FDA.reportPublic FDA data

APREPITANT

Product NDC
13668-591
11-digit product format
136680591
Labeler code
13668
Product ID
13668-591_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
40 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
APREPITANT40 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
13668-591-80APREPITANT1 in 1 BLISTER PACKCAPSULE18
13668-591-81APREPITANT1 in 1 CARTONCAPSULE18
13668-591-82APREPITANT5 in 1 CARTONCAPSULE58

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-591-80EA - Each13668-59156bf10cf-d6f2-437f-8c73-f93e8e269a3d12023-08-08
13668-591-81EA - Each13668-5912b11c456-32f8-48e5-b39f-287736e5831512021-02-05
13668-591-82EA - Each13668-591d073a9da-cec8-4190-9727-223ff20c90c012021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-591APREPITANT CAPSULE APREPITANT (APREPITANT) KIT [TORRENT PHARMACEUTICALS LIMITED]8Current NDC, Legacy NDC, 3 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
13668-591-80136680591801 in 1 BLISTER PACKHistorical
13668-591-81136680591811 BLISTER PACK in 1 CARTON (13668-591-81) / 1 CAPSULE in 1 BLISTER PACK (13668-591-80) 1 blister pack2020-10-210000-00-00NoNoCurrent
13668-591-82136680591825 BLISTER PACK in 1 CARTON (13668-591-82) / 1 CAPSULE in 1 BLISTER PACK (13668-591-80) 5 blister pack2020-10-210000-00-00NoNoCurrent