Drug Information

Product NDC: 50970-002

Proprietary Name: e-HGH

Non Proprietary Name: hGH somatropin

Active Ingredient(s):
  • 6 [hp_C]/200mL SOMATROPIN

Administration Route(s): ORAL

Dosage Form(s): LIQUID

Pharmacy Class(es):
  • Human Growth Hormone [CS];
  • Recombinant Human Growth Hormone [EPC]

Labeler Information

Labeler Name: AnuMed International LLC
Product Type: HUMAN OTC DRUG
FDA Application Number:
Start Marketing Date:5/1/2011

Package Information

No. Package Code Package Description Billing Unit
150970-002-0130 mL in 1 BOTTLE (50970-002-01)
250970-002-0258 mL in 1 BOTTLE (50970-002-02)

NDC Record

Field Name Field Value Definition
PRODUCT NDC50970-002The 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 NAMEe-HGHThe 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 somatropinThe 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 DATE5/1/2011This 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 www.fda.gov/edrls under Structured Product Labeling Resources.
LABELER NAMEAnuMed International LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMESOMATROPINAn 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 CLASSESHuman Growth Hormone [CS], Recombinant Human Growth Hormone [EPC] 

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This page was last updated on: 4/12/2024