42769-1380 NDC - HYDROCORTISONE ()

Drug Information

  • Product NDC: 42769-1380
  • Proprietary Name: Hydrocortisone
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: Bay Pharma Inc
Product Type:
FDA Application Number: NDA016199
Marketing Category: NDA
Start Marketing Date:9/18/2008
End Marketing Date:6/30/2014

Package Information

No. Package Code Package Description Billing Unit
142769-1380-77 BOTTLE in 1 BOX (42769-1380-7) / 60 mL in 1 BOTTLE (42769-1380-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC42769-1380The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAMEHydrocortisoneThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
START MARKETING DATE9/18/2008The translation of the dosage form Code submitted by the firm.
END MARKETING DATE6/30/2014The translation of the route code submitted by the firm, indicating route of administration.
MARKETING CATEGORY NAMENDAThis is the date that the labeler indicates was the start of its marketing of the drug product.
APPLICATION NUMBERNDA016199Product 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 NAMEBay Pharma IncThis 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.

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

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