Biotitum Pellet
NDC 63545-635
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Biotitum is a UNAPPROVED HOMEOPATHIC-approved product labeled by Hahnemann Laboratories, Inc.. Biotin (vitamin B7) is used to prevent or treat low levels of vitamin B7 in people who do not get enough of the vitamin from their diets. It is supplied as a white pellet for oral administration. This product entry covers the primary NDC 63545-635 and 4 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
63545-635
Proprietary Name:
Biotitum
Non-Proprietary Name: [1]
Biotitum
Substance Name: [2]
Biotin
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Pellet
- A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
63545
Product Label ID:
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Marketing Timeline
Start Marketing Date: [9]
05-09-2022
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Product Characteristics
Color(s):
WHITE (C48325)
Shape:
ROUND (C48348)
Size(s):
3 MM
2 MM
2 MM
Score:
1
Code Structure Chart
Product Details
What is NDC 63545-635?
The NDC code 63545-635 is assigned by the FDA to the product Biotitum. This pharmaceutical product is labeled by Hahnemann Laboratories, Inc. and is currently categorized as listed product. The medication is a pellet administered via oral route. In terms of distribution, this product is available in 4 different package configurations. The associated package NDC(s) include: 63545-635-01, 63545-635-02, 63545-635-03, 63545-635-04. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
Biotin (vitamin B7) is used to prevent or treat low levels of vitamin B7 in people who do not get enough of the vitamin from their diets. Most people who eat a normal diet do not need extra vitamin B7. However, some conditions (such as pregnancy, parenteral nutrition, rapid weight loss) can cause low levels of vitamin B7.
What are Active Ingredients of this product?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
- BIOTIN 500 [hp_C]/1 - A water-soluble, enzyme co-factor present in minute amounts in every living cell. It occurs mainly bound to proteins or polypeptides and is abundant in liver, kidney, pancreas, yeast, and milk.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- BIOTIN (UNII: 6SO6U10H04)
- BIOTIN (UNII: 6SO6U10H04) (Active Moiety)
Which are the Inactive Ingredients associated UNII Codes?
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. The UNII codes for the inactive ingredients in this product are:
- SUCROSE (UNII: C151H8M554)
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Product & Regulatory Definitions
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.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
