NDC Code(s) : 75854-303-30
Packager : Avion Pharmaceuticals, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

prenate essential- ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, doconexent and icosapent TABLET, COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:75854-303
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID(UNII: PQ6CK8PD0R)
(ASCORBIC ACID - UNII:PQ6CK8PD0R) 		ASCORBIC ACID90 mg
CHOLECALCIFEROL(UNII: 1C6V77QF41)
(CHOLECALCIFEROL - UNII:1C6V77QF41) 		CHOLECALCIFEROL220 [iU]
.ALPHA.-TOCOPHEROL, DL-(UNII: 7QWA1RIO01)
(.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) 		.ALPHA.-TOCOPHEROL, DL-10 [iU]
PYRIDOXINE HYDROCHLORIDE(UNII: 68Y4CF58BV)
(PYRIDOXINE - UNII:KV2JZ1BI6Z) 		PYRIDOXINE HYDROCHLORIDE26 mg
FOLIC ACID(UNII: 935E97BOY8)
(FOLIC ACID - UNII:935E97BOY8) 		FOLIC ACID1 mg
CYANOCOBALAMIN(UNII: P6YC3EG204)
(CYANOCOBALAMIN - UNII:P6YC3EG204) 		CYANOCOBALAMIN13 ug
BIOTIN(UNII: 6SO6U10H04)
(BIOTIN - UNII:6SO6U10H04) 		BIOTIN280 ug
CALCIUM CARBONATE(UNII: H0G9379FGK)
(CALCIUM CATION - UNII:2M83C4R6ZB) 		CALCIUM CATION145 mg
FERROUS FUMARATE(UNII: R5L488RY0Q)
(FERROUS CATION - UNII:GW89581OWR) 		FERROUS CATION29 mg
POTASSIUM IODIDE(UNII: 1C4QK22F9J)
(IODIDE ION - UNII:09G4I6V86Q) 		POTASSIUM IODIDE150 ug
MAGNESIUM OXIDE(UNII: 3A3U0GI71G)
(MAGNESIUM CATION - UNII:T6V3LHY838) 		MAGNESIUM OXIDE50 mg
DOCONEXENT(UNII: ZAD9OKH9JC)
(DOCONEXENT - UNII:ZAD9OKH9JC) 		DOCONEXENT300 mg
ICOSAPENT(UNII: AAN7QOV9EA)
(ICOSAPENT - UNII:AAN7QOV9EA) 		ICOSAPENT40 mg
Inactive Ingredients
Ingredient Name Strength
YELLOW WAX(UNII: 2ZA36H0S2V)
CORN OIL(UNII: 8470G57WFM)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
GELATIN(UNII: 2G86QN327L)
GLYCERIN(UNII: PDC6A3C0OX)
WATER(UNII: 059QF0KO0R)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
Product Characteristics
Color green, yellow (opaque) Score 2 pieces
Shape OVAL Size 24 mm
Flavor Imprint Code Prenate
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:75854-303-3030 in 1 CARTON 12/11/2012
130 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 11/12/2012 09/30/2015

PRINCIPAL DISPLAY PANEL

75854-303-30         30 Softgels

PRENATE ESSENTIAL ®
Rx prenatal vitamin & DHA Essential ®

with
Quatrefolic ®

• Key vitamins, minerals, and DHA support nutrition

Long lasting stability
Improved bioavailability
High water solubility
Established safety

Quatrefolic ®            Rx Only

Prenate DHA is a registered trademark of Acella Pharmaceuticals, LLC.
*Quatrefolic® is a registered trademark of Gnosis, SpA. Covered by one or more claims of U.S. Patent # 7,947,662 CAS# 1181972-37-1
Under license from Acella Pharmaceuticals, LLC.
All rights reserved.

PRINCIPAL DISPLAY PANEL - 30 tablets