Biopar Delta-forte
NDC 64661-793

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 64661-793?
  5. Biopar Delta-forte Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Biopar Delta-forte is a UNAPPROVED DRUG OTHER-approved product labeled by Jaymac Pharma. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a brown product. This product entry covers the primary NDC 64661-793 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
64661-793
Proprietary Name:
Biopar Delta-forte
Product Type: [3]
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Jaymac Pharma
Labeler Code:
64661
Product Label ID:
ce7d1f45-0e38-48c5-abf6-b229c6b2e9b3
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.

Marketing Timeline

Start Marketing Date: [9]
06-01-2024
End Marketing Date: [10]
12-08-2025
Listing Expiration Date: [11]
12-08-2025
Exclude Flag: [12]
D

Product Characteristics

Color(s):
BROWN (C48332 - ORANGISH-BROWN)
Shape:
OVAL (C48345)
Size(s):
16 MM
Imprint(s):
7N3
Score:
1

Code Structure Chart

Product Details

What is NDC 64661-793?

The NDC code 64661-793 is assigned by the FDA to the product Biopar Delta-forte. This pharmaceutical product is labeled by Jaymac Pharma and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 64661-793-30. 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?

   BioparTMdelta-FORTE is indicated in the treatment of pernicious anemia and the prevention of folate deficiency;   BioparTM delta-FORTE is specifically indicated as a primary and adjunctive treatment in pernicious anemia patients having idiosyncrasy or sensitivity to parenteral administration - or when parental therapy is refused;   BioparTM delta-FORTE is further indicated in the maintenance of normal hematologic status (hematopoiesis) in macrocytic anemia conditions which are caused by either cobalamin and/or folate deficiency, and where increased intrinsic factor is desired - including:      1. Malabsorption of cobalamin resulting from structural or functional damage to the stomach - where intrinsic factor is secreted, or to the ileum, where intrinsic factor facilitates cobalamin absorption. Folate deficiency in these patients is usually more severe than cobalamin deficiency;      2. Genetic polymorphisms such as MTHFR that impede folate metabolism and the effective use of synthetic folic acid (oxidized form); and      3. Inadequate secretion of intrinsic factor, resulting from lesions that destroy the gastric mucosa (ingestion of corrosives, extensive neoplasia), and a number of conditions associated with a variable degree of gastric atrophy (certain endocrine disorders, iron deficiency, and subtotal gastrectomy). Total gastrectomy always produces cobalamin deficiency. Structural lesions leading to cobalamin deficiency include regional ileitis, ileal resections, malignancies, etc

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

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:

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Product & Regulatory Definitions
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 End Marketing Date? 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.
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".