NDC 72934-2113 Hydrocortisone 2.5% / Levocetirizine Dihydrochloride 2%

Hydrocortisone 2.5% / Levocetirizine Dihydrochloride 2%

NDC Product Code 72934-2113

NDC Code: 72934-2113

Proprietary Name: Hydrocortisone 2.5% / Levocetirizine Dihydrochloride 2% What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Hydrocortisone 2.5% / Levocetirizine Dihydrochloride 2% What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 72934 - Sincerus Florida, Llc
    • 72934-2113 - Hydrocortisone 2.5% / Levocetirizine Dihydrochloride 2%

NDC 72934-2113-2

Package Description: 30 g in 1 BOTTLE, PUMP

NDC Product Information

Hydrocortisone 2.5% / Levocetirizine Dihydrochloride 2% with NDC 72934-2113 is a a human prescription drug product labeled by Sincerus Florida, Llc. The generic name of Hydrocortisone 2.5% / Levocetirizine Dihydrochloride 2% is hydrocortisone 2.5% / levocetirizine dihydrochloride 2%. The product's dosage form is cream and is administered via topical form.

Labeler Name: Sincerus Florida, Llc

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Hydrocortisone 2.5% / Levocetirizine Dihydrochloride 2% 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.

  • HYDROCORTISONE 2.5 g/100g
  • LEVOCETIRIZINE DIHYDROCHLORIDE 2 g/100g

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

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)
  • Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Sincerus Florida, Llc
Labeler Code: 72934
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: 05-15-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Hydrocortisone 2.5% / Levocetirizine Dihydrochloride 2% Product Label Images

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