Dexamethasone Elixir
NDC 81033-010

Dexamethasone .5 mg/5mL · Elixir (oral)
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 81033-010?
  5. Dexamethasone Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes

Product Information

Dexamethasone is a ANDA-approved product labeled by Kesin Pharma Corporation. This medication is typically used as a corticosteroid hormone receptor agonists [moa]. It is supplied as a red elixir for oral administration. This product entry covers the primary NDC 81033-010 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
81033-010
Proprietary Name:
Dexamethasone
Non-Proprietary Name: [1]
Dexamethasone
Substance Name: [2]
Dexamethasone
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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Clinical Specifications

Dosage Form:
Elixir - A clear, pleasantly flavored, sweetened hydroalcoholic liquid containing dissolved medicinal agents; it is intended for oral use.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Kesin Pharma Corporation
Labeler Code:
81033
Product Label ID:
43e2a24a-4465-5787-e063-6394a90a0b81
HCPCS Code:
J8540 - DEXAMETHASONE, ORAL, 0.25 MG
FDA Application Number: [6]
ANDA084754
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
09-21-1976
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
RED (C48326 - PINKRED)
Flavor(s):
RASPBERRY (C73413)

Code Structure Chart

Product Details

What is NDC 81033-010?

The NDC code 81033-010 is assigned by the FDA to the product Dexamethasone. This pharmaceutical product is labeled by Kesin Pharma Corporation and is currently categorized as listed product. The medication is a elixir administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 81033-010-24. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Allergic StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Atopic dermatitisBronchial asthmaContact dermatitisDrug hypersensitivity reactionsSeasonal or perennial allergic rhinitisSerum sicknessCollagen DiseasesDuring an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusAcute rheumatic carditis.Dermatologic DiseaseBullous dermatitis herpetiformisExfoliative dermatitisMycosis fungoidesPemphigusSevere erythema multiforme (Stevens-Johnson syndrome)Severe psoriasisSevere seborrheic dermatitis.Edematous StatesTo induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.Endocrine DisordersPrimary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasiaHypercalcemia associated with cancerNonsuppurative thyroiditis.Gastrointestinal diseasesTo tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis.Hematologic DisordersIdiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia.MiscellaneousDiagnostic testing of adrenocortical hyperfunctionTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis with neurologic or myocardial involvement.Neoplastic DiseasesFor palliative management of:Leukemia and lymphomas in adultsAcute leukemia of childhood.Ophthalmic DiseasesSevere acute and chronic allergic and inflammatory processes involving the eye and its adnexa, such as:Allergic conjunctivitisKeratitisAllergic corneal marginal ulcersHerpes zoster ophthalmicusIritis and iridocyclitisChorioretinitisAnterior segment inflammationDiffuse posterior uveitis and choroiditisOptic neuritisSympathetic ophthalmia.Respiratory DiseasesSymptomatic sarcoidosisLoeffler's syndrome not manageable by other meansBerylliosisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitis.Rheumatic DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis.

What are Active Ingredients of this product?

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.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Which are the Pharmacologic Classes of this product?

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.

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Product & Regulatory Definitions
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.
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".