NDC Code(s) : 13811-529-90
Packager : TRIGEN Laboratories, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

TriAdvanceBeta Carotene, Ascorbic Acid, Cholecalciferol, .Alpha.-Tocopherol Acetate, DL-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Iron, Magnesium Oxide, Zinc Oxide, Cupric Oxide, and Docusate Sodium TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13811-529
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Beta Carotene(UNII: 01YAE03M7J)
(Beta Carotene - UNII:01YAE03M7J) 		Beta Carotene2700 [iU]
Ascorbic Acid(UNII: PQ6CK8PD0R)
(Ascorbic Acid - UNII:PQ6CK8PD0R) 		Ascorbic Acid120 mg
Cholecalciferol(UNII: 1C6V77QF41)
(Cholecalciferol - UNII:1C6V77QF41) 		Cholecalciferol400 [iU]
.Alpha.-Tocopherol Acetate, DL-(UNII: WR1WPI7EW8)
(.Alpha.-Tocopherol Acetate, DL- - UNII:WR1WPI7EW8) 		.Alpha.-Tocopherol Acetate, DL-30 [iU]
Thiamine Mononitrate(UNII: 8K0I04919X)
(Thiamine - UNII:X66NSO3N35) 		Thiamine Mononitrate3 mg
Riboflavin(UNII: TLM2976OFR)
(Riboflavin - UNII:TLM2976OFR) 		Riboflavin3.4 mg
Niacinamide(UNII: 25X51I8RD4)
(Niacinamide - UNII:25X51I8RD4) 		Niacinamide20 mg
Pyridoxine Hydrochloride(UNII: 68Y4CF58BV)
(Pyridoxine - UNII:KV2JZ1BI6Z) 		Pyridoxine Hydrochloride20 mg
Folic Acid(UNII: 935E97BOY8)
(Folic Acid - UNII:935E97BOY8) 		Folic Acid1 mg
Cyanocobalamin(UNII: P6YC3EG204)
(Cyanocobalamin - UNII:P6YC3EG204) 		Cyanocobalamin12 ug
Calcium Carbonate(UNII: H0G9379FGK)
(Calcium Cation - UNII:2M83C4R6ZB) 		Calcium Carbonate200 mg
Iron(UNII: E1UOL152H7)
(Iron - UNII:E1UOL152H7) 		Iron90 mg
Magnesium Oxide(UNII: 3A3U0GI71G)
(Magnesium Oxide - UNII:3A3U0GI71G) 		Magnesium Oxide30 mg
Zinc Oxide(UNII: SOI2LOH54Z)
(Zinc Oxide - UNII:SOI2LOH54Z) 		Zinc Oxide25 mg
Cupric Oxide(UNII: V1XJQ704R4)
(Cupric Cation - UNII:8CBV67279L) 		Cupric Oxide2 mg
Docusate Sodium(UNII: F05Q2T2JA0)
(Docusate - UNII:M7P27195AG) 		Docusate Sodium50 mg
Inactive Ingredients
Ingredient Name Strength
Cellulose, Microcrystalline(UNII: OP1R32D61U)
Potassium Citrate Anhydrous(UNII: 86R1NVR0HW)
Acacia(UNII: 5C5403N26O)
Silicon Dioxide(UNII: ETJ7Z6XBU4)
Croscarmellose Sodium(UNII: M28OL1HH48)
Citric Acid Monohydrate(UNII: 2968PHW8QP)
Povidone K30(UNII: U725QWY32X)
Carboxymethylcellulose Sodium(UNII: K679OBS311)
Magnesium Stearate(UNII: 70097M6I30)
Stearic Acid(UNII: 4ELV7Z65AP)
Icodextrin(UNII: 2NX48Z0A9G)
Dextrose(UNII: IY9XDZ35W2)
Sodium Citrate(UNII: 1Q73Q2JULR)
Product Characteristics
Color YELLOW (speckled) Score no score
Shape OVAL (caplet) Size 19 mm
Flavor Imprint Code TL020
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13811-529-9090 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 09/10/2010

PRINCIPAL DISPLAY PANEL

NDC 13811-529-90
Rx Only

TriAdvance

Prenatal Vitamin Tablets

90 TABLETS

TRIGEN
LABORATORIES

PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label