NDC Code(s) : 68788-6779-1
Packager : Preferred Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Prenatal PlusVitamin A, Ascorbic Acid, Cholecalciferol, .Alpha.-Tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Iron, Zinc Oxide, and Cupric Oxide TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-6779(NDC:42937-705)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Vitamin A(UNII: 81G40H8B0T)
(Vitamin A - UNII:81G40H8B0T) 		Vitamin A4000 [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 [iU]
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)
(Carbonate Ion - UNII:7UJQ5OPE7D) 		Calcium Carbonate200 mg
Iron(UNII: E1UOL152H7)
(Iron - UNII:E1UOL152H7) 		Iron29 mg
Zinc Oxide(UNII: SOI2LOH54Z)
(Zinc Oxide - UNII:SOI2LOH54Z) 		Zinc Oxide25 mg
Cupric Oxide(UNII: V1XJQ704R4)
(Cupric Cation - UNII:8CBV67279L) 		Cupric Cation2 mg
Inactive Ingredients
Ingredient Name Strength
Ascorbyl Palmitate(UNII: QN83US2B0N)
Anhydrous Citric Acid(UNII: XF417D3PSL)
.Alpha.-Tocopherol, Dl-(UNII: 7QWA1RIO01)
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
FD&C Blue No. 2(UNII: L06K8R7DQK)
Aluminum Oxide(UNII: LMI26O6933)
FD&C Red No. 40(UNII: WZB9127XOA)
FD&C Yellow No. 5(UNII: I753WB2F1M)
FD&C Yellow No. 6(UNII: H77VEI93A8)
DEXTROSE, UNSPECIFIED FORM(UNII: IY9XDZ35W2)
Acacia(UNII: 5C5403N26O)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
Magnesium Stearate(UNII: 70097M6I30)
Starch, Corn(UNII: O8232NY3SJ)
Maltodextrin(UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
Mineral Oil(UNII: T5L8T28FGP)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
Silicon Dioxide(UNII: ETJ7Z6XBU4)
Sorbic Acid(UNII: X045WJ989B)
Soy Protein(UNII: R44IWB3RN5)
Stearic Acid(UNII: 4ELV7Z65AP)
Sucrose(UNII: C151H8M554)
Titanium Dioxide(UNII: 15FIX9V2JP)
Tricalcium Phosphate(UNII: K4C08XP666)
Product Characteristics
Color YELLOW (Tan) Score no score
Shape OVAL Size 18 mm
Flavor Imprint Code CIS;28
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68788-6779-1100 in 1 BOTTLE Type 0: Not a Combination Product25/10/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 10/25/2016

PRINCIPAL DISPLAY PANEL

Nationwide Laboratories LLC

NDC 68788-6779-1

Prenatal Plus
Iron Tablets

Multivitamin/Multimineral
Supplement

For Use Before, During
and After Pregnancy.

Rx only

100 Tablets

Relabeled By: Preferred Pharmaceuticals, Inc.

Prenatal Plus Iron Tablets