYCLOSPORINECYCLOSPORINESaptalis Pharmaceuticals, LLCff4dc2fc-667a-489a-b798-8d11cddfe7162025-12-09Warnings, Adverse reactionsName fallback
generic name: CYCLOSPORINE
CYCLOSPORINECYCLOSPORINEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1952d4c7-a40e-4924-b669-c41400774cb92025-12-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CYCLOSPORINE
Restasis MultiDoseCYCLOSPORINEAllergan, Inc.7224d810-bb96-4682-a942-3355e6e8061a2025-08-21Warnings, Adverse reactionsName fallback
generic name: CYCLOSPORINE
CyclosporineCYCLOSPORINEDevatis Inc.7bb2078d-17c2-4e6a-9f61-26c7ecbce9452025-02-17Warnings, Adverse reactionsName fallback
generic name: CYCLOSPORINE
VerkaziaCYCLOSPORINESanten Incorporatedc795cd2f-89da-78e3-e053-2a95a90a94222025-01-17Warnings, Adverse reactionsName fallback
generic name: CYCLOSPORINE
CyclosporineCYCLOSPORINEApotex Corp70c8a4a6-ebe2-457f-a626-400c338cec2d2024-09-23Warnings, Adverse reactionsName fallback
generic name: CYCLOSPORINE
CyclosporineCYCLOSPORINEKVK-TECH, INC.a7040dc6-063b-40ee-8f2a-153e87b084302024-09-23Warnings, Adverse reactionsName fallback
generic name: CYCLOSPORINE
RESTASISCYCLOSPORINEAllergan, Inc.8e24af2b-bc1c-4849-94f2-6df950cdca892024-09-09Warnings, Adverse reactionsName fallback
generic name: CYCLOSPORINE
CYCLOSPORINECYCLOSPORINELupin Pharmaceuticals, Inc.9aca2026-af86-4e97-925e-c202b87c46ac2024-09-01Warnings, Adverse reactionsName fallback
generic name: CYCLOSPORINE
GengrafCYCLOSPORINEAbbVie Inc.e896cbfe-4745-4088-82a3-8dc10b75c41f2024-08-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CYCLOSPORINE
CyclosporineCYCLOSPORINETeva Pharmaceuticals USA, Inc.f3dc2a50-1084-4190-a6f3-37034a04db862024-07-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CYCLOSPORINE
CyclosporineCYCLOSPORINEDr. Reddy's Laboratories Inc64ec430a-e930-145c-e766-13fb49b646442024-06-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CYCLOSPORINE

Reported adverse events (FAERS/openFDA)#

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