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  5. NDC Package Code: 75854-308-30 Prenate Restore

NDC Package 75854-308-30 Prenate Restore

Ascorbic Acid,Cholecalciferol,.alpha.-tocopherol Acetate,Dl-,Folic Acid,Pyridoxine - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
75854-308-30
Package Description:
30 CAPSULE, GELATIN COATED in 1 BOTTLE
Product Code:
75854-308
Proprietary Name:
Prenate Restore
Non-Proprietary Name:
Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Folic Acid, Pyridoxine Hydrochloride, Cyanocobalamin, Biotin, Calcium Carbonate, Ferrous Fumarate, Magnesium Oxide, Lactic Acid And Doconexent
Substance Name:
.alpha.-tocopherol Acetate, Dl-; Ascorbic Acid; Biotin; Calcium Carbonate; Cholecalciferol; Cyanocobalamin; Doconexent; Ferrous Fumarate; Folic Acid; Lactic Acid; Magnesium Oxide; Pyridoxine Hydrochloride
Usage Information:
INDICATIONS: PRENATE ® Restore is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women during the postnatal period for both lactating and non-lactating mothers.
11-Digit NDC Billing Format:
75854030830
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
30 EA
Product Type:
Human Prescription Drug
Labeler Name:
Avion Pharmaceuticals, Llc
Dosage Form:
Capsule, Gelatin Coated - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal.
Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • .ALPHA.-TOCOPHEROL ACETATE, DL- 10 [iU]/1
  • ASCORBIC ACID 85 mg/1
  • BIOTIN 500 ug/1
  • CALCIUM CARBONATE 155 mg/1
  • CHOLECALCIFEROL 1000 [iU]/1
  • CYANOCOBALAMIN 12 ug/1
  • DOCONEXENT 400 mg/1
  • FERROUS FUMARATE 27 mg/1
  • FOLIC ACID 1 mg/1
  • LACTIC ACID 10 mg/1
  • MAGNESIUM OXIDE 45 mg/1
  • PYRIDOXINE HYDROCHLORIDE 25 mg/1
    • Pharmacologic Class(es):
  • Acidifying Activity - [MoA] (Mechanism of Action)
  • Analogs/Derivatives - [Chemical/Ingredient]
  • Ascorbic Acid - [CS]
  • Blood Coagulation Factor - [EPC] (Established Pharmacologic Class)
  • Calcium - [CS]
  • Calculi Dissolution Agent - [EPC] (Established Pharmacologic Class)
  • Cations, Divalent - [CS]
  • Increased Coagulation Factor Activity - [PE] (Physiologic Effect)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Inhibition Small Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Magnesium Ion Exchange Activity - [MoA] (Mechanism of Action)
  • Osmotic Activity - [MoA] (Mechanism of Action)
  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Phosphate Binder - [EPC] (Established Pharmacologic Class)
  • Phosphate Chelating Activity - [MoA] (Mechanism of Action)
  • Stimulation Large Intestine Fluid/Electrolyte Secretion - [PE] (Physiologic Effect)
  • Vitamin B 12 - [CS]
  • Vitamin B 6 - [Chemical/Ingredient]
  • Vitamin B12 - [EPC] (Established Pharmacologic Class)
  • Vitamin B6 Analog - [EPC] (Established Pharmacologic Class)
  • Vitamin C - [EPC] (Established Pharmacologic Class)
  • Vitamin D - [CS]
  • Vitamin D - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    Marketing Category:
    UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
    Start Marketing Date:
    09-17-2013
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 75854-308-30?

    The NDC Packaged Code 75854-308-30 is assigned to a package of 30 capsule, gelatin coated in 1 bottle of Prenate Restore, a human prescription drug labeled by Avion Pharmaceuticals, Llc. The product's dosage form is capsule, gelatin coated and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package.

    Is NDC 75854-308 included in the NDC Directory?

    Yes, Prenate Restore with product code 75854-308 is active and included in the NDC Directory. The product was first marketed by Avion Pharmaceuticals, Llc on September 17, 2013 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 75854-308-30?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 30.

    What is the 11-digit format for NDC 75854-308-30?

    The 11-digit format is 75854030830. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-275854-308-305-4-275854-0308-30