FDA.reportPublic FDA data

Aprepitant

Product NDC
68462-583
11-digit product format
684620583
Labeler code
68462
Product ID
68462-583_41f97256-ac39-413d-8b2f-5fb7ad429143
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aprepitant
Dosage form
CAPSULE
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA207777
Marketing category
ANDA
Marketing start
2017-10-12
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
68462-583-11Aprepitant1 in 1 CARTONCAPSULE113
68462-583-11Aprepitant10 in 1 BLISTER PACKCAPSULE1013
68462-583-40Aprepitant1 in 1 CARTONCAPSULE113
68462-583-40Aprepitant1 in 1 BLISTER PACKCAPSULE113
68462-583-85Aprepitant5 in 1 CARTONCAPSULE513
68462-583-85Aprepitant1 in 1 BLISTER PACKCAPSULE113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-583-40EA - Each68462-58337a545a6-7aaf-45d5-a8f1-6f94ab35ec9f12017-11-06
68462-583-85EA - Each68462-583497b5f12-1b0b-4405-b693-6b353fb3287012017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-583APREPITANT CAPSULE APREPITANT KIT [GLENMARK PHARMACEUTICALS INC., USA]12Current NDC, Legacy NDC, 6 package rows20240706_d72e0e10-4557-41b0-b65d-d395468cad19.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) } PackGPCKd72e0e10-4557-41b0-b65d-d395468cad1913
754508aprepitant 125 MG (1), 80 MG (2) Oral Capsule 3 Count PackPSNd72e0e10-4557-41b0-b65d-d395468cad1913
403811aprepitant 125 MG Oral CapsulePSNd72e0e10-4557-41b0-b65d-d395468cad1913
644088aprepitant 40 MG Oral CapsulePSNd72e0e10-4557-41b0-b65d-d395468cad1913
403810aprepitant 80 MG Oral CapsulePSNd72e0e10-4557-41b0-b65d-d395468cad1913
403811aprepitant 125 MG Oral CapsuleSCDd72e0e10-4557-41b0-b65d-d395468cad1913
644088aprepitant 40 MG Oral CapsuleSCDd72e0e10-4557-41b0-b65d-d395468cad1913
403810aprepitant 80 MG Oral CapsuleSCDd72e0e10-4557-41b0-b65d-d395468cad1913

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-583-11684620583111 BLISTER PACK in 1 CARTON (68462-583-11) / 10 CAPSULE in 1 BLISTER PACK1 blister pack2017-10-120000-00-00NoNoCurrent
68462-583-40684620583401 BLISTER PACK in 1 CARTON (68462-583-40) / 1 CAPSULE in 1 BLISTER PACK1 blister pack2017-10-120000-00-00NoNoCurrent
68462-583-85684620583855 BLISTER PACK in 1 CARTON (68462-583-85) / 1 CAPSULE in 1 BLISTER PACK5 blister pack2017-10-120000-00-00NoNoCurrent