FDA.reportPublic FDA data

Cyclosporine

Product NDC
75907-048
11-digit product format
759070048
Labeler code
75907
Product ID
75907-048_d94fae26-e557-7f8f-1755-846c8f091506
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclosporine
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc
Application
ANDA065044
Marketing category
ANDA
Marketing start
2024-07-01
Substance
CYCLOSPORINE
Active strength
100 mg/1
Pharmacologic classes
Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cyclosporine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOSPORINE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii83HN0GTJ6D
Rxcui241834, 835894

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
75907-048-30Cyclosporine30 in 1 BOXCAPSULE, LIQUID FILLED301
75907-048-81Cyclosporine1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75907-048-30EA - Each75907-0481a873a49-c909-4d43-9c47-98957ac8582d12025-05-14
75907-048-81EA - Each75907-0487ca65a3f-e9b6-41a9-be3c-6b34ee67e10312025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75907-048CYCLOSPORINE CAPSULE, LIQUID FILLED [DR. REDDY'S LABORATORIES INC]1Current NDC, 2 package rows20240701_64ec430a-e930-145c-e766-13fb49b64644.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
241834cycloSPORINE, modified 100 MG Oral CapsulePSN64ec430a-e930-145c-e766-13fb49b646441
835894cycloSPORINE, modified 25 MG Oral CapsulePSN64ec430a-e930-145c-e766-13fb49b646441
241834cyclosporine, modified 100 MG Oral CapsuleSCD64ec430a-e930-145c-e766-13fb49b646441
835894cyclosporine, modified 25 MG Oral CapsuleSCD64ec430a-e930-145c-e766-13fb49b646441

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75907-048-307590700483030 BLISTER PACK in 1 BOX (75907-048-30) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (75907-048-81) 30 blister pack2024-07-01NoNoHistorical
75907-048-81759070048811 in 1 BLISTER PACKHistorical