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Drug Information

Product NDC: 17089-378

Proprietary Name: GUNA-INF GAMMA

Non Proprietary Name: INTERFERON GAMMA-1B

Active Ingredient(s):
  • 4 [hp_C]/30mL INTERFERON GAMMA-1B

Administration Route(s): ORAL

Dosage Form(s): SOLUTION/ DROPS

Pharmacy Class(es):
  • Interferon gamma [EPC];
  • Interferon-gamma [CS]

Labeler Information

Labeler Name: Guna spa
Product Type: HUMAN OTC DRUG
FDA Application Number:
Start Marketing Date:6/17/2008

Package Information

No. Package Code Package Description Billing Unit
117089-378-181 BOTTLE, DROPPER in 1 BOX (17089-378-18) / 30 mL in 1 BOTTLE, DROPPER

NDC Record

Field Name Field Value Definition
PRODUCT NDC17089-378The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates 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.
PROPRIETARY NAMEGUNA-INF GAMMAThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEINTERFERON GAMMA-1BThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMESOLUTION/ DROPSThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE6/17/2008This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEUNAPPROVED HOMEOPATHICProduct 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 under Structured Product Labeling Resources.
LABELER NAMEGuna spaName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEINTERFERON GAMMA-1BAn 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.
PHARM CLASSESInterferon gamma [EPC], Interferon-gamma [CS] 

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This page was last updated on: 2/1/2023