43853-0007 NDC - HGH (HGH, HEPAR BOVINUM, PITUITARY BOVINUM)

Drug Information

Product NDC: 43853-0007

Proprietary Name: HGH

Non Proprietary Name: HGH, Hepar Bovinum, Pituitary Bovinum

Active Ingredient(s):
  • 30 [hp_X]/mL SOMATROPIN;
  • 6 [hp_X]/mL BEEF LIVER;
  • 30 [hp_X]/mL BOS TAURUS PITUITARY GLAND


Administration Route(s): ORAL

Dosage Form(s): LIQUID

Labeler Information

Labeler Name: ProBLEN
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:3/6/2013
End Marketing Date:11/10/2020

Package Information

No. Package Code Package Description Billing Unit
143853-0007-130 mL in 1 BOTTLE, SPRAY (43853-0007-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC43853-0007The 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 NAMEHGHThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEHGH, Hepar Bovinum, Pituitary BovinumThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMELIQUIDThe 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 DATE3/6/2013This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE11/10/2020This 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.
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 www.fda.gov/edrls under Structured Product Labeling Resources.
LABELER NAMEProBLENName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMESOMATROPIN; BEEF LIVER; BOS TAURUS PITUITARY GLANDThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH30; 6; 30 
ACTIVE INGRED UNIT[hp_X]/mL; [hp_X]/mL; [hp_X]/mL 

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This page was last updated on: 12/20/2019