NDC 75854-308

PRENATE Restore

Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Folic Acid, Pyridoxine Hydrochloride, Cyanocobalamin, Biotin, Calcium Carbonate, Ferrous Fumarate, Magnesium Oxide, Lactic Acid And Doconexent

PRENATE Restore is a Oral Capsule, Gelatin Coated in the Human Prescription Drug category. It is labeled and distributed by Avion Pharmaceuticals, Llc. The primary component is Ascorbic Acid; Cholecalciferol; .alpha.-tocopherol Acetate, Dl-; Folic Acid; Pyridoxine Hydrochloride; Cyanocobalamin; Biotin; Calcium Carbonate; Ferrous Fumarate; Magnesium Oxide; Lactic Acid; Doconexent.

• Product ID: 75854-308_620b81eb-87d6-7acd-e053-2991aa0ac6e8
• NDC: 75854-308
• Product Type: Human Prescription Drug
• Proprietary Name: PRENATE Restore
• Generic Name: Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Folic Acid, Pyridoxine Hydrochloride, Cyanocobalamin, Biotin, Calcium Carbonate, Ferrous Fumarate, Magnesium Oxide, Lactic Acid And Doconexent
• Dosage Form: Capsule, Gelatin Coated
• Route of Administration: ORAL
• Marketing Start Date: 2013-09-17
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Avion Pharmaceuticals, LLC
• Substance Name: ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; FOLIC ACID; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; BIOTIN; CALCIUM CARBONATE; FERROUS FUMARATE; MAGNESIUM OXIDE; LACTIC ACID; DOCONEXENT
• Active Ingredient Strength: 85 mg/1; [iU]/1; [iU]/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1
• Pharm Classes: Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],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 75854-308-30

30 CAPSULE, GELATIN COATED in 1 BOTTLE (75854-308-30)

• Marketing Start Date: 2013-09-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 75854-308-30 [75854030830]

PRENATE Restore CAPSULE, GELATIN COATED

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-09-17

Drug Details

Active Ingredients

Ingredient	Strength
ASCORBIC ACID	85 mg/1

OpenFDA Data

• SPL SET ID: 1076ba9a-0168-492f-ba9b-99fa02186092
• Manufacturer:
  • Avion Pharmaceuticals, LLC
• UNII:
  • 3A3U0GI71G
  • ZAD9OKH9JC
  • 68Y4CF58BV
  • WR1WPI7EW8
  • PQ6CK8PD0R
  • 1C6V77QF41
  • R5L488RY0Q
  • 33X04XA5AT
  • 935E97BOY8
  • H0G9379FGK
  • 6SO6U10H04
  • P6YC3EG204

Pharmacological Class

• Vitamin C [EPC]
• Ascorbic Acid [CS]
• Vitamin D [CS]
• Vitamin D [EPC]
• Vitamin B6 Analog [EPC]
• Vitamin B 6 [Chemical/Ingredient]
• Analogs/Derivatives [Chemical/Ingredient]
• Vitamin B 12 [CS]
• Vitamin B12 [EPC]
• Blood Coagulation Factor [EPC]
• Increased Coagulation Factor Activity [PE]
• Calcium [CS]
• Cations
• Divalent [CS]
• 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 Crossover Matching brand name "PRENATE Restore" or generic name "Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Folic Acid, Pyridoxine Hydrochloride, Cyanocobalamin, Biotin, Calcium Carbonate, Ferrous Fumarate, Magnesium Oxide, Lactic Acid And Doconexent"

NDC	Brand Name	Generic Name
75854-308	PRENATE Restore	ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, magnesium oxide, lactic acid and doconexent
75854-309	PRENATE Enhance	ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, magnesium oxide, lactic acid and doconexent