Davimet

Multivitamin


Puretek Corporation
Human Prescription Drug
NDC 59088-695
Davimet also known as Multivitamin is a human prescription drug labeled by 'Puretek Corporation'. National Drug Code (NDC) number for Davimet is 59088-695. This drug is available in dosage form of Tablet, Chewable. The names of the active, medicinal ingredients in Davimet drug includes .alpha.-tocopherol Acetate, Dl- - 10 mg/1 Ascorbic Acid - 24 mg/1 Cholecalciferol - 10 ug/1 Cyanocobalamin - 4.5 ug/1 Folic Acid - 1667 ug/1 Niacin - 13.5 mg/1 Pyridoxine Hydrochloride - 1.05 mg/1 Riboflavin - 1.2 mg/1 Sodium Ascorbate - 36 mg/1 Thiamine Mononitrate - 1.05 mg/1 and more. The currest status of Davimet drug is Active.

Drug Information:

Drug NDC: 59088-695
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: Davimet
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: Multivitamin
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Puretek Corporation
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:.ALPHA.-TOCOPHEROL ACETATE, DL- - 10 mg/1
ASCORBIC ACID - 24 mg/1
CHOLECALCIFEROL - 10 ug/1
CYANOCOBALAMIN - 4.5 ug/1
FOLIC ACID - 1667 ug/1
NIACIN - 13.5 mg/1
PYRIDOXINE HYDROCHLORIDE - 1.05 mg/1
RIBOFLAVIN - 1.2 mg/1
SODIUM ASCORBATE - 36 mg/1
THIAMINE MONONITRATE - 1.05 mg/1
VITAMIN A - 750 ug/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: 19 Sep, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 23 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:PureTek Corporation
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
N0000175594
M0014839
M0022788
N0000175950
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:WR1WPI7EW8
PQ6CK8PD0R
1C6V77QF41
P6YC3EG204
935E97BOY8
2679MF687A
68Y4CF58BV
TLM2976OFR
S033EH8359
8K0I04919X
81G40H8B0T
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]
Nicotinic Acid [EPC]
Vitamin A [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]
Nicotinic Acids [CS]
Vitamin A [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]
Nicotinic Acid [EPC]
Nicotinic Acids [CS]
Vitamin A [CS]
Vitamin A [EPC]
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
59088-695-5430 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-695-54)19 Sep, 2022N/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:

Davimet multivitamin sucrose croscarmellose sodium d&c red no. 27 fd&c blue no. 1 magnesium stearate cellulose, microcrystalline stearic acid vitamin a vitamin a ascorbic acid ascorbic acid sodium ascorbate ascorbic acid cholecalciferol cholecalciferol .alpha.-tocopherol acetate, dl- .alpha.-tocopherol, dl- pyridoxine hydrochloride pyridoxine thiamine mononitrate thiamine ion thiamine riboflavin riboflavin niacin niacin folic acid folic acid cyanocobalamin cyanocobalamin aspartame grape flavor light purple

Indications and Usage:

Indications and usage davimet™ multivitamin chewable tablets is indicated to provide significant amounts of vitamins a, c, d, e, thiamine, riboflavin, niacin, vitamin b6, vitamin b12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. contraindications: this product is contraindicated in patients with known hypersensitivity to any of its ingredients.

Warnings:

Warning keep out of the reach of children. in case of accidental overdose, seek professional assistance or contact a poison control center immediately. caution: should be chewed.

Dosage and Administration:

Dosage and administration one tablet daily, to be dissolved in the mouth or chewed before swallowing.

Contraindications:

Contraindications: this product is contraindicated in patients with known hypersensitivity to any of its ingredients.

Adverse Reactions:

Adverse reactions: folic acid: allergic sensitizations has been reported following both oral and parenteral administration of folic acid. adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. however, allergic and idiosyncratic reactions are possible at lower levels.

Description:

Each chewable tablet contains: vitamin a (as retinyl acetate)............................750 mcg rae vitamin c (as sodium ascorbate & ascorbic acid)........60 mg vitamin d3 (as cholecalciferol)...................................10 mcg vitamin e .....................................................................10 mg thiamin (as thiamine mononitrate)...........................1.05 mg riboflavin....................................................................1.2 mg niacin (as niacinamide).............................................13.5 mg vitamin b6 (as pyridoxine hydrochloride).................1.05 mg folate (as folic acid).....1667 mcg dfe (1000 mcg folic acid) vitamin b12 (as cyanocobalamin).............................4.5 mcg

How Supplied:

How supplied multivitamin chewable tablets are light purple with speckles, grape flavor, un-scored, round tablets. available on prescription only in bottles of 30 tablets – ndc 59088-695-54. dispense in a tight, light resistant container with a child resistant closure as defined in the usp/nf. all prescription substitutions using this product shall be pursuant to state statutes as applicable. this is not an orange book product.

Package Label Principal Display Panel:

Davimet™ manufactured in the usa by: puretek corporation panorama city, ca 91402 questions? call toll-free: 1-877-921-7873 label


Comments/ Reviews:

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