FDA.reportPublic FDA data

CYCLOSPORINE

Product NDC
23155-838
11-digit product format
231550838
Labeler code
23155
Product ID
23155-838_15185077-eec3-40ca-a492-f500a05a045b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CYCLOSPORINE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA216046
Marketing category
ANDA
Marketing start
2022-11-30
Substance
CYCLOSPORINE
Active strength
50 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
CYCLOSPORINE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii83HN0GTJ6D
Rxcui241834, 835894, 835925

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
23155-838-11CYCLOSPORINE5 in 1 BLISTER PACKCAPSULE, LIQUID FILLED55
23155-838-30CYCLOSPORINE6 in 1 CARTONCAPSULE, LIQUID FILLED65

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-838-11EA - Each23155-838168f9b3a-0a61-4af3-b06a-5ce31f5369a712023-01-09
23155-838-30EA - Each23155-838adbe4f41-e803-481d-8a0e-902a5f2dde6f12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-838CYCLOSPORINE CAPSULE, LIQUID FILLED [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 2 package rows20240322_1952d4c7-a40e-4924-b669-c41400774cb9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
241834cycloSPORINE, modified 100 MG Oral CapsulePSN1952d4c7-a40e-4924-b669-c41400774cb95
835894cycloSPORINE, modified 25 MG Oral CapsulePSN1952d4c7-a40e-4924-b669-c41400774cb95
835925cycloSPORINE, modified 50 MG Oral CapsulePSN1952d4c7-a40e-4924-b669-c41400774cb95
241834cyclosporine, modified 100 MG Oral CapsuleSCD1952d4c7-a40e-4924-b669-c41400774cb95
835894cyclosporine, modified 25 MG Oral CapsuleSCD1952d4c7-a40e-4924-b669-c41400774cb95
835925cyclosporine, modified 50 MG Oral CapsuleSCD1952d4c7-a40e-4924-b669-c41400774cb95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-838-11231550838115 in 1 BLISTER PACKHistorical
23155-838-30231550838306 BLISTER PACK in 1 CARTON (23155-838-30) / 5 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (23155-838-11) 6 blister pack2022-11-300000-00-00NoNoCurrent