FDA.reportPublic FDA data

APREPITANT

Product NDC
51407-701
11-digit product format
514070701
Labeler code
51407
Product ID
51407-701_4c9db5a6-88e7-5f5a-e063-6294a90acb0e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
APREPITANT
Dosage form
CAPSULE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
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
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
51407-701-01APREPITANT1 in 1 CARTONCAPSULE13
51407-701-05APREPITANT5 in 1 CARTONCAPSULE53
51407-701-11APREPITANT1 in 1 BLISTER PACKCAPSULE13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
754508{1 (aprepitant 125 MG Oral Capsule) / 2 (aprepitant 80 MG Oral Capsule) } PackGPCK377c3ecb-fdec-dde4-e063-6294a90a29bd3
754508aprepitant 125 MG (1), 80 MG (2) Oral Capsule 3 Count PackPSN377c3ecb-fdec-dde4-e063-6294a90a29bd3
403811aprepitant 125 MG Oral CapsulePSN377c3ecb-fdec-dde4-e063-6294a90a29bd3
644088aprepitant 40 MG Oral CapsulePSN377c3ecb-fdec-dde4-e063-6294a90a29bd3
403810aprepitant 80 MG Oral CapsulePSN377c3ecb-fdec-dde4-e063-6294a90a29bd3
403811aprepitant 125 MG Oral CapsuleSCD377c3ecb-fdec-dde4-e063-6294a90a29bd3
644088aprepitant 40 MG Oral CapsuleSCD377c3ecb-fdec-dde4-e063-6294a90a29bd3
403810aprepitant 80 MG Oral CapsuleSCD377c3ecb-fdec-dde4-e063-6294a90a29bd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51407-701-01514070701011 BLISTER PACK in 1 CARTON (51407-701-01) / 1 CAPSULE in 1 BLISTER PACK (51407-701-11) 1 blister pack2025-06-11NoNoCurrent
51407-701-05514070701055 BLISTER PACK in 1 CARTON (51407-701-05) / 1 CAPSULE in 1 BLISTER PACK (51407-701-11) 5 blister pack2025-06-11NoNoCurrent
51407-701-11514070701111 in 1 BLISTER PACKHistorical