FDA.reportPublic FDA data

Juxtapid

Product NDC
10122-430
11-digit product format
101220430
Labeler code
10122
Product ID
10122-430_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
30 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
IngredientStrength
LOMITAPIDE MESYLATE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4S83CP54E
Rxcui1364484, 1364490, 1364492, 1364494, 1364496, 1364498, 1648770, 1648772, 2738809, 2738811

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
db1e0578-c863-24bf-85ef-9cbb5c541fbdProduct name220150507

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10122-430-28Juxtapid28 in 1 BOTTLECAPSULE2825

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10122-430-28EA - Each10122-430a2bcf77a-20b5-4bc8-a232-b7c9bd48d97712024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10122-430JUXTAPID (LOMITAPIDE MESYLATE) CAPSULE [CHIESI USA, INC.]23Current NDC, 1 package rows20240221_61a0be9d-ee58-43e0-b5cb-141011835081.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1364490Juxtapid 10 MG Oral CapsulePSN61a0be9d-ee58-43e0-b5cb-14101183508125
2738811Juxtapid 2 MG Oral CapsulePSN61a0be9d-ee58-43e0-b5cb-14101183508125
1364494Juxtapid 20 MG Oral CapsulePSN61a0be9d-ee58-43e0-b5cb-14101183508125
1648772Juxtapid 30 MG Oral CapsulePSN61a0be9d-ee58-43e0-b5cb-14101183508125
1364498Juxtapid 5 MG Oral CapsulePSN61a0be9d-ee58-43e0-b5cb-14101183508125
1364484lomitapide 10 MG Oral CapsulePSN61a0be9d-ee58-43e0-b5cb-14101183508125
2738809lomitapide 2 MG Oral CapsulePSN61a0be9d-ee58-43e0-b5cb-14101183508125
1364492lomitapide 20 MG Oral CapsulePSN61a0be9d-ee58-43e0-b5cb-14101183508125
1648770lomitapide 30 MG Oral CapsulePSN61a0be9d-ee58-43e0-b5cb-14101183508125
1364496lomitapide 5 MG Oral CapsulePSN61a0be9d-ee58-43e0-b5cb-14101183508125
1364490lomitapide 10 MG Oral Capsule [Juxtapid]SBD61a0be9d-ee58-43e0-b5cb-14101183508125
2738811lomitapide 2 MG Oral Capsule [Juxtapid]SBD61a0be9d-ee58-43e0-b5cb-14101183508125
1364494lomitapide 20 MG Oral Capsule [Juxtapid]SBD61a0be9d-ee58-43e0-b5cb-14101183508125
1648772lomitapide 30 MG Oral Capsule [Juxtapid]SBD61a0be9d-ee58-43e0-b5cb-14101183508125
1364498lomitapide 5 MG Oral Capsule [Juxtapid]SBD61a0be9d-ee58-43e0-b5cb-14101183508125
1364484lomitapide 10 MG Oral CapsuleSCD61a0be9d-ee58-43e0-b5cb-14101183508125
2738809lomitapide 2 MG Oral CapsuleSCD61a0be9d-ee58-43e0-b5cb-14101183508125
1364492lomitapide 20 MG Oral CapsuleSCD61a0be9d-ee58-43e0-b5cb-14101183508125
1648770lomitapide 30 MG Oral CapsuleSCD61a0be9d-ee58-43e0-b5cb-14101183508125
1364496lomitapide 5 MG Oral CapsuleSCD61a0be9d-ee58-43e0-b5cb-14101183508125
1364490Juxtapid (as lomitapide mesylate) 10 MG Oral CapsuleSY61a0be9d-ee58-43e0-b5cb-14101183508125
1364494Juxtapid (as lomitapide mesylate) 20 MG Oral CapsuleSY61a0be9d-ee58-43e0-b5cb-14101183508125
1364498Juxtapid (as lomitapide mesylate) 5 MG Oral CapsuleSY61a0be9d-ee58-43e0-b5cb-14101183508125
1364490Juxtapid 10 MG Oral CapsuleSY61a0be9d-ee58-43e0-b5cb-14101183508125
2738811Juxtapid 2 MG Oral CapsuleSY61a0be9d-ee58-43e0-b5cb-14101183508125
1364494Juxtapid 20 MG Oral CapsuleSY61a0be9d-ee58-43e0-b5cb-14101183508125
1648772Juxtapid 30 MG (as lomitapide mesylate) Oral CapsuleSY61a0be9d-ee58-43e0-b5cb-14101183508125
1648772Juxtapid 30 MG Oral CapsuleSY61a0be9d-ee58-43e0-b5cb-14101183508125
1364498Juxtapid 5 MG Oral CapsuleSY61a0be9d-ee58-43e0-b5cb-14101183508125
1364484lomitapide (as lomitapide mesylate) 10 MG Oral CapsuleSY61a0be9d-ee58-43e0-b5cb-14101183508125
1364492lomitapide (as lomitapide mesylate) 20 MG Oral CapsuleSY61a0be9d-ee58-43e0-b5cb-14101183508125
1364496lomitapide (as lomitapide mesylate) 5 MG Oral CapsuleSY61a0be9d-ee58-43e0-b5cb-14101183508125
1648770lomitapide 30 MG (as lomitapide mesylate) Oral CapsuleSY61a0be9d-ee58-43e0-b5cb-14101183508125

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10122-430-281012204302828 CAPSULE in 1 BOTTLE (10122-430-28) 28 capsule2015-06-22NoNoHistorical