FDA.reportPublic FDA data

Aprepitant

Product NDC
68001-666
11-digit product format
680010666
Labeler code
68001
Product ID
68001-666_4e00638d-1cbc-f20f-e063-6294a90ac14c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aprepitant
Dosage form
CAPSULE
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA207777
Marketing category
ANDA
Marketing start
2026-01-29
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
2027-12-31
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
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
68001-666-01Aprepitant1 in 1 BLISTER PACKCAPSULE12
68001-666-01Aprepitant1 in 1 CARTONCAPSULE12
68001-666-17Aprepitant5 in 1 CARTONCAPSULE52
68001-666-17Aprepitant1 in 1 BLISTER PACKCAPSULE12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
754508{1 (aprepitant 125 MG Oral Capsule) / 2 (aprepitant 80 MG Oral Capsule) } PackGPCKa78aaa00-a46b-4f9e-a415-2fca9e9a4fb42
754508aprepitant 125 MG (1), 80 MG (2) Oral Capsule 3 Count PackPSNa78aaa00-a46b-4f9e-a415-2fca9e9a4fb42
403811aprepitant 125 MG Oral CapsulePSNa78aaa00-a46b-4f9e-a415-2fca9e9a4fb42
644088aprepitant 40 MG Oral CapsulePSNa78aaa00-a46b-4f9e-a415-2fca9e9a4fb42
403810aprepitant 80 MG Oral CapsulePSNa78aaa00-a46b-4f9e-a415-2fca9e9a4fb42
403811aprepitant 125 MG Oral CapsuleSCDa78aaa00-a46b-4f9e-a415-2fca9e9a4fb42
644088aprepitant 40 MG Oral CapsuleSCDa78aaa00-a46b-4f9e-a415-2fca9e9a4fb42
403810aprepitant 80 MG Oral CapsuleSCDa78aaa00-a46b-4f9e-a415-2fca9e9a4fb42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68001-666-01680010666011 BLISTER PACK in 1 CARTON (68001-666-01) / 1 CAPSULE in 1 BLISTER PACK1 blister pack2026-01-29NoNoCurrent
68001-666-17680010666175 BLISTER PACK in 1 CARTON (68001-666-17) / 1 CAPSULE in 1 BLISTER PACK5 blister pack2026-02-02NoNoCurrent