62068-314 NDC - HOMATROPINE METHYLBROMIDE

Drug Information

  • Product NDC: 62068-314
  • Proprietary Name:
  • Non Proprietary Name: Homatropine Methylbromide
  • Active Ingredient(s): 1 kg/kg HOMATROPINE METHYLBROMIDE
  • Administration Route(s):
  • Dosage Form(s): POWDER

Labeler Information

Field Name Field Value
Labeler Name: Hubei Biocause Heilen Pharmaceutical Co., Ltd
Product Type: BULK INGREDIENT
FDA Application Number:
Marketing Category: BULK INGREDIENT
Start Marketing Date:10/20/2010

Package Information

No. Package Code Package Description Billing Unit
162068-314-0116 kg in 1 DRUM (62068-314-01)

NDC Record

Field Name Field Value Definition
PRODUCT NDC62068-314The 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 NAMEBULK INGREDIENTThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEHomatropine MethylbromideThis is the date that the labeler indicates was the start of its marketing of the drug product.
DOSAGE FORM NAMEPOWDERProduct 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.
START MARKETING DATE10/20/2010This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
MARKETING CATEGORY NAMEBULK INGREDIENTName of Company corresponding to the labeler code segment of the Product NDC.
LABELER NAMEHubei Biocause Heilen Pharmaceutical Co., LtdName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEHOMATROPINE METHYLBROMIDEAn 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 STRENGTH1 
ACTIVE INGRED UNITkg/kg 

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This page was last updated on: 4/14/2026

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