FDA.reportPublic FDA data

NDC 73377-197-03 - Cyclosporine A

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
73377-197
Requested NDC
73377-197-03
Package NDCs from labels
73377-197-02, 73377-197-03, 73377-197-01, 73377-197-04, 73377-197-05, 73377-197-06, 73377-197-07, 73377-197-08, 73377-197-09, 73377-197-10, 73377-197-11, 73377-197-12, 73377-197-13
Manufacturer
AX Pharmaceutical Corp
Effective date
2026-08-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cyclosporine A - AX Pharmaceutical CorpAX Pharmaceutical Corp2026-08-25BULK INGREDIENT - ANIMAL DRUG

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73377-197-01Cyclosporine A500 g in 1 JARPOWDER5008
73377-197-02Cyclosporine A1000 g in 1 JARPOWDER10008
73377-197-03Cyclosporine A100 g in 1 JARPOWDER1008
73377-197-04Cyclosporine A4000 g in 1 JARPOWDER40008
73377-197-05Cyclosporine A476 g in 1 JARPOWDER4768
73377-197-06Cyclosporine A433 g in 1 JARPOWDER4338
73377-197-07Cyclosporine A429 g in 1 JARPOWDER4298
73377-197-08Cyclosporine A415 g in 1 JARPOWDER4158
73377-197-09Cyclosporine A406 g in 1 JARPOWDER4068
73377-197-10Cyclosporine A473 g in 1 JARPOWDER4738
73377-197-11Cyclosporine A20000 g in 1 JARPOWDER200008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73377-197CYCLOSPORINE A POWDER [AX PHARMACEUTICAL CORP]711 package rows20241205_9f7b32d8-d55a-41b7-ac3b-409f01f87025.zip

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
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
unii: 83HN0GTJ6D

Reported adverse events (FAERS/openFDA)#

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