Prenatal plus tablet, film coated

Ingredients and appearance - Product information

Prenatal plus tablet, film coated- Vitamin a acetate, .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide, cupric oxide

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 65162-668
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Vitamin a acetate ( UNII: 3LE3D9D6OY)( Vitamin a - UNII: 81G40H8B0T ) 3080 [iU]in 1
.beta.-carotene ( UNII: 01YAE03M7J)( .beta.-carotene - UNII: 01YAE03M7J ) 920 [iU]in 1
Ascorbic acid ( UNII: PQ6CK8PD0R)( Ascorbic acid - UNII: PQ6CK8PD0R ) 120 mgin 1
Cholecalciferol ( UNII: 1C6V77QF41)( Cholecalciferol - UNII: 1C6V77QF41 ) 400 [iU]in 1
.alpha.-tocopherol acetate, dl- ( UNII: WR1WPI7EW8)( .alpha.-tocopherol, dl- - UNII: 7QWA1RIO01 ) 22 mgin 1
Thiamine mononitrate ( UNII: 8K0I04919X)( Thiamine ion - UNII: 4ABT0J945J ) 1.84 mgin 1
Riboflavin ( UNII: TLM2976OFR)( Riboflavin - UNII: TLM2976OFR ) 3 mgin 1
Niacinamide ( UNII: 25X51I8RD4)( Niacinamide - UNII: 25X51I8RD4 ) 20 mgin 1
Pyridoxine hydrochloride ( UNII: 68Y4CF58BV)( Pyridoxine - UNII: KV2JZ1BI6Z ) 10 mgin 1
Folic acid ( UNII: 935E97BOY8)( Folic acid - UNII: 935E97BOY8 ) 1 mgin 1
Cyanocobalamin ( UNII: P6YC3EG204)( Cyanocobalamin - UNII: P6YC3EG204 ) 12 ugin 1
Calcium carbonate ( UNII: H0G9379FGK)( Calcium cation - UNII: 2M83C4R6ZB ) 200 mgin 1
Ferrous fumarate ( UNII: R5L488RY0Q)( Ferrous cation - UNII: GW89581OWR ) 27 mgin 1
Zinc oxide ( UNII: SOI2LOH54Z)( Zinc oxide - UNII: SOI2LOH54Z ) 25 mgin 1
Cupric oxide ( UNII: V1XJQ704R4)( Cupric cation - UNII: 8CBV67279L ) 2 mgin 1

Inactive Ingredients

Ingredient Name Code
Ascorbyl palmitate ( UNII: QN83US2B0N)
Butylated hydroxytoluene ( UNII: 1P9D0Z171K)
Croscarmellose sodium ( UNII: M28OL1HH48)
Calcium phosphate, dibasic, dihydrate ( UNII: O7TSZ97GEP)
.alpha.-tocopherol, dl- ( UNII: 7QWA1RIO01)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Fd&c yellow no. 5 ( UNII: I753WB2F1M)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)
Gelatin ( UNII: 2G86QN327L)
Hypromelloses ( UNII: 3NXW29V3WO)
Magnesium stearate ( UNII: 70097M6I30)
Maltodextrin ( UNII: 7CVR7L4A2D)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Polyethylene glycols ( UNII: 3WJQ0SDW1A)
Propylene glycol ( UNII: 6DC9Q167V3)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Sodium ascorbate ( UNII: S033EH8359)
Sodium benzoate ( UNII: OJ245FE5EU)
Sorbic acid ( UNII: X045WJ989B)
Starch, corn ( UNII: O8232NY3SJ)
Stearic acid ( UNII: 4ELV7Z65AP)
Sucrose ( UNII: C151H8M554)
Sunflower oil ( UNII: 3W1JG795YI)
Titanium dioxide ( UNII: 15FIX9V2JP)
Triacetin ( UNII: XHX3C3X673)

Product Characteristics

Color YELLOW Imprint Code G12
Score 1 Shape OVAL
Size 19 mm

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
UNAPPROVED DRUG OTHER USA

Labeler - Amneal Pharmaceuticals, LLC( 123797875)

Establishment

Name ID/FEI Business Operations
Amneal Pharmaceuticals, LLC 123797875 ANALYSIS( 65162-668), MANUFACTURE( 65162-668)