65162-668 NDC - PRENATAL PLUS (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)

Drug Information

Product NDC: 65162-668

Proprietary Name: PRENATAL PLUS

Non Proprietary Name: 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

Active Ingredient(s):
  • 22 mg/1 .ALPHA.-TOCOPHEROL ACETATE, DL-;
  • 920 [iU]/1 .BETA.-CAROTENE;
  • 120 mg/1 ASCORBIC ACID;
  • 200 mg/1 CALCIUM CARBONATE;
  • 400 [iU]/1 CHOLECALCIFEROL;
  • 2 mg/1 CUPRIC OXIDE;
  • 12 ug/1 CYANOCOBALAMIN;
  • 27 mg/1 FERROUS FUMARATE;
  • 1 mg/1 FOLIC ACID;
  • 20 mg/1 NIACINAMIDE;
  • 10 mg/1 PYRIDOXINE HYDROCHLORIDE;
  • 3 mg/1 RIBOFLAVIN;
  • 1.84 mg/1 THIAMINE MONONITRATE;
  • 3080 [iU]/1 VITAMIN A ACETATE;
  • 25 mg/1 ZINC OXIDE


Administration Route(s): ORAL

Dosage Form(s): TABLET, FILM COATED

Pharmacy Class(es):
  • Vitamin A [Chemical/Ingredient];
  • Vitamin A [EPC];
  • Vitamin D [Chemical/Ingredient];
  • Vitamin D [EPC];
  • Vitamin B 12 [Chemical/Ingredient];
  • Vitamin B12 [EPC];
  • Blood Coagulation Factor [EPC];
  • Increased Coagulation Factor Activity [PE];
  • Calcium [Chemical/Ingredient];
  • Cations;
  • Divalent [Chemical/Ingredient]

Labeler Information

Labeler Name: Amneal Pharmaceuticals, LLC
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number:
Marketing Category: UNAPPROVED DRUG OTHER
Start Marketing Date:12/2/2009

Package Information

No. Package Code Package Description
1 65162-668-10 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (65162-668-10)
2 65162-668-50 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (65162-668-50)

NDC Record

No. Field Name Field Value
1 PRODUCT NDC 65162-668
2 PRODUCT TYPE NAME HUMAN PRESCRIPTION DRUG
3 PROPRIETARY NAME PRENATAL PLUS
4 NON PROPRIETARY NAME 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
5 DOSAGE FORM NAME TABLET, FILM COATED
6 ROUTE NAME ORAL
7 START MARKETING DATE 12/2/2009
8 MARKETING CATEGORY NAME UNAPPROVED DRUG OTHER
9 LABELER NAME Amneal Pharmaceuticals, LLC
10 SUBSTANCE NAME .ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; ASCORBIC ACID; CALCIUM CARBONATE; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A ACETATE; ZINC OXIDE
11 ACTIVE NUMERATOR STRENGTH 22; 920; 120; 200; 400; 2; 12; 27; 1; 20; 10; 3; 1.84; 3080; 25
12 ACTIVE INGRED UNIT mg/1; [iU]/1; mg/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1
13 PHARM CLASSES Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient]

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This page was last updated on: 3/14/2014