NDC 42192-343 Prenaissance Plus

Calcium Citrate, Iron Pentacarbonyl, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Pyridoxine Hydrochloride, Folic Acid, Docusate Sodium And Doconexent

NDC Product Code 42192-343

NDC Code: 42192-343

Proprietary Name: Prenaissance Plus What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Calcium Citrate, Iron Pentacarbonyl, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Pyridoxine Hydrochloride, Folic Acid, Docusate Sodium And Doconexent What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
PURPLE (C48327)
Shape: CAPSULE (C48336)
Size(s):
25 MM
Imprint(s):
343
Score: 1

NDC Code Structure

  • 42192 - Acella Pharmaceuticals, Llc

NDC 42192-343-30

Package Description: 30 CAPSULE, LIQUID FILLED in 1 CAPSULE

NDC Product Information

Prenaissance Plus with NDC 42192-343 is a a human prescription drug product labeled by Acella Pharmaceuticals, Llc. The generic name of Prenaissance Plus is calcium citrate, iron pentacarbonyl, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, docusate sodium and doconexent. The product's dosage form is capsule, liquid filled and is administered via oral form.

Labeler Name: Acella Pharmaceuticals, Llc

Dosage Form: Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Prenaissance Plus Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • CALCIUM CITRATE 100 mg/1
  • IRON PENTACARBONYL 28 mg/1
  • CHOLECALCIFEROL 400 [iU]/1
  • .ALPHA.-TOCOPHEROL ACETATE, DL- 30 [iU]/1
  • PYRIDOXINE HYDROCHLORIDE 25 mg/1
  • FOLIC ACID 1 mg/1
  • DOCUSATE SODIUM 50 mg/1
  • DOCONEXENT 250 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • SOYBEAN OIL (UNII: 241ATL177A)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • ETHYL VANILLIN (UNII: YC9ST449YJ)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Vitamin B6 Analog - [EPC] (Established Pharmacologic Class)
  • Vitamin B 6 - [Chemical/Ingredient]
  • Analogs/Derivatives - [Chemical/Ingredient]
  • Blood Coagulation Factor - [EPC] (Established Pharmacologic Class)
  • Increased Coagulation Factor Activity - [PE] (Physiologic Effect)
  • Calcium - [CS]
  • Cations -
  • Divalent - [CS]
  • Vitamin D - [CS]
  • Vitamin D - [EPC] (Established Pharmacologic Class)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Acella Pharmaceuticals, Llc
Labeler Code: 42192
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 10-07-2011 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2019 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Prenaissance Plus Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Rx Only

EACH SOFTGEL CONTAINS:Calcium (Calcium citrate)100 mgIron (Carbonyl Iron)28 mgVitamin D3 (Cholecalciferol)400 IUVitamin E (dl-alpha tocopherol acetate)30 IUVitamin B6 (Pyridoxine HCI)25 mgFolic Acid1 mgDocusate Sodium50 mgDHA (Docosahexaenoic acid)250 mg

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 person’s professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical information provided herein.MANUFACTURED FOR: Acella Pharmaceuticals, LLC Alpharetta, GA 30009

Description:

Prenaissance Plus is a prescription prenatal/postnatal multivitamin/multimineral softgel capsule with DHA. Each softgel is purple in color, opaque and imprinted with "343" on one side.

Other Ingredients:

Soybean oil, yellow bee's wax, lecithin, natural orange cream flavoring, gelatin, glycerine, purified water, carmine, titanium dioxide, ethyl vanillin, FD&C#40, and FD&C Blue #1.

Indications:

Prenaissance Plus is a multivitamin/mineral prescription drug 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.

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.

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.

Precautions:

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

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 gram (1000 mg) daily.

Dosage And Administration:

Usual adult dose is 1 (one) softgel daily or as directed by a physician.

Notice:

Contact the moisture can discolor or erode the capsule.

How Supplied:

Prenaissance Plus is supplied in child-resistant bottles of 30 softgels (NDC# 42192-343-30). Store at 15° - 30°C (59° - 86°F) [See USP].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

* Please review the disclaimer below.