FDA.reportPublic FDA data

APREPITANT

Product NDC
13668-592
11-digit product format
136680592
Labeler code
13668
Product ID
13668-592_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
80 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
APREPITANT80 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
13668-592-83APREPITANT2 in 1 BLISTER PACKCAPSULE28
13668-592-84APREPITANT2 in 1 CARTONCAPSULE28
13668-592-85APREPITANT1 in 1 BLISTER PACKCAPSULE18
13668-592-86APREPITANT3 in 1 CARTONCAPSULE38

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-592-83EA - Each13668-592c47f357c-bed5-4311-87df-616a87211e2b12022-10-06
13668-592-84EA - Each13668-59288cc9131-ea3a-42c1-bc91-baf8ed3f9a1012021-02-05
13668-592-85EA - Each13668-59207762cfc-e61e-4da9-b8de-8488825c9c1f12022-09-12
13668-592-86EA - Each13668-5929e9fc7b4-4260-46f4-86be-b1f49237f3fa12021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-592APREPITANT CAPSULE APREPITANT (APREPITANT) KIT [TORRENT PHARMACEUTICALS LIMITED]8Current NDC, Legacy NDC, 4 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
13668-592-83136680592832 in 1 BLISTER PACKHistorical
13668-592-84136680592842 BLISTER PACK in 1 CARTON (13668-592-84) / 1 CAPSULE in 1 BLISTER PACK (13668-592-85) 2 blister pack2020-10-210000-00-00NoNoCurrent
13668-592-85136680592851 in 1 BLISTER PACKHistorical
13668-592-86136680592863 BLISTER PACK in 1 CARTON (13668-592-86) / 2 CAPSULE in 1 BLISTER PACK (13668-592-83) 3 blister pack2020-10-210000-00-00NoNoCurrent