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National Drug Code (NDC) Number
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86134-001-01
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Each animal drug product electronically listed is assigned a unique 10-digit,
3-segment number. This number, known as the NDC, identifies the labeler code, product code, and package code.
The first segment, the labeler code, is assigned by the FDA. Any firm that distributes or markets the drug product is referred to as the labeler.
The second segment, the product code, identifies a specific strength, dosage form, and formulation of the product. The third segment, the package code,
identifies package sizes and types. The firm assigns both the product and package codes.
An asterisk may appear in either a product code or a package code. It merely acts as a place holder and indicates the configuration of the NDC number.
The NDC is limited to 10 digits, a firm with a 5-digit labeler code must choose between a 3-digit product code and 2-digit package code,
or 4-digit product code and 1-digit package code. A firm with a 4-digit labeler code must choose a 4-digit product code and 2-digit package code.
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Proprietary Name (Trade Name)
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GALSAFE
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The Proprietary Names used in the Electronic Animal Drug Product Listing Directory are generally supplied by the firms as required under the Act. All product names appearing in the Directory are limited to a maximum of 100 characters. Symbols indicating trademarked or registered products are omitted because of computer input capabilities. But these deletions are not intended to contradict patent, trademark, registration, or copyright laws or regulations.
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Proprietary Name (Trade Name)
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PPL657 RDNA CONSTRUCT IN DOMESTIC PIGS
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The Non Proprietary Names used in the Electronic Animal Drug Product Listing Directory are supplied by the firms as required under the Act. Non proprietary names are also known as established names.
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Ingredient List
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PPL657 RDNA CONSTRUCT IN THE GGTA1 GENE IN DOMESTIC PIGS
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Ingredient List
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Labeler Name
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REVIVICOR INC.
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The Labeler Name is the name associated with the labeler code portion of the NDC number and represents the distributor marketing the product.
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Product Type
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INTENTIONAL ANIMAL GENOMIC ALTERATION
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The Product Type refers to the general category of products being listed. For animal drugs, the following product types are available:
PRESCRIPTION ANIMAL DRUG
OTC ANIMAL DRUG
OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG
OTC TYPE B MEDICATED FEED ANIMAL DRUG
OTC TYPE C MEDICATED FEED ANIMAL DRUG
VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG
VFD TYPE B MEDICATED FEED ANIMAL DRUG
VFD TYPE C MEDICATED FEED ANIMAL DRUG
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Marketing Category
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NADA
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The Marketing Category lists whether the drug product is an approved New Animal Drug Application (NADA), an Abbreviated New Animal Drug Application (ANADA), or an Unapproved animal drug (UNAPPROVED OTHER).
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