NDC 67112-402 Tricare Prenatal Dha One Rx Multivitamin

Fish Oil, Dha, Epa, Vitamins B-1, B-2, B-3, B-6, B-12, C, D3, E, Biotin, Iron, Zinc, Copper, Iodine, Docusate Sodium

NDC Product Code 67112-402

NDC Code: 67112-402

Proprietary Name: Tricare Prenatal Dha One Rx Multivitamin What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Fish Oil, Dha, Epa, Vitamins B-1, B-2, B-3, B-6, B-12, C, D3, E, Biotin, Iron, Zinc, Copper, Iodine, Docusate Sodium What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
PURPLE (C48327)
Shape: CAPSULE (C48336)
Size(s):
21 MM
Imprint(s):
DHA402
Score: 1

NDC Code Structure

  • 67112 - Medecor Pharma, Llc
    • 67112-402 - Tricare Prenatal Dha One Rx

NDC 67112-402-30

Package Description: 30 CAPSULE, GELATIN COATED in 1 BOTTLE

NDC Product Information

Tricare Prenatal Dha One Rx Multivitamin with NDC 67112-402 is a a human prescription drug product labeled by Medecor Pharma, Llc. The generic name of Tricare Prenatal Dha One Rx Multivitamin is fish oil, dha, epa, vitamins b-1, b-2, b-3, b-6, b-12, c, d3, e, biotin, iron, zinc, copper, iodine, docusate sodium. The product's dosage form is capsule, gelatin coated and is administered via oral form.

Labeler Name: Medecor Pharma, 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.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Tricare Prenatal Dha One Rx Multivitamin Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • FISH OIL 500 mg/1
  • DOCONEXENT 215 mg/1
  • ICOSAPENT 45 mg/1
  • THIAMINE MONONITRATE 3 mg/1
  • RIBOFLAVIN 3.4 mg/1
  • INOSITOL NIACINATE 20 mg/1
  • PYRIDOXINE HYDROCHLORIDE 25 mg/1
  • CYANOCOBALAMIN 100 ug/1
  • FOLIC ACID 1 mg/1
  • ASCORBIC ACID 60 mg/1
  • CHOLECALCIFEROL 800 [iU]/1
  • .ALPHA.-TOCOPHEROL, D- 30 [iU]/1
  • BIOTIN 300 ug/1
  • FERROUS FUMARATE 27 mg/1
  • ZINC SULFATE MONOHYDRATE 10 mg/1
  • CUPRIC SULFATE ANHYDROUS 2 mg/1
  • POTASSIUM IODIDE 150 ug/1
  • DOCUSATE SODIUM 25 ug/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SORBITOL (UNII: 506T60A25R)
  • WATER (UNII: 059QF0KO0R)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Vitamin C - [EPC] (Established Pharmacologic Class)
  • Ascorbic Acid - [CS]
  • Vitamin D - [CS]
  • Vitamin D - [EPC] (Established Pharmacologic Class)
  • Copper Absorption Inhibitor - [EPC] (Established Pharmacologic Class)
  • Decreased Copper Ion Absorption - [PE] (Physiologic Effect)
  • Vitamin B6 Analog - [EPC] (Established Pharmacologic Class)
  • Vitamin B 6 - [Chemical/Ingredient]
  • Analogs/Derivatives - [Chemical/Ingredient]
  • Vitamin B 12 - [CS]
  • Vitamin B12 - [EPC] (Established Pharmacologic Class)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Medecor Pharma, Llc
Labeler Code: 67112
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 03-15-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Tricare Prenatal Dha One Rx Multivitamin Product Label Images

Tricare Prenatal Dha One Rx Multivitamin Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description:

Each purple softgel contains:Essential Fatty AcidsFish Oil Concentrate 10/50 TG500 mg     DHA215 mg     EPA45 mgVitaminsVitamin B-1 (Thiamine Nitrate)3 mgVitamin B-2 (Riboflavin)3.4 mgVitamin B-3 (Inositol Nicotinate)20 mgVitamin B-6 (Pyridoxine Hydrochloride)25 mgVitamin B-12 (Cyanocobalamin)100 mcgFolic Acid1 mgVitamin C (Ascorbic Acid)60 mgVitamin D3 (Cholecalciferol)800 IUVitamin E (d-alpha-Tocopherol)30 IUBiotin300 mcgMineralsIron (Ferrous Fumarate)27 mgZinc (Zinc Sulfate Monohydrate)10 mgCopper (Cupric Sulfate Anhydrous)2 mgOther Active Ingredients:Docusate Sodium (with 15% sodium benzoate)25 mg

Inactive Ingredients:

Gelatin Capsule (Bovine Gelatin, Glycerin, Sorbitol Sorbitan Solution, Purified Water, Titanium Dioxide, FD&C Red #40, FD&C Red #3, FD&C Blue #1, Yellow Beeswax, Soy Lecithin

Contraindications:

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

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.

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 aniticoagulants and in those known to have an inherited or acquired predisposition to bleeding.

General Precautions

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B-12 is deficient.

Precautions:

Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

Adverse Reactions:

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

Dosage And Administration:

One softgel daily or as directed by a physician.

How Supplied:

TriCare Prenatal™ DHA ONE® RX Multivitamin/Mineral Softgels for oral administration are supplied as purple softgels, imprinted in white ink: DHA 402 in a child-resistant plastic bottle of 30 softgels. (NDC 67112-402-30).

Storage And Handling

NOTICE:  Contact with moisture may produce surface discoloration or erosion of the softgel.Store at controlled room temperature of:  20o-25oC (68o-77oF).Excursions permitted to 15o-30oC (59o-86oF).KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.Marketed by Medecor Pharma LLC, Baton Rouge, LA

* Please review the disclaimer below.

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