antara
Generic: fenofibrate
Labeler: lupin pharmaceuticals, inc.Drug Facts
Product Profile
Brand Name
antara
Generic Name
fenofibrate
Labeler
lupin pharmaceuticals, inc.
Dosage Form
CAPSULE
Routes
Active Ingredients
fenofibrate 30 mg/1
Manufacturer
Identifiers & Regulatory
Product NDC
27437-107
Product ID
27437-107_7ca6a804-2dff-43b3-848e-7a58b31fb268
Product Type
HUMAN PRESCRIPTION DRUG
Marketing Category
NDA
Application Number
NDA021695
Listing Expiration
2026-12-31
Marketing Start
2013-11-01
Pharmacologic Class
Established (EPC)
Mechanism of Action
Chemical Structure
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
27437107
Hyphenated Format
27437-107
Supplemental Identifiers
RxCUI
UPC
UNII
NUI
Packaging Origin
Original Packager
Resolved Product View
Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.
Resolved Identity
Brand Name
antara (source: ndc)
Generic Name
fenofibrate (source: ndc)
Application Number
NDA021695 (source: ndc)
Routes
source: ndc
Resolved Composition
Strengths
- 30 mg/1
Packaging
- 16 HOW SUPPLIED/STORAGE AND HANDLING Antara capsules are supplied as follows: Strength Description NDC Package Size (capsules per bottle) 30 mg size '4', 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 90 mg size '3' 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 NDC 27437 - 108 - 09 90 NDC 27437 - 108 - 01 100 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.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 27437-107-06 Antara (fenofibrate) Capsules 30 mg Rx only Container Label: Bottle of 30 Capsules NDC 27437-108-06 Antara (fenofibrate) Capsules 90 mg Rx only Container Label: Bottle of 90 Capsules Antara Capsules 30 mg-30 Capsules Container Pack 30mg-30s-pth Nagpur- 30_30 Antara Capsules 90 mg-30 Capsules Container Pack 90mg-30s-pth Nagpur- 90_90
Packages (0)
No package records.
Ingredients (1)
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
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