Antara

Product NDC
27437-107
11-digit product format
274370107
Labeler code
27437
Product ID
27437-107_7ca6a804-2dff-43b3-848e-7a58b31fb268
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fenofibrate
Dosage form
CAPSULE
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
NDA021695
Marketing category
NDA
Marketing start
2013-11-01
Substance
FENOFIBRATE
Active strength
30 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
FENOFIBRATE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU202363UOS
Rxcui1442163, 1442165, 1442168, 1442170

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
27437-107-06Antara30 in 1 BOTTLECAPSULE3016
27437-107-19Antara7 in 1 BOTTLECAPSULE716

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27437-107-06EA - Each27437-1077e3bfc70-5e52-41b3-9812-85a21408be1a12013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FENOFIBRATEACTIVE INGREDIENTU202363UOSANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]4
FENOFIBRATEACTIVE MOIETYU202363UOSANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]4
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]4
GELATININACTIVE INGREDIENT2G86QN327LANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]4
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62ANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]4
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]4
SHELLACINACTIVE INGREDIENT46N107B71OANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]4
SUCROSEINACTIVE INGREDIENTC151H8M554ANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]4
SULFUR DIOXIDEINACTIVE INGREDIENT0UZA3422Q4ANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]4
TALCINACTIVE INGREDIENT7SEV7J4R1UANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27437-107ANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMACEUTICALS, INC.]16Current NDC, Legacy NDC, 2 package rows20240823_12ebf783-64df-4ffa-9e84-f8fdf4d245d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1442165Antara 30 MG Oral CapsulePSN12ebf783-64df-4ffa-9e84-f8fdf4d245d416
1442170Antara 90 MG Oral CapsulePSN12ebf783-64df-4ffa-9e84-f8fdf4d245d416
1442163fenofibrate 30 MG Oral CapsulePSN12ebf783-64df-4ffa-9e84-f8fdf4d245d416
1442168fenofibrate 90 MG Oral CapsulePSN12ebf783-64df-4ffa-9e84-f8fdf4d245d416
1442165fenofibrate 30 MG Oral Capsule [Antara]SBD12ebf783-64df-4ffa-9e84-f8fdf4d245d416
1442170fenofibrate 90 MG Oral Capsule [Antara]SBD12ebf783-64df-4ffa-9e84-f8fdf4d245d416
1442163fenofibrate 30 MG Oral CapsuleSCD12ebf783-64df-4ffa-9e84-f8fdf4d245d416
1442168fenofibrate 90 MG Oral CapsuleSCD12ebf783-64df-4ffa-9e84-f8fdf4d245d416
1442165Antara 30 MG Oral CapsuleSY12ebf783-64df-4ffa-9e84-f8fdf4d245d416
1442170Antara 90 MG Oral CapsuleSY12ebf783-64df-4ffa-9e84-f8fdf4d245d416

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27437-107-062743701070630 CAPSULE in 1 BOTTLE (27437-107-06) 30 capsule2013-11-010000-00-00NoNoCurrent
27437-107-19274370107197 CAPSULE in 1 BOTTLE (27437-107-19) 7 capsule2013-11-010000-00-00NoNoCurrent