FDA.reportPublic FDA data

CYCLOSPORINE

Product NDC
24979-126
11-digit product format
249790126
Labeler code
24979
Product ID
24979-126_8bf257be-d4c8-4694-b62b-f05124d378d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclosporine
Dosage form
EMULSION
Route
OPHTHALMIC
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA209064
Marketing category
ANDA
Marketing start
2026-03-27
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209064-001CYCLOSPORINECYCLOSPORINE0.05%EMULSION / OPHTHALMICAB2026-01-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A209064-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A209064-001CYCLOSPORINE0.05%EMULSION / OPHTHALMICAB2026-01-21011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209064-001CYCLOSPORINE0.05%EMULSION / OPHTHALMICAB2026-01-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A209064-001AB1011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209064-001AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
CYCLOSPORINE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOSPORINE.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
83HN0GTJ6DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2572292Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f7e4a2f0-ea2a-449b-bc6d-a6ea3d47b850Available on FDA.report

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
24979-126-18CYCLOSPORINE60 in 1 CARTONEMULSION602
24979-126-18CYCLOSPORINE0.4 mL in 1 VIAL, SINGLE-USEEMULSION0.42
24979-126-19CYCLOSPORINE0.4 mL in 1 VIAL, SINGLE-USEEMULSION0.42
24979-126-19CYCLOSPORINE30 in 1 CARTONEMULSION302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24979-126-18EA - Each24979-126c028195e-058c-4f7b-bb59-0cf50c586a1112026-05-22
24979-126-19EA - Each24979-126f0281816-ecdd-4544-9d2b-53ab77c5a8ff12026-05-22

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CYCLOSPORINECYCLOSPORINEUpsher-Smith Laboratories, LLCf7e4a2f0-ea2a-449b-bc6d-a6ea3d47b8502026-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209064
application number: ANDA209064
ndc (product): 24979-126

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2572292cycloSPORINE 0.05 % in 0.4 ML Ophthalmic EmulsionPSNf7e4a2f0-ea2a-449b-bc6d-a6ea3d47b8502
25722920.4 ML cyclosporine 0.5 MG/ML Ophthalmic SuspensionSCDf7e4a2f0-ea2a-449b-bc6d-a6ea3d47b8502
2572292cyclosporine 0.05 % per 0.4 ML Ophthalmic EmulsionSYf7e4a2f0-ea2a-449b-bc6d-a6ea3d47b8502
2572292cyclosporine 0.5 MG/ML per 0.4 ML Ophthalmic EmulsionSYf7e4a2f0-ea2a-449b-bc6d-a6ea3d47b8502

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
24979-126-182497901261860 VIAL, SINGLE-USE in 1 CARTON (24979-126-18) / .4 mL in 1 VIAL, SINGLE-USE2026-03-27NoNoCurrent
24979-126-192497901261930 VIAL, SINGLE-USE in 1 CARTON (24979-126-19) / .4 mL in 1 VIAL, SINGLE-USE2026-03-27NoNoCurrent