Pnv-dha

Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Pyridoxine, Folic Acid, Calcium, Ferrous Fumarate, Doconexent

Acella Pharmaceuticals, Llc
Human Prescription Drug
NDC 42192-323

Pnv-dha also known as Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Pyridoxine, Folic Acid, Calcium, Ferrous Fumarate, Doconexent is a human prescription drug labeled by 'Acella Pharmaceuticals, Llc'. National Drug Code (NDC) number for Pnv-dha is 42192-323. This drug is available in dosage form of Capsule, Gelatin Coated. The names of the active, medicinal ingredients in Pnv-dha drug includes .alpha.-tocopherol Acetate, Dl- - 30 [iU]/1 Ascorbic Acid - 28 mg/1 Calcium - 160 mg/1 Cholecalciferol - 400 [iU]/1 Doconexent - 300 mg/1 Ferrous Fumarate - 27 mg/1 Folic Acid - 1.25 mg/1 Pyridoxine - 25 mg/1 . The currest status of Pnv-dha drug is Active.

Drug Information:

Drug NDC:	42192-323
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-dha
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, .alpha.-tocopherol Acetate, Dl-, Pyridoxine, Folic Acid, Calcium, Ferrous Fumarate, Doconexent
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:	Capsule, Gelatin 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 - 28 mg/1 CALCIUM - 160 mg/1 CHOLECALCIFEROL - 400 [iU]/1 DOCONEXENT - 300 mg/1 FERROUS FUMARATE - 27 mg/1 FOLIC ACID - 1.25 mg/1 PYRIDOXINE - 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 Oct, 2010
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.
UPC:	0342192323308
UPC stands for Universal Product Code.
NUI:	N0000193618 M0001797 M0003153 N0000175901 N0000175597 N0000020074 M0022797 N0000175952 N0000192800 N0000005657 N0000175452
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	WR1WPI7EW8 PQ6CK8PD0R SY7Q814VUP 1C6V77QF41 ZAD9OKH9JC R5L488RY0Q 935E97BOY8 KV2JZ1BI6Z
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 MOA:	Phosphate Chelating Activity [MoA]
Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`.
Pharmacologic Class EPC:	Vitamin C [EPC] Calcium [EPC] Phosphate Binder [EPC] Vitamin D [EPC] Vitamin B6 Analog [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] Calcium [CS] Vitamin D [CS] Vitamin B 6 [Chemical/Ingredient] Analogs/Derivatives [Chemical/Ingredient]
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] Calcium [CS] Calcium [EPC] Phosphate Binder [EPC] Phosphate Chelating Activity [MoA] Vitamin B 6 [Chemical/Ingredient] 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
42192-323-30	30 CAPSULE, GELATIN COATED in 1 BOTTLE (42192-323-30)	01 Oct, 2010	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-dha

Ascorbic Acid & more..

Capsule, Gelatin Coated
Acella Pharmaceuticals, LLC
NDC: 42192-323

Product Elements:

Pnv-dha ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine, folic acid, calcium, ferrous fumarate, doconexent gelatin type b bovine (230 bloom) glycerin soybean oil lecithin, soybean water yellow wax fd&c red no. 40 titanium dioxide orange ethyl vanillin fd&c yellow no. 6 fd&c blue no. 1 ascorbic acid ascorbic acid calcium calcium ferrous fumarate ferrous cation cholecalciferol cholecalciferol .alpha.-tocopherol acetate, dl- .alpha.-tocopherol, dl- pyridoxine pyridoxine folic acid folic acid doconexent doconexent 323

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.

Indications and Usage:

Indications pnv-dha + docusate is a multivitamin/mineral prescription dietary supplement indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.

Warnings:

Warning ingestion of more than 3 grams of omega-3 fatty acids (such as dha) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and international normalized ratio (inr). administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.

Dosage and Administration:

Dosage and administration usual adult dose is one (1) softgel daily or as directed by a physician. keep out of reach of children.

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. caution: exercise caution to ensure that the prescribed dosage of dha does not exceed 1 grams (1000 mg) daily.

Description:

Description pnv-dha + docusate is a prescription prenatal/postnatal multivitamin/multimineral softgel with dha. each softgel is red in color and imprinted with â323â on one side. â daily value (dv) not established. supplement facts serving size: 1 softgel amount per serving % daily value vitamin c (as ascorbic acid, usp) 28 mg 47% calcium (tribasic calcium phosphate, nf) 160 mg 16% iron (as ferrous fumarate, usp) 27 mg 150% vitamin d 3 (as cholecalciferol, usp) 400 iu 100% vitamin e (as d-alpha-tocopherol acetate, usp) 30 iu 100% vitamin b 6 (as pyridoxine hcl, usp) 25 mg 1250% folic acid, usp 1.25 mg 313% dha (docosahexaenoic acid) 300 mg â docusate sodium, usp 55 mg â other ingredients bovine gelatin, glycerin, soybean oil, soy lecithin, purified water, yellow beeswax, fd&c red # 40, titanium dioxide, orange cream flavor, ethyl vanillin, fd&c yellow # 6, and fd&c blue #1. contains soy. indications pnv-dha + docusate is a multivitamin/mineral prescription dietary supplement indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers. contraindications this product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

How Supplied:

How supplied pnv-dha + docusate is supplied in child-resistant bottles of 30 softgels (42192-323-30). the listed product number is not a national drug code, but has merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems. store at 20Â°- 25Â°c (68Â° - 77Â°f); excursions permitted to 15Â°- 30Â°c (59Â° - 86Â°f) [see usp, âcontrolled room temperatureâ]. protect from light and heat. keep this and all medications out of the reach of children. all prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. please note: this is not an orange book product and has not been subjected to fda therapeutic equivalency or other equivalency testing. no representation is made as to generic status or bioequivalency. each person recommending a prescription substitution using this product shall make such recommendations based on each such personâs pr Read more...

ofessional opinion and knowledge, upon evaluating the dietary ingredients, other ingredients and information provided herein. these statements have not been evaluated by the food and drug administration. this product is not intended to diagnose, treat, cure or prevent any disease. manufactured for: acella pharmaceuticals, llc alpharetta, ga 30022 1-800-541-4802 rev. 0717-01

Package Label Principal Display Panel:

Principal display panel - 30 softgel tablets 42192-323-30 pnv-dha+docusate r x prenatal vitamin and dha dietary supplement r x only 30 softgels acella pharmaceuticals, llc principal display panel - film coated tablets

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.