FDA.reportPublic FDA data

APREPITANT

Product NDC
13668-593
11-digit product format
136680593
Labeler code
13668
Product ID
13668-593_13e87c01-b873-4d28-a5b3-3a51e49d4dd9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
APREPITANT
Dosage form
CAPSULE
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA211835
Marketing category
ANDA
Marketing start
2020-10-21
Substance
APREPITANT
Active strength
125 mg/1
Pharmacologic classes
Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], Substance P/Neurokinin-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
APREPITANT125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1NF15YR6UY

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2abc3e32-ae1f-4dec-be1c-0c39ac95b38eProduct name720240514
5d352eda-d4de-4572-9a3f-32d6fd204f9aProduct name120230911
3a5d67cc-4a03-45a3-8d74-5aeb67631be4Product name120230831
85fc66a9-58b2-e194-7cdb-89ff44dcf3e6Product name420210518
9f9a82fd-fcee-442f-9233-7f2d2f9f4568Product name120180108

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13668-593-80APREPITANT1 in 1 BLISTER PACKCAPSULE18
13668-593-86APREPITANT6 in 1 CARTONCAPSULE68

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-593-80EA - Each13668-5936990bf21-7af7-4a1b-a9f5-ee5b9db5b5d312025-05-14
13668-593-86EA - Each13668-593f9209158-843f-4a3a-aea9-ef7cd8aaefb012021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-593APREPITANT CAPSULE APREPITANT (APREPITANT) KIT [TORRENT PHARMACEUTICALS LIMITED]8Current NDC, Legacy NDC, 2 package rows20241012_af9b6086-4bf2-472c-8740-4134eaaebace.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
754508{1 (aprepitant 125 MG Oral Capsule) / 2 (aprepitant 80 MG Oral Capsule) } PackGPCKaf9b6086-4bf2-472c-8740-4134eaaebace8
754508aprepitant 125 MG (1), 80 MG (2) Oral Capsule 3 Count PackPSNaf9b6086-4bf2-472c-8740-4134eaaebace8
403811aprepitant 125 MG Oral CapsulePSNaf9b6086-4bf2-472c-8740-4134eaaebace8
644088aprepitant 40 MG Oral CapsulePSNaf9b6086-4bf2-472c-8740-4134eaaebace8
403810aprepitant 80 MG Oral CapsulePSNaf9b6086-4bf2-472c-8740-4134eaaebace8
403811aprepitant 125 MG Oral CapsuleSCDaf9b6086-4bf2-472c-8740-4134eaaebace8
644088aprepitant 40 MG Oral CapsuleSCDaf9b6086-4bf2-472c-8740-4134eaaebace8
403810aprepitant 80 MG Oral CapsuleSCDaf9b6086-4bf2-472c-8740-4134eaaebace8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-593-80136680593801 in 1 BLISTER PACKHistorical
13668-593-86136680593866 BLISTER PACK in 1 CARTON (13668-593-86) / 1 CAPSULE in 1 BLISTER PACK (13668-593-80) 6 blister pack2020-10-210000-00-00NoNoCurrent