42385-944 : Fenofibric Acid Delayed-release Delayed-release 45 mg Oral Capsule, Delayed Release

NDC:	42385-944
Labeler:	Laurus Labs Limited
Product Type:	Human Prescription Drug
Drug Name:	Fenofibric Acid Delayed-release
Dosage Form:	Oral Capsule, Delayed Release
Application #:	ANDA211626
Rev. Date:	Aug 24, 2020

Appearance:

Markings:	167
Shapes:	Capsule
Colors:	Brown
Size (mm):	16
Segments: ^*	1
^* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

42385-944-11: 1000 CAPSULE, DELAYED RELEASE IN 1 BOTTLE (42385‑944‑11)
42385-944-30: 30 CAPSULE, DELAYED RELEASE IN 1 BOTTLE (42385‑944‑30)
42385-944-90: 90 CAPSULE, DELAYED RELEASE IN 1 BOTTLE (42385‑944‑90)

Active Ingredients:

Fenofibric Acid

Dosage Strength:

45 mg

Inactive Ingredients:

Ammonia
Ferric Oxide Red
Ferric Oxide Yellow
Ferrosoferric Oxide
Gelatin
Hydroxypropyl Cellulose (90000 Wamw)
Hypromellose 2208 (15000 Mpa.s)
Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type a
Polysorbate 80
Potassium Hydroxide
Povidone K30
Propylene Glycol
Shellac
Silicon Dioxide
Sodium Lauryl Sulfate
Sodium Stearyl Fumarate
Talc
Titanium Dioxide
Triethyl Citrate /

Pharmaceutical Classes:

Peroxisome Proliferator Receptor alpha Agonist [EPC]

NDC QR Code

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NDC 42385-944 QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.