FDA.reportPublic FDA data

Cyclosporine

Product NDC
69238-1023
Requested package NDC
69238-1023-3
11-digit product format
692381023
Labeler code
69238
Product ID
69238-1023_068a8471-da9f-4790-ba57-fcaad1782a9e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclosporine
Dosage form
EMULSION
Route
OPHTHALMIC
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA211909
Marketing category
ANDA
Marketing start
2025-12-01
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69238-102369238-1023-3DDiscontinued by firm2026-08-11

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
A211909-001CYCLOSPORINECYCLOSPORINE0.05%EMULSION / OPHTHALMICAB2025-11-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211909-001AB

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 UTC2026-02A211909-001CYCLOSPORINE0.05%EMULSION / OPHTHALMICAB2025-11-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211909-001CYCLOSPORINE0.05%EMULSION / OPHTHALMICAB2025-11-2831067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211909-001CYCLOSPORINE0.05%EMULSION / OPHTHALMICAB2025-11-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211909-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211909-001AB131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211909-001AB1a50c72e98297…

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
69238-1023-3Cyclosporine3 in 1 CARTONEMULSION38
69238-1023-3Cyclosporine10 in 1 POUCHEMULSION108
69238-1023-6Cyclosporine10 in 1 POUCHEMULSION108
69238-1023-6Cyclosporine6 in 1 CARTONEMULSION68

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1023-3EA - Each69238-1023c3f6457a-bd47-467b-a0cf-28e8f84e828912026-05-22
69238-1023-6EA - Each69238-102335d74bfc-a1a6-46bb-8ec4-2bbc625340e312026-05-22
69238-1023-7EA - Each69238-10234d08b58c-40f5-4fa9-9d98-043b0abc882312026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2572292cycloSPORINE 0.05 % in 0.4 ML Ophthalmic EmulsionPSN5fd45474-d5de-4aa4-beb6-bef103fe521c8
25722920.4 ML cyclosporine 0.5 MG/ML Ophthalmic SuspensionSCD5fd45474-d5de-4aa4-beb6-bef103fe521c8
2572292cyclosporine 0.05 % per 0.4 ML Ophthalmic EmulsionSY5fd45474-d5de-4aa4-beb6-bef103fe521c8
2572292cyclosporine 0.5 MG/ML per 0.4 ML Ophthalmic EmulsionSY5fd45474-d5de-4aa4-beb6-bef103fe521c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69238-1023-3692381023033 POUCH in 1 CARTON (69238-1023-3) / 10 VIAL, SINGLE-USE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-USE3 pouch2025-12-01NoNoHistorical