FDA.reportPublic FDA data

CYCLOSPORINE

Product NDC
68180-214
11-digit product format
681800214
Labeler code
68180
Product ID
68180-214_3dade5e6-5243-42a1-b1fa-0fb094e8da5f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclosporine
Dosage form
EMULSION
Route
OPHTHALMIC
Labeler
Lupin Pharmaceuticals, Inc.
Application
NDA050790
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2022-05-11
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
68180-214-30CYCLOSPORINE0.4 mL in 1 VIAL, SINGLE-USEEMULSION0.44
68180-214-30CYCLOSPORINE30 in 1 TRAYEMULSION304
68180-214-60CYCLOSPORINE0.4 mL in 1 VIAL, SINGLE-USEEMULSION0.44
68180-214-60CYCLOSPORINE60 in 1 TRAYEMULSION604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-214-30EA - Each68180-2143031b45e-9bcf-4792-b4ae-11e71b66b74212022-06-06
68180-214-60EA - Each68180-214405df1ec-210a-4cb0-8f15-822077e0e8dd12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-214CYCLOSPORINE EMULSION [LUPIN PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 4 package rows20240925_9aca2026-af86-4e97-925e-c202b87c46ac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2572292cycloSPORINE 0.05 % in 0.4 ML Ophthalmic EmulsionPSN9aca2026-af86-4e97-925e-c202b87c46ac4
25722920.4 ML cyclosporine 0.5 MG/ML Ophthalmic SuspensionSCD9aca2026-af86-4e97-925e-c202b87c46ac4
2572292cyclosporine 0.05 % per 0.4 ML Ophthalmic EmulsionSY9aca2026-af86-4e97-925e-c202b87c46ac4
2572292cyclosporine 0.5 MG/ML per 0.4 ML Ophthalmic EmulsionSY9aca2026-af86-4e97-925e-c202b87c46ac4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68180-214-306818002143030 VIAL, SINGLE-USE in 1 TRAY (68180-214-30) / .4 mL in 1 VIAL, SINGLE-USE2022-05-110000-00-00NoNoCurrent
68180-214-606818002146060 VIAL, SINGLE-USE in 1 TRAY (68180-214-60) / .4 mL in 1 VIAL, SINGLE-USE2022-05-110000-00-00NoNoCurrent