Prenate Dha

Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol, Dl-, Folic Acid, Pyridoxine Hydrochloride, Cyanocobalamin, Calcium Formate, Ferrous Asparto Glycinate, Magnesium Oxide And Doconexent

Avion Pharmaceuticals, Llc
Human Prescription Drug
NDC 75854-312

Prenate Dha also known as Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol, Dl-, Folic Acid, Pyridoxine Hydrochloride, Cyanocobalamin, Calcium Formate, Ferrous Asparto Glycinate, Magnesium Oxide And Doconexent is a human prescription drug labeled by 'Avion Pharmaceuticals, Llc'. National Drug Code (NDC) number for Prenate Dha is 75854-312. This drug is available in dosage form of Capsule, Gelatin Coated. The names of the active, medicinal ingredients in Prenate Dha drug includes .alpha.-tocopherol, Dl- - 40 [iU]/1 Ascorbic Acid - 90 mg/1 Calcium Formate - 155 mg/1 Cholecalciferol - 400 [iU]/1 Cyanocobalamin - 25 ug/1 Doconexent - 300 mg/1 Ferrous Asparto Glycinate - 18 mg/1 Folic Acid - 1 mg/1 Magnesium Oxide - 50 mg/1 Pyridoxine Hydrochloride - 26 mg/1 . The currest status of Prenate Dha drug is Active.

Drug Information:

Drug NDC:	75854-312
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 Dha
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:	Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol, Dl-, Folic Acid, Pyridoxine Hydrochloride, Cyanocobalamin, Calcium Formate, Ferrous Asparto Glycinate, Magnesium Oxide And Doconexent
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:	Capsule, Gelatin Coated
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:	.ALPHA.-TOCOPHEROL, DL- - 40 [iU]/1 ASCORBIC ACID - 90 mg/1 CALCIUM FORMATE - 155 mg/1 CHOLECALCIFEROL - 400 [iU]/1 CYANOCOBALAMIN - 25 ug/1 DOCONEXENT - 300 mg/1 FERROUS ASPARTO GLYCINATE - 18 mg/1 FOLIC ACID - 1 mg/1 MAGNESIUM OXIDE - 50 mg/1 PYRIDOXINE HYDROCHLORIDE - 26 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:	05 Jun, 2014
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	16 Jun, 2026
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.
UPC:	0375854312303
UPC stands for Universal Product Code.
NUI:	N0000193618 M0001797 M0022797 N0000175952 M0022794 N0000175951
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	7QWA1RIO01 PQ6CK8PD0R NP3JD65NPY 1C6V77QF41 P6YC3EG204 ZAD9OKH9JC H7426RGB3L 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 C [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:	Ascorbic Acid [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] Ascorbic Acid [CS] 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 C [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
75854-312-30	30 CAPSULE, GELATIN COATED in 1 BOTTLE (75854-312-30)	05 Jun, 2014	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 Dha

Ascorbic Acid & more..

Capsule, Gelatin Coated
Avion Pharmaceuticals, LLC
NDC: 75854-312

Product Elements:

Prenate dha ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, calcium formate, ferrous asparto glycinate, magnesium oxide and doconexent gelatin glycerin lecithin, soybean soybean oil white wax water fd&c blue no. 1 titanium dioxide fd&c red no. 3 ascorbic acid ascorbic acid cholecalciferol cholecalciferol .alpha.-tocopherol, dl- .alpha.-tocopherol, dl- folic acid folic acid pyridoxine hydrochloride pyridoxine cyanocobalamin cyanocobalamin calcium formate calcium cation ferrous asparto glycinate ferrous cation magnesium oxide magnesium cation doconexent doconexent opaque 301

Boxed Warning:

Warning: accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. keep this product out of reach of children. in case of accidental overdose, call a doctor or poison control center immediately.

Indications and Usage:

Indications: prenate dha Â® is a multivitamin/multimineral fatty acid 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 dha Â® can also be beneficial in improving the nutritional status of women prior to conception.

Warnings:

Warning: ingestion of more than 3 grams of omega-3 fatty acids (such as dha) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and international normalized ratio (inr). administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.

Dosage and Administration:

Dosage and administration: before, during and/or after pregnancy, one softgel daily or as directed by a physician.

Contraindications:

Contraindications: prenate dha Â® is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Adverse Reactions:

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

Description:

Description: prenate dha Â® is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. each softgel is blue in color, opaque, and imprinted with âdhaâ on one side and blank on the other. prenate dha Â® contains fish oil and soy. prenate

How Supplied:

How supplied: bottles of 30 softgels (75854-312-30). the listed product number is not a national drug code. instead, avion pharmaceuticals has assigned a product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems.

Package Label Principal Display Panel:

Package label.principal display panel 75854-312-30 prenate dha Â® rx prenatal vitamin & dha key vitamins, minerals, and dha support nutrition gluten free rx only dietary supplement 30 softgels dha

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.