NDC Code(s) : 18860-852-00, 18860-852-01
Packager : Azur Pharma, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Natelle One Natelle One CAPSULE, GELATIN COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:18860-852
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCONEXENT(UNII: ZAD9OKH9JC)
(DOCONEXENT - UNII:ZAD9OKH9JC) 		DOCONEXENT250 mg
ICOSAPENT(UNII: AAN7QOV9EA)
(ICOSAPENT - UNII:AAN7QOV9EA) 		ICOSAPENT0.625 mg
TRICALCIUM PHOSPHATE(UNII: K4C08XP666)
(CALCIUM - UNII:SY7Q814VUP) 		TRICALCIUM PHOSPHATE100 mg
FERROUS FUMARATE(UNII: R5L488RY0Q)
(IRON - UNII:E1UOL152H7) 		FERROUS FUMARATE27 mg
ASCORBIC ACID(UNII: PQ6CK8PD0R)
(ASCORBIC ACID - UNII:PQ6CK8PD0R) 		ASCORBIC ACID30 mg
PYRIDOXINE HYDROCHLORIDE(UNII: 68Y4CF58BV)
(PYRIDOXINE - UNII:KV2JZ1BI6Z) 		PYRIDOXINE HYDROCHLORIDE25 mg
ALPHA-TOCOPHEROL, D-(UNII: N9PR3490H9)
(ALPHA-TOCOPHEROL, D- - UNII:N9PR3490H9) 		ALPHA-TOCOPHEROL, D-30 [iU]
FOLIC ACID(UNII: 935E97BOY8)
(FOLIC ACID - UNII:935E97BOY8) 		FOLIC ACID1 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN(UNII: 2G86QN327L)
GLYCERIN(UNII: PDC6A3C0OX)
WAX, YELLOW(UNII: 2ZA36H0S2V)
HYDROGENATED SOYBEAN OIL(UNII: A2M91M918C)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
ETHYL VANILLIN(UNII: YC9ST449YJ)
Product Characteristics
Color red Score no score
Shape CAPSULE (oblong) Size 25 mm
Flavor Imprint Code Natelle;1
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:18860-852-005 in 1 BLISTER PACK
2NDC:18860-852-0130 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other na 11/09/2009

PRINCIPAL DISPLAY PANEL

ID="inv-4b10cddc-c5f8-4fe9-90d2-9ce06c7dcbb9"> Natelle One Bottle Label

PRINCIPAL DISPLAY PANEL

ID="inv-425f0e5d-d8de-43f2-8447-1c273afdedb5"> Natelle One Starter Kit Label