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 Field Definition
1 PRODUCT NDC 65162-668 The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
2 PRODUCT TYPE NAME HUMAN PRESCRIPTION DRUG Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
3 PROPRIETARY NAME PRENATAL PLUS Also known as the trade name. It is the name of the product chosen by the labeler.
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 Sometimes called the generic name, this is usually the active ingredient(s) of the product.
5 DOSAGE FORM NAME TABLET, FILM COATED The translation of the DosageForm Code submitted by the firm.
6 ROUTE NAME ORAL The translation of the Route Code submitted by the firm, indicating route of administration.
7 START MARKETING DATE 12/2/2009 This is the date that the labeler indicates was the start of its marketing of the drug product.
8 MARKETING CATEGORY NAME UNAPPROVED DRUG OTHER Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
9 LABELER NAME Amneal Pharmaceuticals, LLC Name of Company corresponding to the labeler code segment of the Product NDC.
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 This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
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: 4/21/2015