Hydrocortisoneacetatesuppository with NDC 24689-103 is a a human prescription drug product labeled by Apnar Pharma Lp. The generic name of Hydrocortisoneacetatesuppository is hydrocortisone acetate suppository. The product's dosage form is suppository and is administered via rectal form.
Dosage Form: Suppository - A solid body of various weights and shapes, adapted for introduction into the rectal orifice of the human body; they usually melt, soften, or dissolve at body temperature.
Product Type: Human Prescription Drug What kind of product is this?
Indicates 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.
Hydrocortisoneacetatesuppository Active Ingredient(s) What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
- Rectal - Administration to the rectum.
Pharmacological Class(es) What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.
- Corticosteroid - [EPC] (Established Pharmacologic Class)
- Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Labeler Name: Apnar Pharma Lp
Labeler Code: 24689
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product 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 Date: 10-01-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
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