Antara: Package Insert and Label Information (Page 4 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

ANTARA® (fenofibrate) Capsules, 30 mg are size ‘4’ capsules with opaque light green cap and opaque light green body, imprinted with LUPIN logo and “ANTARA” in black ink on body, and “30” in black ink on cap, containing white to off-white pellets.

NDC 27437 — 107 — 06 30’s Bottle

ANTARA® (fenofibrate) Capsules, 90 mg are size ‘3’ capsules with opaque dark green cap and opaque white body, imprinted with LUPIN logo and “ANTARA” in black ink on body, and “90” in black ink on cap, containing white to off-white pellets.

NDC 27437 — 108 — 06 30’s Bottle

NDC 27437 — 108 — 09 90’s Bottle

NDC 27437 — 108 — 01 100’s Bottle

Storage

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59°to 86°F) [see USP Controlled Room Temperature] in a tightly closed container.

17 PATIENT COUNSELING INFORMATION

Patients should be advised:

  • of the potential benefits and risks of Antara.
  • not to use Antara if there is a known hypersensitivity to fenofibrate or fenofibric acid.
  • that if they are taking coumarin anticoagulants, Antara may increase their anticoagulant effect, and increased monitoring may be necessary.
  • of medications that should not be taken in combination with Antara.
  • to continue to follow an appropriate lipid-modifying diet while taking Antara.
  • to take Antara once daily, without regard to food, at the prescribed dose swallowing each capsule whole.
  • to inform their physician of all medications, supplements, and herbal preparations they are taking and any change to their medical condition. Patients should also be advised to inform their physicians prescribing a new medication that they are taking Antara.
  • to inform their physician of symptoms of liver injury (e.g., jaundice, abnormal pain, nausea, malaise, dark urine, abnormal stool, pruritus); any muscle pain, tenderness, or weakness; onset of abdominal pain; or any other new symptoms.
  • to return to their physician’s office for routine monitoring.

Manufactured for:

Lupin Pharmaceuticals, Inc

Baltimore, Maryland 21202

United States.

MADE IN INDIA

Address Medical Inquiries to:

Lupin Pharmaceuticals Inc.

111 South Calvert Street, 21st Floor

Baltimore, MD 21202

or Call: 1-800-399-2561

Revised: May 2021 ID: 267515

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 27437-107-06

Antara (fenofibrate) Capsules

30 mg

Rx only

Container Label: Bottle of 30 Capsules

Antara Capsules 30 mg-30 Capsules Container Pack
(click image for full-size original)
30mg-30s-pth
(click image for full-size original)
Nagpur- 30_30
(click image for full-size original)

NDC 27437-108-06

Antara (fenofibrate) Capsules

90 mg

Rx only

Container Label: Bottle of 90 Capsules

Antara Capsules 90 mg-30 Capsules Container Pack
(click image for full-size original)
90mg-30s-pth
(click image for full-size original)
Nagpur- 90_90
(click image for full-size original)
ANTARA fenofibrate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:27437-107
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FENOFIBRATE (FENOFIBRIC ACID) FENOFIBRATE 30 mg
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10
DIMETHICONE
FD&C BLUE NO. 2
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
GELATIN
HYPROMELLOSES
LECITHIN, SOYBEAN
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
SUCROSE
SULFUR DIOXIDE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color GREEN (opaque light green cap and body) Score no score
Shape CAPSULE Size 15mm
Flavor Imprint Code LUPINlogo;ANTARA;30
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:27437-107-19 7 CAPSULE in 1 BOTTLE None
2 NDC:27437-107-06 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021695 11/01/2013
ANTARA fenofibrate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:27437-108
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FENOFIBRATE (FENOFIBRIC ACID) FENOFIBRATE 90 mg
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10
DIMETHICONE
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
FERROSOFERRIC OXIDE
GELATIN
HYPROMELLOSES
LECITHIN, SOYBEAN
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
SUCROSE
SULFUR DIOXIDE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color GREEN (opaque dark green cap and body) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code LUPINlogo;ANTARA;90
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:27437-108-19 7 CAPSULE in 1 BOTTLE None
2 NDC:27437-108-06 30 CAPSULE in 1 BOTTLE None
3 NDC:27437-108-09 90 CAPSULE in 1 BOTTLE None
4 NDC:27437-108-01 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021695 11/01/2013
Labeler — Lupin Pharmaceuticals, Inc. (089153071)
Registrant — LUPIN LIMITED (675923163)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 863645527 MANUFACTURE (27437-107), MANUFACTURE (27437-108), PACK (27437-107), PACK (27437-108)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 677600414 MANUFACTURE (27437-107), MANUFACTURE (27437-108), PACK (27437-107), PACK (27437-108)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 650759348 MANUFACTURE (27437-107), MANUFACTURE (27437-108), PACK (27437-107), PACK (27437-108)

Revised: 05/2021 Lupin Pharmaceuticals, Inc.

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