FDA.reportPublic FDA data

EGATEN

Product NDC
0078-0937
11-digit product format
000780937
Labeler code
0078
Product ID
0078-0937_59dff6dc-c0b0-4f26-9738-32f8a6540033
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
triclabendazole
Dosage form
TABLET
Route
ORAL
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA208711
Marketing category
NDA
Marketing start
2019-02-13
Substance
TRICLABENDAZOLE
Active strength
250 mg/1
Pharmacologic classes
Anthelmintic [EPC], Anthelmintics [CS], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2A6 Inhibitors [MoA], Cytochrome P450 2B6 Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A 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
EGATEN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRICLABENDAZOLE250 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e10b03a1-8e45-4bc3-9626-8b78c34f131bProduct name120190612

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-0937-91EGATEN4 in 1 BLISTER PACKTABLET411

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0937-91EA - Each0078-0937be5501ce-640a-48d4-b218-8915bc3ae7e512019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0937EGATEN (TRICLABENDAZOLE) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]11Current NDC, Legacy NDC, 1 package rows20250308_5552884e-10ea-450c-9658-d3d4f33c946e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2118612Egaten 250 MG Oral TabletPSN5552884e-10ea-450c-9658-d3d4f33c946e11
2118606triclabendazole 250 MG Oral TabletPSN5552884e-10ea-450c-9658-d3d4f33c946e11
2118612triclabendazole 250 MG Oral Tablet [Egaten]SBD5552884e-10ea-450c-9658-d3d4f33c946e11
2118606triclabendazole 250 MG Oral TabletSCD5552884e-10ea-450c-9658-d3d4f33c946e11
2118612Egaten 250 MG Oral TabletSY5552884e-10ea-450c-9658-d3d4f33c946e11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0937-91000780937914 TABLET in 1 BLISTER PACK (0078-0937-91) 4 tablet2019-02-130000-00-00NoNoCurrent