NDC Code(s) : 13925-509-10, 13925-509-50
Packager : Seton Pharmaceuticals LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Prenatal Plus.beta.-carotene, sodium acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide and cupric oxide TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13925-509
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.-CAROTENE2000 [iU]
SODIUM ACETATE(UNII: 4550K0SC9B)
(ACETATE ION - UNII:569DQM74SC) 		ACETATE ION2000 [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, DL- - UNII:7QWA1RIO01) 		.ALPHA.-TOCOPHEROL, DL-22 mg
THIAMINE MONONITRATE(UNII: 8K0I04919X)
(THIAMINE ION - UNII:4ABT0J945J) 		THIAMINE ION1.84 mg
RIBOFLAVIN(UNII: TLM2976OFR)
(RIBOFLAVIN - UNII:TLM2976OFR) 		RIBOFLAVIN3 mg
NIACINAMIDE(UNII: 25X51I8RD4)
(NIACINAMIDE - UNII:25X51I8RD4) 		NIACINAMIDE20 mg
PYRIDOXINE HYDROCHLORIDE(UNII: 68Y4CF58BV)
(PYRIDOXINE - UNII:KV2JZ1BI6Z) 		PYRIDOXINE HYDROCHLORIDE10 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
FERROUS FUMARATE(UNII: R5L488RY0Q)
(FERROUS CATION - UNII:GW89581OWR) 		FERROUS CATION27 mg
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC CATION - UNII:13S1S8SF37) 		ZINC CATION25 mg
CUPRIC OXIDE(UNII: V1XJQ704R4)
(CUPRIC CATION - UNII:8CBV67279L) 		CUPRIC CATION2 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYVINYL ALCOHOL(UNII: 532B59J990)
SILICON(UNII: Z4152N8IUI)
STARCH, CORN(UNII: O8232NY3SJ)
STEARIC ACID(UNII: 4ELV7Z65AP)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color YELLOW Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code G12
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13925-509-10100 in 1 BOTTLE
2NDC:13925-509-50500 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/07/2014

PRINCIPAL DISPLAY PANEL

NDC 13925-509-10

Prenatal
Plus

Vitamin and Mineral
Tablet

Multi-
Vitamin

Rx Only

100 Tablets

SETON
PHARMACEUTICALS

PRINCIPAL DISPLAY PANEL - 100 tablets