NDC 0003-0249 Halog

Halcinonide Solution Topical - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0003-0249
Proprietary Name:
Halog
Non-Proprietary Name: [1]
Halcinonide
Substance Name: [2]
Halcinonide
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s): [4]
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Labeler Name: [5]
    E.r. Squibb & Sons, L.l.c.
    Labeler Code:
    0003
    FDA Application Number: [6]
    NDA017823
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    01-01-2009
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Packages

    NDC Code 0003-0249-15

    Package Description: 20 mL in 1 BOTTLE, PLASTIC

    NDC Code 0003-0249-20

    Package Description: 60 mL in 1 BOTTLE, PLASTIC

    Product Details

    What is NDC 0003-0249?

    The NDC code 0003-0249 is assigned by the FDA to the product Halog which is a human prescription drug product labeled by E.r. Squibb & Sons, L.l.c.. The generic name of Halog is halcinonide. The product's dosage form is solution and is administered via topical form. The product is distributed in 2 packages with assigned NDC codes 0003-0249-15 20 ml in 1 bottle, plastic , 0003-0249-20 60 ml in 1 bottle, plastic . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Halog?

    This medication is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). Halcinonide reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a strong corticosteroid.

    What are Halog Active Ingredients?

    An 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.
    • HALCINONIDE 1 mg/mL - A glucocorticoid used topically in the treatment of DERMATITIS; ECZEMA; or PSORIASIS. It may cause skin irritation.

    Which are the Pharmacologic Classes for Halog?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Product Footnotes

    [1] 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.

    [2] What is the Substance Name? - An 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.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

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

    [6] What is the FDA Application Number? - This 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.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [12] 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".