ANTARA

Product NDC
27437-110
11-digit product format
274370110
Labeler code
27437
Product ID
27437-110_945dde7a-9442-4421-8bc8-7f7d6de013f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FENOFIBRATE
Dosage form
CAPSULE
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
NDA021695
Marketing category
NDA
Marketing start
2009-09-25
Substance
FENOFIBRATE
Active strength
130 mg/1
Pharmacologic classes
Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ANTARA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FENOFIBRATE130 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU202363UOS
Rxcui483425, 483427, 578797, 578799

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
193bb7da-5c03-8f95-9048-23ef403846b0Product name320250616
fa35fb9a-7146-716b-13c8-bc1f60030232Product name920250114
cfc78bfa-7d55-47e5-aeb7-71cd79f5ca07Product name820231212
53d5b6b7-785a-4500-9460-263c7f8424b8Product name520210105
ed9d55d4-85bd-0ee7-5b4a-b705646a3a66Product name920200708
36a239c8-03fb-0083-81af-6c1afb195671Product name120140508
a0296d70-ca85-018c-84e8-cf3f630976b7Product name120140508
f2e3e9c8-a2f9-0cc3-a5a5-6dfd0279372aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27437-110-01ANTARA100 in 1 BOTTLECAPSULE10017
27437-110-06ANTARA30 in 1 BOTTLECAPSULE3017
27437-110-19ANTARA7 in 1 BOTTLECAPSULE717

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27437-110-01EA - Each27437-1109309240c-aaf1-4d81-8423-09b284fbf91212012-07-24
27437-110-06EA - Each27437-110aed0f902-7be4-48e6-b566-ecb12f66fed012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FENOFIBRATEACTIVE INGREDIENTU202363UOSANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]5
FENOFIBRATEACTIVE MOIETYU202363UOSANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]5
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]5
GELATININACTIVE INGREDIENT2G86QN327LANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]5
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62ANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]5
SHELLACINACTIVE INGREDIENT46N107B71OANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]5
SUCROSEINACTIVE INGREDIENTC151H8M554ANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]5
SULFUR DIOXIDEINACTIVE INGREDIENT0UZA3422Q4ANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]5
TALCINACTIVE INGREDIENT7SEV7J4R1UANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27437-110ANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMACEUTICALS, INC.]15Current NDC, Legacy NDC, 3 package rows20240821_24790a18-0291-4b88-a724-acac43b616ce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
578797Antara 130 MG Oral CapsulePSN24790a18-0291-4b88-a724-acac43b616ce17
578799Antara 43 MG Oral CapsulePSN24790a18-0291-4b88-a724-acac43b616ce17
483425fenofibrate 130 MG Oral CapsulePSN24790a18-0291-4b88-a724-acac43b616ce17
483427fenofibrate 43 MG Oral CapsulePSN24790a18-0291-4b88-a724-acac43b616ce17
578797fenofibrate 130 MG Oral Capsule [Antara]SBD24790a18-0291-4b88-a724-acac43b616ce17
578799fenofibrate 43 MG Oral Capsule [Antara]SBD24790a18-0291-4b88-a724-acac43b616ce17
483425fenofibrate 130 MG Oral CapsuleSCD24790a18-0291-4b88-a724-acac43b616ce17
483427fenofibrate 43 MG Oral CapsuleSCD24790a18-0291-4b88-a724-acac43b616ce17
578797Antara 130 MG Oral CapsuleSY24790a18-0291-4b88-a724-acac43b616ce17
578799Antara 43 MG Oral CapsuleSY24790a18-0291-4b88-a724-acac43b616ce17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27437-110-0127437011001100 CAPSULE in 1 BOTTLE (27437-110-01) 100 capsule2009-09-250000-00-00NoNoCurrent
27437-110-062743701100630 CAPSULE in 1 BOTTLE (27437-110-06) 30 capsule2009-09-250000-00-00NoNoCurrent
27437-110-19274370110197 CAPSULE in 1 BOTTLE (27437-110-19) 7 capsule2009-09-250000-00-00NoNoCurrent