54505-332 NDC - HYDROCORTISONE ()

Drug Information

  • Product NDC: 54505-332
  • Proprietary Name: HYDROCORTISONE
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: Lineage Therapeutics Inc
Product Type:
FDA Application Number: ANDA040646
Marketing Category: ANDA
Start Marketing Date:3/30/2007
End Marketing Date:11/30/2019

Package Information

No. Package Code Package Description Billing Unit
154505-332-10100 TABLET in 1 BOTTLE, PLASTIC (54505-332-10)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC54505-332This is the date that the labeler indicates was the start of its marketing of the drug product.
PROPRIETARY NAMEHYDROCORTISONEName of Company corresponding to the labeler code segment of the Product NDC.
START MARKETING DATE3/30/2007An 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.
END MARKETING DATE11/30/2019 
MARKETING CATEGORY NAMEANDAProduct 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.
APPLICATION NUMBERANDA040646This 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.
LABELER NAMELineage Therapeutics IncName of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 12/6/2025

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