NDC Code(s) : 64376-813-01
Packager : Boca Pharmacal, Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Multi-Vitamin With Fluoride Vitamin A, Vitamin D, Thiamine, Riboflavin, Niacin, Pyridoxine, Folic Acid, Fluoride Ion, Ascorbic Acid, .Alpha.-Tocopherol-Acetate-DL, Cyanocobalamin TABLET, CHEWABLE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64376-813
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 A2500 [iU]
VITAMIN D(UNII: 9VU1KI44GP)
(VITAMIN D - UNII:9VU1KI44GP) 		VITAMIN D400 [iU]
THIAMINE(UNII: X66NSO3N35)
(THIAMINE - UNII:X66NSO3N35) 		THIAMINE1.05 mg
RIBOFLAVIN(UNII: TLM2976OFR)
(RIBOFLAVIN - UNII:TLM2976OFR) 		RIBOFLAVIN1.2 mg
NIACIN(UNII: 2679MF687A)
(NIACIN - UNII:2679MF687A) 		NIACIN13.5 mg
PYRIDOXINE(UNII: KV2JZ1BI6Z)
(PYRIDOXINE - UNII:KV2JZ1BI6Z) 		PYRIDOXINE1.05 mg
FOLIC ACID(UNII: 935E97BOY8)
(FOLIC ACID - UNII:935E97BOY8) 		FOLIC ACID0.3 mg
FLUORIDE ION(UNII: Q80VPU408O)
(FLUORIDE ION - UNII:Q80VPU408O) 		FLUORIDE ION0.25 mg
ASCORBIC ACID(UNII: PQ6CK8PD0R)
(ASCORBIC ACID - UNII:PQ6CK8PD0R) 		ASCORBIC ACID60 mg
.ALPHA.-TOCOPHEROL ACETATE, DL-(UNII: WR1WPI7EW8)
(.ALPHA.-TOCOPHEROL ACETATE, DL- - UNII:WR1WPI7EW8) 		.ALPHA.-TOCOPHEROL ACETATE, DL-15 [iU]
CYANOCOBALAMIN(UNII: P6YC3EG204)
(CYANOCOBALAMIN - UNII:P6YC3EG204) 		CYANOCOBALAMIN4.5 ug
Inactive Ingredients
Ingredient Name Strength
MALTODEXTRIN(UNII: 7CVR7L4A2D)
CHOLECALCIFEROL(UNII: 1C6V77QF41)
CYANOCOBALAMIN(UNII: P6YC3EG204)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
FOLIC ACID(UNII: 935E97BOY8)
GELATIN(UNII: 2G86QN327L)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
NIACINAMIDE(UNII: 25X51I8RD4)
POVIDONE(UNII: FZ989GH94E)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
.ALPHA.-TOCOPHEROL, DL-(UNII: 7QWA1RIO01)
RIBOFLAVIN(UNII: TLM2976OFR)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
THIAMINE(UNII: X66NSO3N35)
VITAMIN A ACETATE(UNII: 3LE3D9D6OY)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
SUCROSE(UNII: C151H8M554)
PYRIDOXINE(UNII: KV2JZ1BI6Z)
SODIUM ASCORBATE(UNII: S033EH8359)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
STARCH, CORN(UNII: O8232NY3SJ)
SUCRALOSE(UNII: 96K6UQ3ZD4)
ORANGE(UNII: 5EVU04N5QU)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
Product Characteristics
Color ORANGE Score no score
Shape ROUND (Flat) Size 13 mm
Flavor ORANGE Imprint Code BP;813
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:64376-813-01100 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 12/28/2011

PRINCIPAL DISPLAY PANEL

7a84138c-figure-01

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