FDA.reportPublic FDA data

Aprepitant

Product NDC
0781-2322
11-digit product format
007812322
Labeler code
0781
Product ID
0781-2322_a194823e-5961-4bc0-b18f-2f63d3cbb9c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
aprepitant
Dosage form
CAPSULE
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA090999
Marketing category
ANDA
Marketing start
2016-12-27
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
APREPITANT80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1NF15YR6UY
Rxcui403810, 403811, 644088, 754508

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
0781-2322-06Aprepitant6 in 1 BLISTER PACKCAPSULE615
0781-2322-46Aprepitant2 in 1 DOSE PACKCAPSULE215
0781-2322-68Aprepitant1 in 1 CARTONCAPSULE115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-2322-46EA - Each0781-232237547310-64e5-45da-9aea-88d45b03f26312017-03-06
0781-2322-68EA - Each0781-2322fdc6d739-147f-427e-a51e-83e8bfb68c5f12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-2322APREPITANT CAPSULE APREPITANT KIT [SANDOZ INC]15Current NDC, Legacy NDC, 3 package rows20250224_f58b8944-93ee-4be1-a238-cc0061ddd93a.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) } PackGPCKf58b8944-93ee-4be1-a238-cc0061ddd93a15
754508aprepitant 125 MG (1), 80 MG (2) Oral Capsule 3 Count PackPSNf58b8944-93ee-4be1-a238-cc0061ddd93a15
403811aprepitant 125 MG Oral CapsulePSNf58b8944-93ee-4be1-a238-cc0061ddd93a15
644088aprepitant 40 MG Oral CapsulePSNf58b8944-93ee-4be1-a238-cc0061ddd93a15
403810aprepitant 80 MG Oral CapsulePSNf58b8944-93ee-4be1-a238-cc0061ddd93a15
403811aprepitant 125 MG Oral CapsuleSCDf58b8944-93ee-4be1-a238-cc0061ddd93a15
644088aprepitant 40 MG Oral CapsuleSCDf58b8944-93ee-4be1-a238-cc0061ddd93a15
403810aprepitant 80 MG Oral CapsuleSCDf58b8944-93ee-4be1-a238-cc0061ddd93a15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-2322-06007812322066 in 1 BLISTER PACKHistorical
0781-2322-46007812322462 CAPSULE in 1 DOSE PACK (0781-2322-46) 2 capsule2016-12-270000-00-00NoNoCurrent
0781-2322-68007812322681 BLISTER PACK in 1 CARTON (0781-2322-68) / 6 CAPSULE in 1 BLISTER PACK (0781-2322-06) 1 blister pack2016-12-270000-00-00NoNoCurrent