Prenate Chewable

Calcium Carbonate, Cholecalciferol, Magnesium Oxide, Boron, Folic Acid, Pyridoxine Hydrochloride, Cyanocobalamin, Biotin And Bilberry

Avion Pharmaceuticals, Llc
Human Prescription Drug
NDC 75854-306

Prenate Chewable also known as Calcium Carbonate, Cholecalciferol, Magnesium Oxide, Boron, Folic Acid, Pyridoxine Hydrochloride, Cyanocobalamin, Biotin And Bilberry is a human prescription drug labeled by 'Avion Pharmaceuticals, Llc'. National Drug Code (NDC) number for Prenate Chewable is 75854-306. This drug is available in dosage form of Tablet, Chewable. The names of the active, medicinal ingredients in Prenate Chewable drug includes Bilberry - 25 mg/1 Biotin - 280 ug/1 Boron - 250 ug/1 Calcium Carbonate - 500 mg/1 Cholecalciferol - 300 [iU]/1 Cyanocobalamin - 125 mg/1 Folic Acid - 1 mg/1 Magnesium Oxide - 50 mg/1 Pyridoxine Hydrochloride - 10 mg/1 . The currest status of Prenate Chewable drug is Active.

Drug Information:

Drug NDC:	75854-306
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.
Proprietary Name:	Prenate Chewable
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	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.
Non Proprietary Name:	Calcium Carbonate, Cholecalciferol, Magnesium Oxide, Boron, Folic Acid, Pyridoxine Hydrochloride, Cyanocobalamin, Biotin And Bilberry
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Avion Pharmaceuticals, Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Tablet, Chewable
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	BILBERRY - 25 mg/1 BIOTIN - 280 ug/1 BORON - 250 ug/1 CALCIUM CARBONATE - 500 mg/1 CHOLECALCIFEROL - 300 [iU]/1 CYANOCOBALAMIN - 125 mg/1 FOLIC ACID - 1 mg/1 MAGNESIUM OXIDE - 50 mg/1 PYRIDOXINE HYDROCHLORIDE - 10 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	UNAPPROVED DRUG OTHER
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	16 Jan, 2013
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	31 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Avion Pharmaceuticals, LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
NUI:	M0022797 N0000175952 M0022794 N0000175951
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	9P2U39H18W 6SO6U10H04 N9E3X5056Q H0G9379FGK 1C6V77QF41 P6YC3EG204 935E97BOY8 3A3U0GI71G 68Y4CF58BV
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:	Vitamin D [EPC] Vitamin B12 [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class CS:	Vitamin D [CS] Vitamin B 12 [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:	Analogs/Derivatives [Chemical/Ingredient] Blood Coagulation Factor [EPC] Calcium [CS] Calculi Dissolution Agent [EPC] Cations Divalent [CS] Increased Coagulation Factor Activity [PE] Increased Large Intestinal Motility [PE] Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] Inhibition Small Intestine Fluid/Electrolyte Absorption [PE] Magnesium Ion Exchange Activity [MoA] Osmotic Activity [MoA] Osmotic Laxative [EPC] Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] Vitamin B 12 [CS] Vitamin B 6 [Chemical/Ingredient] Vitamin B12 [EPC] Vitamin B6 Analog [EPC] Vitamin D [CS] Vitamin D [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
75854-306-30	30 TABLET, CHEWABLE in 1 BOTTLE (75854-306-30)	16 Jan, 2013	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Prenate Chewable

Calcium Carbonate & more..

Tablet, Chewable
Avion Pharmaceuticals, LLC
NDC: 75854-306

Product Elements:

Prenate chewable calcium carbonate, cholecalciferol, magnesium oxide, boron, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin and bilberry fructose acacia magnesium stearate silicon dioxide calcium carbonate calcium cation cholecalciferol cholecalciferol magnesium oxide magnesium cation boron boron folic acid folic acid pyridoxine hydrochloride pyridoxine cyanocobalamin cyanocobalamin biotin biotin bilberry bilberry prenatechew

Indications and Usage:

Indications: prenate chewable Â® is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. prenate chewable â¢ can also be beneficial in improving the nutritional status of women prior to conception.

Dosage and Administration:

Dosage and administration: one tablet daily or as directed by a physician.

Contraindications:

Contraindications: this product is contraindicated in patients with a known hypersensitivity to any of the ingredients. keep this and all medications out of the reach of children.

Adverse Reactions:

Adverse reactions: allergic sensitization has been reported following both oral and parenteral administration of folic acid.

Description:

Description: prenate chewable Â® is a prescription prenatal/postnatal multivitamin/mineral chocolate chewable tablet. each tablet is brown and imprinted with "prenate chew" on one side and blank on the other. supplement

How Supplied:

How supplied: prenate chewable Â® is supplied in child-resistant bottles of 30 tablets (75854-306-30). the listed product number is not a national drug code, but has instead merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems.

Package Label Principal Display Panel:

75854-306-30 prenate chewable Â® a chewable rx prenatal vitamin with a delicious chocolate flavor with quatrefolicÂ® dietary supplement 30 tablets rx only avion pharmaceuticals chewable

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.