Home NDC 10122-410 Juxtapid
Product NDC 10122-410
11-digit product format 101220410
Labeler code 10122
Product ID 10122-410_b2c29de4-7331-4670-998a-69c91ad2fa7f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lomitapide mesylate
Dosage form CAPSULE
Route ORAL
Labeler Chiesi USA, Inc.
Application NDA203858
Marketing category NDA
Marketing start 2013-01-03
Substance LOMITAPIDE MESYLATE
Active strength 10 mg/1
Pharmacologic classes Cytochrome P450 3A4 Inhibitors [MoA], Microsomal Triglyceride Transfer Protein Inhibitor [EPC], Microsomal Triglyceride Transfer Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Juxtapid
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LOMITAPIDE MESYLATE 10 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii X4S83CP54E Rxcui 1364484, 1364490, 1364492, 1364494, 1364496, 1364498, 1648770, 1648772, 2738809, 2738811
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10122-410-28 Juxtapid 28 in 1 BOTTLE CAPSULE 28 25
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10122-410 JUXTAPID (LOMITAPIDE MESYLATE) CAPSULE [CHIESI USA, INC.] 23 Current NDC, 1 package rows 20240221_61a0be9d-ee58-43e0-b5cb-141011835081.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 10122-410-28 10122041028 28 CAPSULE in 1 BOTTLE (10122-410-28) 28 capsule 2013-01-28 No No Historical