FDA.reportPublic FDA data

CYCLOSPORINE

Product NDC
71656-012
11-digit product format
716560012
Labeler code
71656
Product ID
71656-012_458a84bc-12a1-5159-e063-6394a90ac45c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CYCLOSPORINE
Dosage form
EMULSION
Route
OPHTHALMIC
Labeler
Saptalis Pharmaceuticals, LLC
Application
ANDA211943
Marketing category
ANDA
Marketing start
2025-12-12
Substance
CYCLOSPORINE
Active strength
.5 mg/mL
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
CYCLOSPORINE.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii83HN0GTJ6D
Rxcui2572292

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
71656-012-30CYCLOSPORINE5 in 1 POUCHEMULSION51
71656-012-30CYCLOSPORINE6 in 1 CARTONEMULSION61
71656-012-60CYCLOSPORINE12 in 1 CARTONEMULSION121
71656-012-60CYCLOSPORINE5 in 1 POUCHEMULSION51

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2572292cycloSPORINE 0.05 % in 0.4 ML Ophthalmic EmulsionPSNff4dc2fc-667a-489a-b798-8d11cddfe7161
25722920.4 ML cyclosporine 0.5 MG/ML Ophthalmic SuspensionSCDff4dc2fc-667a-489a-b798-8d11cddfe7161
2572292cyclosporine 0.05 % per 0.4 ML Ophthalmic EmulsionSYff4dc2fc-667a-489a-b798-8d11cddfe7161
2572292cyclosporine 0.5 MG/ML per 0.4 ML Ophthalmic EmulsionSYff4dc2fc-667a-489a-b798-8d11cddfe7161

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71656-012-30716560012306 POUCH in 1 CARTON (71656-012-30) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-DOSE6 pouch2025-12-12NoNoHistorical
71656-012-607165600126012 POUCH in 1 CARTON (71656-012-60) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-DOSE12 pouch2025-12-12NoNoHistorical