Prenatal Plus Vitamins

Prenatal With Ferrous Fumarate And Folic Acid


Patrin Pharma, Inc.
Human Prescription Drug
NDC 39328-106
Prenatal Plus Vitamins also known as Prenatal With Ferrous Fumarate And Folic Acid is a human prescription drug labeled by 'Patrin Pharma, Inc.'. National Drug Code (NDC) number for Prenatal Plus Vitamins is 39328-106. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Prenatal Plus Vitamins drug includes .alpha.-tocopherol Acetate, Dl- - 10 mg/1 Ascorbic Acid - 120 mg/1 Beta Carotene - 276 ug/1 Calcium Carbonate - 200 mg/1 Cholecalciferol - 10 ug/1 Cupric Oxide - 2 mg/1 Cyanocobalamin - 12 ug/1 Ferrous Fumarate - 27 mg/1 Folic Acid - 1667 ug/1 Niacinamide - 20 mg/1 and more. The currest status of Prenatal Plus Vitamins drug is Active.

Drug Information:

Drug NDC: 39328-106
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: Prenatal Plus Vitamins
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: Prenatal With Ferrous Fumarate And Folic Acid
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Patrin Pharma, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Tablet
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 - 120 mg/1
BETA CAROTENE - 276 ug/1
CALCIUM CARBONATE - 200 mg/1
CHOLECALCIFEROL - 10 ug/1
CUPRIC OXIDE - 2 mg/1
CYANOCOBALAMIN - 12 ug/1
FERROUS FUMARATE - 27 mg/1
FOLIC ACID - 1667 ug/1
NIACINAMIDE - 20 mg/1
PYRIDOXINE HYDROCHLORIDE - 10 mg/1
RIBOFLAVIN - 3 mg/1
THIAMINE MONONITRATE - 1.84 mg/1
VITAMIN A ACETATE - 924 ug/1
ZINC OXIDE - 25 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 Apr, 2013
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 23 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:Patrin Pharma, Inc.
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
01YAE03M7J
H0G9379FGK
1C6V77QF41
V1XJQ704R4
P6YC3EG204
R5L488RY0Q
935E97BOY8
25X51I8RD4
68Y4CF58BV
TLM2976OFR
8K0I04919X
3LE3D9D6OY
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]
Increased Coagulation Factor Activity [PE]
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
39328-106-10100 TABLET in 1 BOTTLE, PLASTIC (39328-106-10)01 Apr, 2013N/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:

Prenatal plus vitamins prenatal with ferrous fumarate and folic acid vitamin a acetate vitamin a beta carotene beta carotene ascorbic acid ascorbic acid cholecalciferol cholecalciferol .alpha.-tocopherol acetate, dl- .alpha.-tocopherol, dl- thiamine mononitrate thiamine ion thiamine riboflavin riboflavin niacinamide niacinamide pyridoxine hydrochloride pyridoxine folic acid folic acid cyanocobalamin cyanocobalamin calcium carbonate calcium cation ferrous fumarate ferrous cation zinc oxide zinc oxide cupric oxide cupric cation hypromellose, unspecified magnesium stearate maltodextrin microcrystalline cellulose polyethylene glycol 400 stearic acid titanium dioxide fd&c blue no. 2 fd&c red no. 40 fd&c yellow no. 6 beige oval p;5

Boxed Warning:

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

Dosage and Administration:

Directions use before, during and after pregnancy under the supervision of a medical professional. one tablet daily or as prescribed.

Description:

Supplement facts serving size: 1 tablet amount per serving % daily value daily value is for pregnant and lactating women vitamin a 1200 mcg 92% (acetate and beta carotene) rae vitamin c (ascorbic acid) 120 mg 100% vitamin d-3 (cholecalciferol) 10 mcg 67% vitamin e (dl-α tocopheryl acetate) 10 mg 53% vitamin b-1 (thiamine mononitrate) 1.84 mg 131% vitamin b-2 (riboflavin) 3 mg 188% niacin (niacinamide) 20 mg 111% vitamin b-6 (pyridoxine hcl) 10 mg 500% folic acid 1667 mcg 278% dfe (1 mg) vitamin b-12 (cyanocobalamin) 12 mcg 429% calcium (calcium carbonate) 200 mg 15% iron (ferrous fumarate) 27 mg 100% zinc (zinc oxide) 25 mg 192% copper(cupric oxide) 2 mg 154% other ingredients: hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, stearic acid, titanium dioxide, fd&c blue #2 lake, fd&c red #40 lake, fd&c yellow #6 lake

Description prenatal plus vitamins is a prescription folic acid containing dietary vitamin and mineral supplement for women before, during and after pregnancy.

Package Label Principal Display Panel:

Principal display panel - 100 tablet bottle label rx only ndc 39328-106-10 prenatal plus vitamins 27 mg fe & 1 mg fa before, during and after pregnancy 100 tablets made in the usa patrin pharma principal display panel - 100 tablet bottle label


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.