NDC 0642-0093

Vitafol Ultra

Doconexent, Niacinamide, .alpha.-tocopherol Acetate, Dl-, Cholecalciferol, .beta.-carotene, Ascorbic Acid, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Iron, Zinc Oxide, Cupric Oxide, Potassium Iodide, Magnesium Oxide, Folic Acid, And Levomefolate Calcium

Vitafol Ultra is a Oral Capsule, Liquid Filled in the Human Prescription Drug category. It is labeled and distributed by Exeltis Usa, Inc.. The primary component is Doconexent; Niacinamide; .alpha.-tocopherol Acetate, Dl-; Cholecalciferol; .beta.-carotene; Ascorbic Acid; Thiamine Mononitrate; Riboflavin; Pyridoxine Hydrochloride; Cyanocobalamin; Iron; Zinc Oxide; Cupric Oxide; Potassium Iodide; Magnesium Oxide; Folic Acid; Levomefolate Calcium.

• Product ID: 0642-0093_042a594f-b2d4-4381-bdcb-ddcb9b34eda0
• NDC: 0642-0093
• Product Type: Human Prescription Drug
• Proprietary Name: Vitafol Ultra
• Generic Name: Doconexent, Niacinamide, .alpha.-tocopherol Acetate, Dl-, Cholecalciferol, .beta.-carotene, Ascorbic Acid, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Iron, Zinc Oxide, Cupric Oxide, Potassium Iodide, Magnesium Oxide, Folic Acid, And Levomefolate Calcium
• Dosage Form: Capsule, Liquid Filled
• Route of Administration: ORAL
• Marketing Start Date: 2013-09-23
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Exeltis USA, Inc.
• Substance Name: DOCONEXENT; NIACINAMIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-; CHOLECALCIFEROL; .BETA.-CAROTENE; ASCORBIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; IRON; ZINC OXIDE; CUPRIC OXIDE; POTASSIUM IODIDE; MAGNESIUM OXIDE; FOLIC ACID; LEVOMEFOLATE CALCIUM
• Active Ingredient Strength: 200 mg/1; mg/1; [iU]/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1
• Pharm Classes: Vitamin D [CS],Vitamin D [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],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 Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0642-0093-03

1 BLISTER PACK in 1 BOX (0642-0093-03) > 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

• Marketing Start Date: 2013-09-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0642-0093-30 [00642009330]

Vitafol Ultra CAPSULE, LIQUID FILLED

• Marketing Category: UNAPPROVED DRUG OTHER
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-09-23

NDC 0642-0093-01 [00642009301]

Vitafol Ultra CAPSULE, LIQUID FILLED

• Marketing Category: UNAPPROVED DRUG OTHER
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-09-23
• Marketing End Date: 2013-09-23

NDC 0642-0093-03 [00642009303]

Vitafol Ultra CAPSULE, LIQUID FILLED

• Marketing Category: UNAPPROVED DRUG OTHER
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-09-23

Drug Details

Active Ingredients

Ingredient	Strength
DOCONEXENT	200 mg/1

OpenFDA Data

• SPL SET ID: 40fa2c3a-f41f-434c-91de-5150a18d3e4b
• Manufacturer:
  • Exeltis USA, Inc.
• UNII:
  • 25X51I8RD4
  • 1C4QK22F9J
  • ZAD9OKH9JC
  • 68Y4CF58BV
  • WR1WPI7EW8
  • 3A3U0GI71G
  • PQ6CK8PD0R
  • A9R10K3F2F
  • E1UOL152H7
  • 1C6V77QF41
  • V1XJQ704R4
  • TLM2976OFR
  • 8K0I04919X
  • SOI2LOH54Z
  • 01YAE03M7J
  • 935E97BOY8
  • P6YC3EG204

Pharmacological Class

• Vitamin D [CS]
• Vitamin D [EPC]
• Vitamin C [EPC]
• Ascorbic Acid [CS]
• Vitamin B6 Analog [EPC]
• Vitamin B 6 [Chemical/Ingredient]
• Analogs/Derivatives [Chemical/Ingredient]
• Vitamin B 12 [CS]
• Vitamin B12 [EPC]
• 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]