82797-130 NDC - ANDROTONE SYRUP (TRIBULUS TERR, AVENA SATIVA,STERCULIA ACUM, NUPHAR LUT, SABAL SERR, AGNUS CAST, LYCOPODIUM CLAV, GENTIANA LUT, YOHIMBINUM, LECITHIN, NATRUM PHOS, KALI PHOS, CALCAREA PHOS, NATRUM MUR, STRYCHNINUM SULPH, ACIDUM PHOS, CHOLOFORMUM)

Drug Information

  • Product NDC: 82797-130
  • Proprietary Name: Androtone syrup
  • Non Proprietary Name: Tribulus terr, Avena sativa,Sterculia acum, Nuphar Lut, Sabal serr, Agnus cast, Lycopodium clav, Gentiana lut, Yohimbinum, Lecithin, Natrum phos, Kali phos, Calcarea phos, Natrum mur, Strychninum sulph, Acidum phos, Choloformum
  • Active Ingredient(s): .08 mg/120mL AVENA SATIVA WHOLE; .005 mg/120mL CALCIUM PHOSPHATE; .03 mg/120mL COLA ACUMINATA WHOLE; .01 mg/120mL GENTIANA LUTEA WHOLE; .0625 mg/120mL LECITHIN, SOYBEAN; .01 mg/120mL LYCOPODIUM CLAVATUM WHOLE; .005 mg/120mL MONOBASIC POTASSIUM PHOSPHATE; .03 mg/120mL NUPHAR LUTEA WHOLE; .01 mg/120mL PHOSPHORIC ACID; .03 mg/120mL SABAL PALMETTO WHOLE; .005 mg/120mL SODIUM CHLORIDE; .005 mg/120mL SODIUM PHOSPHATE; .015 mg/120mL STRYCHNINE; .08 mg/120mL TRIBULUS TERRESTRIS WHOLE; .02 mg/120mL VITEX AGNUS-CASTUS WHOLE; .01 mg/120mL YOHIMBINE
  • Administration Route(s): ORAL
  • Dosage Form(s): SYRUP
  • Pharmacy Class(es): Blood Coagulation Factor [EPC]; Calcium [CS]; Cations; Divalent [CS]; Increased Coagulation Factor Activity [PE]; Increased Large Intestinal Motility [PE]; Increased Large Intestinal Motility [PE]; Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]; Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]; Osmotic Activity [MoA]; Osmotic Activity [MoA]; Osmotic Laxative [EPC]; Osmotic Laxative [EPC]; Phosphate Binder [EPC]; Phosphate Chelating Activity [MoA]; Potassium Compounds [CS]; Potassium Salt [EPC]

Labeler Information

Field Name Field Value
Labeler Name: Dr. Masood Homeopathic Pharmaceuticals Private Limited
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:7/8/2024

Package Information

No. Package Code Package Description Billing Unit
182797-130-12120 mL in 1 BOTTLE, PLASTIC (82797-130-12)

NDC Record

Field Name Field Value Definition
PRODUCT NDC82797-130The 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 NAMEAndrotone syrupThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMETribulus terr, Avena sativa,Sterculia acum, Nuphar Lut, Sabal serr, Agnus cast, Lycopodium clav, Gentiana lut, Yohimbinum, Lecithin, Natrum phos, Kali phos, Calcarea phos, Natrum mur, Strychninum sulph, Acidum phos, CholoformumThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMESYRUPThe 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 DATE7/8/2024This 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 NAMEDr. Masood Homeopathic Pharmaceuticals Private LimitedName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEAVENA SATIVA WHOLE; CALCIUM PHOSPHATE; COLA ACUMINATA WHOLE; GENTIANA LUTEA WHOLE; LECITHIN, SOYBEAN; LYCOPODIUM CLAVATUM WHOLE; MONOBASIC POTASSIUM PHOSPHATE; NUPHAR LUTEA WHOLE; PHOSPHORIC ACID; SABAL PALMETTO WHOLE; SODIUM CHLORIDE; SODIUM PHOSPHATE; STRYCHNINE; TRIBULUS TERRESTRIS WHOLE; VITEX AGNUS-CASTUS WHOLE; YOHIMBINEAn 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.
ACTIVE NUMERATOR STRENGTH.08; .005; .03; .01; .0625; .01; .005; .03; .01; .03; .005; .005; .015; .08; .02; .01 
ACTIVE INGRED UNITmg/120mL; mg/120mL; mg/120mL; mg/120mL; mg/120mL; mg/120mL; mg/120mL; mg/120mL; mg/120mL; mg/120mL; mg/120mL; mg/120mL; mg/120mL; mg/120mL; mg/120mL; mg/120mL 
PHARM CLASSESBlood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC] 

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This page was last updated on: 7/4/2025

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