NDC 73317-8286 Neonatal Complete

Vitamin C, Calcium, Iron, Vitamin D3, Vitamin E, Thiamin, Riboflavin, Niacinamide, Vitamin B6, Folic Acid, Iodine, Zinc, Copper, Docusate Sodium

NDC Product Code 73317-8286

NDC CODE: 73317-8286

Proprietary Name: Neonatal Complete 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: Vitamin C, Calcium, Iron, Vitamin D3, Vitamin E, Thiamin, Riboflavin, Niacinamide, Vitamin B6, Folic Acid, Iodine, Zinc, Copper, Docusate Sodium 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):
WHITE (C48325)
Shape: CAPSULE (C48336)
Size(s):
6 MM
Score: 1

NDC Code Structure

  • 73317 - Slv Pharmaceuticals Llc Dba Aum Pharmaceuticals

NDC 73317-8286-1

Package Description: 100 TABLET in 1 BOTTLE

NDC Product Information

Neonatal Complete with NDC 73317-8286 is a a human prescription drug product labeled by Slv Pharmaceuticals Llc Dba Aum Pharmaceuticals. The generic name of Neonatal Complete is vitamin c, calcium, iron, vitamin d3, vitamin e, thiamin, riboflavin, niacinamide, vitamin b6, folic acid, iodine, zinc, copper, docusate sodium. The product's dosage form is tablet and is administered via oral form.

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

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.

Neonatal Complete 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.


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.

  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
  • TALC (UNII: 7SEV7J4R1U)

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]
  • Vitamin B 12 - [CS]
  • Vitamin B12 - [EPC] (Established Pharmacologic Class)
  • Blood Coagulation Factor - [EPC] (Established Pharmacologic Class)
  • Increased Coagulation Factor Activity - [PE] (Physiologic Effect)
  • Calcium - [CS]
  • Cations -
  • Divalent - [CS]
  • Copper Absorption Inhibitor - [EPC] (Established Pharmacologic Class)
  • Decreased Copper Ion Absorption - [PE] (Physiologic Effect)
  • Calculi Dissolution Agent - [EPC] (Established Pharmacologic Class)
  • Magnesium Ion Exchange Activity - [MoA] (Mechanism of Action)
  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Osmotic Activity - [MoA] (Mechanism of Action)
  • Inhibition Small Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Stimulation Large Intestine Fluid/Electrolyte Secretion - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Vitamin C - [EPC] (Established Pharmacologic Class)
  • Ascorbic Acid - [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: Slv Pharmaceuticals Llc Dba Aum Pharmaceuticals
Labeler Code: 73317
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: 09-15-2020 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Neonatal Complete Product Label Images

Neonatal Complete 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

Description

Each tablet contains:VITAMIN A (AS  BETA CAROTENE)1200 MCGVITAMIN C (ASCORBIC ACID)120 MGVITAMIN D3 (AS CHOLECALCIFEROL)25 MCGVITAMIN E (AS DL-ALPHA TOCOPHEROL ACETATE)18.4 MGVITAMIN B1 (AS THIAMINE MONONITRATE)3 MGVITAMIN B2 (AS RIBOFLAVIN)3 MGVITAMIN B3 (AS NIACINAMIDE)20 MGVITAMIN B6 (AS PYRIDOXINE HCL)3 MGFOLIC ACID1000 MCGVITAMIN B12 (AS CYANOCOBALAMIN)8 MCGCALCIUM (AS CALCIUM CARBONATE)200 MGIRON (AS FERROUS FUMARATE)29 MGZINC (AS ZINC OXIDE)15 MGCOPPER (AS CUPRIX OXIDE)3 MGBIOTIN30 MCGPANTOTHENIC ACID (AS CALCIUM-D- PANTOTHENATE7 MGMAGNESIUM (AS MAGNESIUM OXIDE)100 MGIODINE (AS POTASSIUM IODIDE )150 MCGOther Ingredients: microcrystalline cellulose, stearic acid, croscarmellose sodium, silicon dioxide, magnesium stearate, HPMC E15, HPMC E5/E6,titanium dioxide,PEG-8000, Talc.

Indications

NEONATAL Complete is a multi-vitamin/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 per day has been shown to have potential antithrombotic effects,
including an increased bleeding time and INR. Administration of omega-3
fatty acids should be avoided in patients on anticoagulants and in
those known to have an inherited or acquired bleeding diathesis.WARNING: Folic acid
alone is improper therapy in the treatment of pernicious anemia and
other megaloblastic anemias where vitamin B





12 is deficient.

Precautions

Folic acid in doses above 0.1 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.

Dosage And Administration

One tablet and one capsule daily or as directed by a physician.

Storage

Store at 15°C to 30°C (69°F to 86°F). [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container.NOTICE: Contact with moisture may produce surface discoloration or erosion of tablet.

How Supplied

100 Prenatal Vitamin Tablets  - NDC 73317-8286-1.To report a serious adverse event or obtain product information, call 1-866-760-6565.Please consult your health care provider with any dietary concerns.Call your licensed medical practitioner about side effect.Manufactured for and Distributed by:AUM Pharmaceuticals Hauppauge, NY 11788.Made in USA

* Please review the disclaimer below.