NDC 58154-107

healthy mamaBE WELL ROUNDED BE WELL ROUNDED

.beta.-carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine, Riboflavin, Niacin, Pyridoxine Hydrochloride, Folic Acid, Methylcobalamin, Calcium Carbonate, Ferrous Bisglycinate, Zinc Oxide, Copper, Calcium Pantothenate,magnesium Oxide

healthy mamaBE WELL ROUNDED BE WELL ROUNDED is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Maternal Science, Llc. The primary component is .beta.-carotene; Ascorbic Acid; Cholecalciferol; .alpha.-tocopherol Acetate, Dl-; Thiamine; Riboflavin; Niacin; Pyridoxine Hydrochloride; Folic Acid; Methylcobalamin; Calcium Carbonate; Ferrous Bisglycinate; Zinc Oxide; Copper; Biotin; Calcium Pantothenate; Magnesium Oxide.

Product ID58154-107_88b9de99-b1a3-41ae-b06c-65c819fa94bb
NDC58154-107
Product TypeHuman Prescription Drug
Proprietary Namehealthy mamaBE WELL ROUNDED BE WELL ROUNDED
Generic Name.beta.-carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine, Riboflavin, Niacin, Pyridoxine Hydrochloride, Folic Acid, Methylcobalamin, Calcium Carbonate, Ferrous Bisglycinate, Zinc Oxide, Copper, Calcium Pantothenate,magnesium Oxide
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2013-07-09
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameMATERNAL SCIENCE, LLC
Substance Name.BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE; RIBOFLAVIN; NIACIN; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; METHYLCOBALAMIN; CALCIUM CARBONATE; FERROUS BISGLYCINATE; ZINC OXIDE; COPPER; BIOTIN; CALCIUM PANTOTHENATE; MAGNESIUM OXIDE
Active Ingredient Strength4000 [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1
Pharm ClassesVitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 58154-107-60

60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58154-107-60)
Marketing Start Date2013-07-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58154-107-60 [58154010760]

healthy mamaBE WELL ROUNDED BE WELL ROUNDED TABLET, FILM COATED
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-07-09
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
.BETA.-CAROTENE4000 [iU]/1

OpenFDA Data

SPL SET ID:b0addefd-148c-423b-bcff-332c255a2d90
Manufacturer
UNII

Pharmacological Class

  • Vitamin C [EPC]
  • Ascorbic Acid [CS]
  • Vitamin D [CS]
  • Vitamin D [EPC]
  • Nicotinic Acid [EPC]
  • Nicotinic Acids [CS]
  • Vitamin B6 Analog [EPC]
  • Vitamin B 6 [Chemical/Ingredient]
  • Analogs/Derivatives [Chemical/Ingredient]
  • Blood Coagulation Factor [EPC]
  • Increased Coagulation Factor Activity [PE]
  • Calcium [CS]
  • Cations
  • Divalent [CS]
  • Copper Absorption Inhibitor [EPC]
  • Decreased Copper Ion Absorption [PE]
  • Copper [CS]
  • Copper-containing Intrauterine Device [EPC]
  • Decreased Embryonic Implantation [PE]
  • Decreased Sperm Motility [PE]
  • Inhibit Ovum Fertilization [PE]
  • Calculi Dissolution Agent [EPC]
  • Magnesium Ion Exchange Activity [MoA]
  • Osmotic Laxative [EPC]
  • Osmotic Activity [MoA]
  • Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]
  • Increased Large Intestinal Motility [PE]
  • Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
  • Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]

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