Tricare Prenatal

Ascorbic Acid, Cholecalciferol, Dl-.alpha.-tocopherol Acetate, Thiamine Hydrochloride, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Ferrous Fumarate, Zinc Oxide, Cupric Sulfate


Medecor Pharma, Llc
Human Prescription Drug
NDC 67112-101
Tricare Prenatal also known as Ascorbic Acid, Cholecalciferol, Dl-.alpha.-tocopherol Acetate, Thiamine Hydrochloride, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Ferrous Fumarate, Zinc Oxide, Cupric Sulfate is a human prescription drug labeled by 'Medecor Pharma, Llc'. National Drug Code (NDC) number for Tricare Prenatal is 67112-101. This drug is available in dosage form of Tablet, Coated. The names of the active, medicinal ingredients in Tricare Prenatal drug includes .alpha.-tocopherol Acetate, Dl- - 30 [iU]/1 Ascorbic Acid - 100 mg/1 Calcium Carbonate - 200 mg/1 Cholecalciferol - 400 [iU]/1 Cupric Sulfate - 2 mg/1 Cyanocobalamin - 12 ug/1 Ferrous Fumarate - 27 mg/1 Folic Acid - 1 mg/1 Niacinamide - 20 mg/1 Pyridoxine Hydrochloride - 3.1 mg/1 and more. The currest status of Tricare Prenatal drug is Active.

Drug Information:

Drug NDC: 67112-101
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: Tricare Prenatal
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, Dl-.alpha.-tocopherol Acetate, Thiamine Hydrochloride, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Ferrous Fumarate, Zinc Oxide, Cupric Sulfate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Medecor Pharma, Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Tablet, 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 ACETATE, DL- - 30 [iU]/1
ASCORBIC ACID - 100 mg/1
CALCIUM CARBONATE - 200 mg/1
CHOLECALCIFEROL - 400 [iU]/1
CUPRIC SULFATE - 2 mg/1
CYANOCOBALAMIN - 12 ug/1
FERROUS FUMARATE - 27 mg/1
FOLIC ACID - 1 mg/1
NIACINAMIDE - 20 mg/1
PYRIDOXINE HYDROCHLORIDE - 3.1 mg/1
RIBOFLAVIN - 1.6 mg/1
THIAMINE HYDROCHLORIDE - 1.6 mg/1
ZINC OXIDE - 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: 01 Jan, 2012
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 18 Jan, 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:Medecor Pharma, 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:N0000193618
M0001797
M0022797
N0000175952
M0022794
N0000175951
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:WR1WPI7EW8
PQ6CK8PD0R
H0G9379FGK
1C6V77QF41
LRX7AJ16DT
P6YC3EG204
R5L488RY0Q
935E97BOY8
25X51I8RD4
68Y4CF58BV
TLM2976OFR
M572600E5P
SOI2LOH54Z
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]
Cations
Divalent [CS]
Copper Absorption Inhibitor [EPC]
Decreased Copper Ion Absorption [PE]
Increased Coagulation Factor Activity [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 NDCDescriptionMarketing Start DateMarketing End DateSample Available
67112-101-00100 TABLET, COATED in 1 BOTTLE, PLASTIC (67112-101-00)01 Jan, 2012N/ANo
67112-101-3030 TABLET, COATED in 1 BOTTLE, PLASTIC (67112-101-30)01 Jan, 2012N/ANo
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.

Product Elements:

Tricare prenatal ascorbic acid, cholecalciferol, dl-.alpha.-tocopherol acetate, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide, cupric sulfate silicon dioxide carnauba wax fd&c blue no. 1 fd&c blue no. 2 fd&c red no. 40 magnesium stearate cellulose, microcrystalline crospovidone ascorbic acid ascorbic acid cholecalciferol cholecalciferol .alpha.-tocopherol acetate, dl- .alpha.-tocopherol, dl- thiamine hydrochloride thiamine ion riboflavin riboflavin niacinamide niacinamide pyridoxine hydrochloride pyridoxine folic acid folic acid cyanocobalamin cyanocobalamin calcium carbonate calcium cation ferrous fumarate ferrous cation zinc oxide zinc cation cupric sulfate cupric cation light blue mp;101

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 right away.

Indications and Usage:

Indications and usage: tricare prenatal™ tablets are indicated to provide vitamin and mineral supplementation throughout pregnancy and during the postnatal period for both the lactating and non-lactating mother. it is also useful for improving nutritional status prior to conception.

General Precautions:

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

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.

Adverse Reactions:

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

Description:

Description: each light blue film coated tablet contains: vitamin c (ascorbic acid) 100 mg vitamin d-3 (cholecalciferol) 400 iu vitamin e (dl-alpha tocopheryl acetate) 30 iu vitamin b-1 (thiamine hcl) 1.6 mg vitamin b-2 (riboflavin) 1.6 mg niacin (niacinamide) 20 mg vitamin b-6 (pyridoxine hcl) 3.1 mg folic acid 1 mg vitamin b-12 (cyanocobalamin) 12 mcg calcium (calcium carbonate) 200 mg iron (ferrous fumarate) 27 mg zinc (zinc oxide) 10 mg copper (cupric sulfate) 2 mg

How Supplied:

How supplied: tricar e prenatal™ multivitamin/mineral tablets for oral administration are supplied as light blue, film coated tablets, debossed mp 101 with a partial bisect through the tablets on one side. in a child resistant plastic bottle of 30 tablets (ndc 67112-101-30).

Package Label Principal Display Panel:

Label_30 label_100


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.