Natachew

.beta.-carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, D-, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Iron, Niacinamide


Eckson Labs, Llc
Human Prescription Drug
NDC 44118-902
Natachew also known as .beta.-carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, D-, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Iron, Niacinamide is a human prescription drug labeled by 'Eckson Labs, Llc'. National Drug Code (NDC) number for Natachew is 44118-902. This drug is available in dosage form of Tablet, Chewable. The names of the active, medicinal ingredients in Natachew drug includes .alpha.-tocopherol Acetate, D- - 20 [iU]/1 .beta.-carotene - 2700 [iU]/1 Ascorbic Acid - 120 mg/1 Cholecalciferol - 400 [iU]/1 Cyanocobalamin - 12 ug/1 Folic Acid - 1 mg/1 Iron - 28 mg/1 Niacinamide - 20 mg/1 Pyridoxine Hydrochloride - 10 mg/1 Riboflavin - 3 mg/1 and more. The currest status of Natachew drug is Active.

Drug Information:

Drug NDC: 44118-902
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: Natachew
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: .beta.-carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, D-, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Iron, Niacinamide
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Eckson Labs, 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:.ALPHA.-TOCOPHEROL ACETATE, D- - 20 [iU]/1
.BETA.-CAROTENE - 2700 [iU]/1
ASCORBIC ACID - 120 mg/1
CHOLECALCIFEROL - 400 [iU]/1
CYANOCOBALAMIN - 12 ug/1
FOLIC ACID - 1 mg/1
IRON - 28 mg/1
NIACINAMIDE - 20 mg/1
PYRIDOXINE HYDROCHLORIDE - 10 mg/1
RIBOFLAVIN - 3 mg/1
THIAMINE MONONITRATE - 2 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: 15 Oct, 2012
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:Eckson Labs, 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:A7E6112E4N
PQ6CK8PD0R
1C6V77QF41
P6YC3EG204
935E97BOY8
E1UOL152H7
25X51I8RD4
68Y4CF58BV
TLM2976OFR
8K0I04919X
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]
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
44118-902-059 BOTTLE in 1 CARTON (44118-902-05) / 5 TABLET, CHEWABLE in 1 BOTTLE15 Oct, 2012N/AYes
44118-902-9090 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (44118-902-90)15 Oct, 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:

Natachew .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, folic acid, cyanocobalamin, iron, niacinamide sucrose d&c red no. 7 sucralose cellulose, microcrystalline polyethylene glycol 400 stearic acid magnesium stearate .beta.-carotene .beta.-carotene ascorbic acid ascorbic acid cholecalciferol cholecalciferol .alpha.-tocopherol acetate, d- .alpha.-tocopherol, d- thiamine mononitrate thiamine ion thiamine mononitrate riboflavin riboflavin pyridoxine hydrochloride pyridoxine folic acid folic acid cyanocobalamin cyanocobalamin iron iron niacinamide niacinamide 902

Indications and Usage:

Indications and usage: natachew ® is a prescription pre/post-natal multivitamin, multimineral indicated for use in improving the nutritional status of women throughout pregnancy, as well as in the post-natal period for both lactating and non-lactating mothers. this product is also useful in improving the nutritional status of women prior to conception.

Warnings and Cautions:

Warnings and precautions: folic acid is improper therapy in the treatment of pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive. while prescribing this product for pregnant women, nursing mothers, or for women prior to conception, their medical condition and use of other drugs, herbs, and/or supplements should be considered. 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. keep this and all medication out of the reach of children.

Dosage and Administration:

Dosage and administration: one tablet daily with or without food or as prescribed by a physician.

Contraindications:

Contraindications: this product is contraindicated in patients with 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. you should call your doctor for medical advice about side effects. to report a serious adverse event, call 1-855-899-4237.

Description:

Supplement facts serving size: 1 tablet amount per serving vitamin a (beta carotene) 2,700 iu vitamin c (sodium ascorbate and ascorbic acid) 120 mg vitamin d 3 (cholecalciferol) 400 iu vitamin e (dl-alpha tocopheryl acetate) 20 iu vitamin b 1 (thiamine mononitrate) 2 mg vitamin b 2 (riboflavin) 3 mg vitamin b 6 (pyridoxine hcl) 10 mg folic acid 1 mg vitamin b 12 (cyanocobalamin) 12 mcg iron (ferrous fumarate and ferrous ii bis-glycinate chelate) 28 mg niacinamide 20 mg other ingredients: sugar, d&c red #7 calcium lake, sucralose, flavor, microcrystalline cellulose, polyethylene glycol 400, stearic acid, magnesium stearate

How Supplied:

How supplied: natachew ® is supplied as a red tablet, imprinted “902”, in child-resistant bottles of 90 tablets, ndc 44118-902-90. store between 15°c and 30°c (between 59°f and 86°f). tamper evident by foil seal under cap. manufactured for: eckson labs, llc 1000 n. west st., suite 1200, #927 wilmington, de 19801 vm2 rev. 04/2017 827453

Package Label Principal Display Panel:

Label.jpg


Comments/ Reviews:

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