Pnv-select

Vitamin A Acetate, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Dl, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Biotin, Calcium Pantothenate, Calcium Carbonate, Ferrous Fumarate, Potassium Iodide, Magnesium Oxide, Zinc Oxide And Cupric Oxide

Acella Pharmaceuticals, Llc
Human Prescription Drug
NDC 42192-320

Pnv-select also known as Vitamin A Acetate, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Dl, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Biotin, Calcium Pantothenate, Calcium Carbonate, Ferrous Fumarate, Potassium Iodide, Magnesium Oxide, Zinc Oxide And Cupric Oxide is a human prescription drug labeled by 'Acella Pharmaceuticals, Llc'. National Drug Code (NDC) number for Pnv-select is 42192-320. This drug is available in dosage form of Tablet, Film Coated. The names of the active, medicinal ingredients in Pnv-select drug includes .alpha.-tocopherol Acetate, Dl- - 10 [iU]/1 Ascorbic Acid - 80 mg/1 Biotin - 300 ug/1 Calcium Carbonate - 120 mg/1 Calcium Pantothenate - 6 mg/1 Cholecalciferol - 400 [iU]/1 Cupric Oxide - 2 mg/1 Cyanocobalamin - 12 ug/1 Ferrous Fumarate - 27 mg/1 Folic Acid - 1 mg/1 and more. The currest status of Pnv-select drug is Active.

Drug Information:

Drug NDC:	42192-320
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:	Pnv-select
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:	Vitamin A Acetate, Ascorbic Acid, Cholecalciferol, Alpha-tocopherol Acetate, Dl, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Biotin, Calcium Pantothenate, Calcium Carbonate, Ferrous Fumarate, Potassium Iodide, Magnesium Oxide, Zinc Oxide And Cupric Oxide
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Acella Pharmaceuticals, Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Tablet, Film 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- - 10 [iU]/1 ASCORBIC ACID - 80 mg/1 BIOTIN - 300 ug/1 CALCIUM CARBONATE - 120 mg/1 CALCIUM PANTOTHENATE - 6 mg/1 CHOLECALCIFEROL - 400 [iU]/1 CUPRIC OXIDE - 2 mg/1 CYANOCOBALAMIN - 12 ug/1 FERROUS FUMARATE - 27 mg/1 FOLIC ACID - 1 mg/1 Load more... MAGNESIUM OXIDE - 30 ug/1 NIACINAMIDE - 20 mg/1 POTASSIUM IODIDE - 150 ug/1 PYRIDOXINE HYDROCHLORIDE - 20 mg/1 RIBOFLAVIN - 3.4 mg/1 THIAMINE MONONITRATE - 3 mg/1 VITAMIN A ACETATE - 2500 [iU]/1 ZINC OXIDE - 15 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:	01 Oct, 1990
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	16 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:	Acella Pharmaceuticals, 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 6SO6U10H04 H0G9379FGK 568ET80C3D 1C6V77QF41 V1XJQ704R4 P6YC3EG204 R5L488RY0Q 935E97BOY8 Load more... 3A3U0GI71G 25X51I8RD4 1C4QK22F9J 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] Calculi Dissolution Agent [EPC] Cations Divalent [CS] Copper Absorption Inhibitor [EPC] Decreased Copper Ion Absorption [PE] Increased Coagulation Factor Activity [PE] Increased Large Intestinal Motility [PE] Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] Inhibition Small Intestine Fluid/Electrolyte Absorption [PE] Magnesium Ion Exchange Activity [MoA] Osmotic Activity [MoA] Osmotic Laxative [EPC] Stimulation Large Intestine Fluid/Electrolyte Secretion [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 NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
42192-320-90	90 TABLET, FILM COATED in 1 BOTTLE (42192-320-90)	04 Nov, 2009	N/A	No
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.

Other medicines with the same generic name

Pnv-select

Vitamin A Acetate & more..

Tablet, Film Coated
Acella Pharmaceuticals, LLC
NDC: 42192-320

Product Elements:

Pnv-select vitamin a acetate, ascorbic acid, cholecalciferol, alpha-tocopherol acetate, dl, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, zinc oxide and cupric oxide calcium phosphate, dibasic, anhydrous cellulose, microcrystalline stearic acid croscarmellose sodium silicon dioxide magnesium stearate titanium dioxide vitamin a acetate vitamin a 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 biotin biotin calcium pantothenate pantothenic acid calcium carbonate calcium cation ferrous fumarate ferrous cation potassium iodide iodide ion magnesium oxide magnesium cation zinc oxide zinc cation cupric oxide cupric cation 320

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 immediately. keep this and all medications out of the reach of children.

Indications and Usage:

Indications: pnv-select is a multivitamin/multimineral nutritional supplement indicated for use in the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation.

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: pnv-select is a prescription prenatal dietary supplement tablet that contains multivitamins and minerals, which are delivered in the form of a white, oval, oil-and water-soluble, film-coated tablet debossed with â320â on one side. table other ingredients: dicalcium phosphate, cellulose, croscarmellose sodium, stearic acid, silicon dioxide, magnesium stearate, film coating (hydroxy propyl methyl cellulose, triacetin, titanium dioxide).

How Supplied:

How supplied: pnv-select is supplied in child-resistant bottles of 90 tablets (42192-320-90). the listed product is not a national drug code, but has merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems.

Package Label Principal Display Panel:

Principal display panel - film coated tablets ndc 42192-320-90 pnv-select prenatal multivitamin dietary supplement film coated tablets rx only 90 tablets acella pharmaceuticals, llc pnv- select

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.