Beta carotene

Overview

Beta-carotene, with the molecular formula C40H56, belongs to the group of carotenoids consisting of isoprene units. The presence of long chains of conjugated double bonds donates beta-carotene with specific colors. It is the most abundant form of carotenoid and it is a precursor of the vitamin A. Beta-carotene is composed of two retinyl groups. It is an antioxidant that can be found in yellow, orange and green leafy vegetables and fruits. Under the FDA, beta-carotene is considered as a generally recognized as safe substance (GRAS).

Indication

Beta-carotene is FDA approved to be used as a nutrient supplement and to be even added in infant formula as a source of vitamin A. It is also approved to be used as a color additive for food products, drugs (with the label of "only as a color additive") and cosmetics. It is used commonly for the reduction of photosensitivity in patients with erythropoietic protoporphyria and other photosensitivity diseases.

Associated Conditions

Deficiency, Vitamin A

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
The Effect of Zinc, β-carotene, and Vitamin D3 in Preterm Delivery Through Placental MyD88, TRIF, NFkB, and IL-1β	2016/12/29	NCT03005496	Phase 4	Completed	Indonesia University
Arterial Disease Multifactorial Intervention Trial (ADMIT)	1999/10/28	NCT00000539	Phase 3	Completed	National Heart, Lung, and Blood Institute (NHLBI)
Women's Antioxidant and Folic Acid Cardiovascular Study (WAFACS)	1999/10/28	NCT00000541	Phase 2	Completed	Brigham and Women's Hospital
Randomized Trial of Beta-Carotene and Macular Degeneration	1999/09/24	NCT00000152	Phase 3	UNKNOWN	National Eye Institute (NEI)
Randomized Trials of Vitamin Supplements and Eye Disease	1999/09/24	NCT00000161	Phase 3	UNKNOWN	National Eye Institute (NEI)

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
PRENATAL PLUS	AvPAK	50268-677	ORAL	920 [iU] in 1 1	4/12/2022
Vitafol Fe Plus	Exeltis USA, Inc.	0642-7473	ORAL	330 ug in 1 1	2/14/2023
Floriva	BonGeo Pharmaceuticals, Inc.	52796-174	ORAL	1000 [iU] in 1 1	2/2/2024
PRENATAL PLUS	Amneal Pharmaceuticals LLC	65162-668	ORAL	920 [iU] in 1 1	3/29/2022
PNV 27-Ca/Fe/FA	Westminster Pharmaceuticals, LLC	69367-193	ORAL	400 [iU] in 1 1	5/27/2025
FolaWise	Redmont Pharmaceuticals, LLC	71741-406	ORAL	300 ug in 1 1	6/23/2025
Prenatal Plus Vitamins	Patrin Pharma, Inc.	39328-106	ORAL	276 ug in 1 1	1/13/2022
Floriva	BonGeo Pharmaceuticals, Inc.	52796-173	ORAL	1000 [iU] in 1 1	2/1/2024
Floriva	BonGeo Pharmaceuticals, Inc.	52796-177	ORAL	1000 [iU] in 1 1	2/1/2024
Vitafol Ultra	Exeltis USA, Inc.	0642-0093	ORAL	330 ug in 1 1	3/14/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
MaxN-Fuze Multivitamins	288444	Max Health & Living Australia Pty Ltd	Medicine	A	5/1/2017
Men's Multi	326959	Good Health Products Australia	Medicine	A	12/2/2019
Orthoplex Ultra Buffered C Powder	317425	Bio Concepts Pty Ltd	Medicine	A	5/10/2019
HKSG Swisse Kids Multi	321304	Swisse Wellness Pty Ltd	Medicine	A	8/5/2019
NUTRA-LIFE BILBERRY 10,000 PLUS	310442	Vitaco Health Australia Pty Ltd	Medicine	A	10/17/2018
InNatal	346421	FIT-BioCeuticals Pty Ltd	Medicine	A	10/22/2020
Swisse Ultivite Children's Multivitamin	276713	Swisse Wellness Pty Ltd	Medicine	A	6/17/2016
USANA HealthPak	350153	Usana Australia Pty Ltd	Medicine	A	11/30/2020
Swisse Men's Multivitamins	351919	Swisse Wellness Pty Ltd	Medicine	A	12/18/2020
Daily Multi Multivitamin	337216	Jamieson Health Products Australia Pty Ltd	Medicine	A	5/29/2020

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
CENTURY PLUS	vita health products inc	N/A	Tablet - Oral	3000 UNIT / TAB	2/5/1998
MATERNITY ONE MULTIVITAMIN WITH MINS CAPLET	swiss herbal remedies ltd.	01918052	Tablet - Oral	10000 UNIT	12/31/1991
PRENATAL VITAMINS AND MINERALS TABLETS	pharmetics (2011) inc	02244374	Tablet - Oral	1500 UNIT	10/26/2001
29 ESSENTIAL VITAMINS AND MINERALS	vita health products inc	02231518	Tablet - Oral	3000 UNIT	1/13/1998
29 ESSENTIAL VITAMINS AND MINERALS (FOR PEOPLE 50+)	vita health products inc	02231519	Tablet - Oral	3000 UNIT	1/13/1998
ACES CAPLET	nu-life nutrition ltd.	02060736	Tablet - Oral	15000 UNIT	8/15/1997
29 MULTIVITAMINS + MINERALS - TAB	stanley pharmaceuticals, a division of vita health products inc.	02217775	Tablet - Oral	2000 UNIT	10/18/1996
VITAMINS C PLUS E W.BETA CAROTENE AND SE	pharmetics (2011) inc	02208415	Tablet - Oral	5000 UNIT	1/6/1997
ONE A DAY ADVANCE FEM	bayer inc consumer care	02239342	Tablet - Oral	1050 UNIT / TAB	3/1/1999
ONE PER DAY OMNIPLEX WITH BETA CAROTENE-TAB	vita health products inc	02135795	Tablet - Oral	10000 UNIT	10/11/1996

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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