Dexamethasone Sodium Phosphate Injection, Solution
NDC 85766-269

Dexamethasone Sodium Phosphate 4 mg/mL · Injection, Solution (intramuscular; intravenous)

Product Information

Dexamethasone Sodium Phosphate is a ANDA-approved product labeled by Sportpharm Llc. This medication is typically used as a corticosteroid hormone receptor agonists [moa]. It is supplied as a injection, solution for intramuscular; intravenous administration. This product entry covers the primary NDC 85766-269 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
85766-269
Proprietary Name:
Dexamethasone Sodium Phosphate
Non-Proprietary Name: [1]
Dexamethasone Sodium Phosphate
Substance Name: [2]
Dexamethasone Sodium Phosphate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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Clinical Specifications

Dosage Form:
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route(s): [4]
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.

Labeler & Regulatory Data

Labeler Name: [5]
Labeler Code:
85766
FDA Application Number: [6]
ANDA084916
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
09-07-2000
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 85766-269?

The NDC code 85766-269 is assigned by the FDA to the product Dexamethasone Sodium Phosphate. This pharmaceutical product is labeled by Sportpharm Llc and is currently categorized as listed product. The medication is a injection, solution administered via intramuscular; intravenous route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 85766-269-30. 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?

Intravenous or Intramuscular InjectionWhen oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, those products labeled for intravenous or intramuscular use are indicated as follows:• Endocrine Disorders   Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid    supplementation is of particular importance)   Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used)   Preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful   Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected   Congenital adrenal hyperplasia   Nonsuppurative thyroiditis   Hypercalcemia associated with cancer• Rheumatic Disorders   As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:   Post-traumatic osteoarthritis   Synovitis of osteoarthritis   Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)   Acute and subacute bursitis   Epicondylitis   Acute nonspecific tenosynovitis   Acute gouty arthritis   Psoriatic arthritis   Ankylosing spondylitis• Collagen Diseases   During an exacerbation or as maintenance therapy in selected cases of:   Systemic lupus erythematosus   Acute rheumatic carditis• Dermatologic Diseases   Pemphigus   Severe erythema multiforme (Stevens-Johnson syndrome)   Exfoliative dermatitis   Bullous dermatitis herpetiformis   Severe seborrheic dermatitis   Severe psoriasis   Mycosis fungoides• Allergic States   Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in:   Bronchial asthma   Contact dermatitis   Atopic dermatitis   Serum sickness   Seasonal or perennial allergic rhinitis   Drug hypersensitivity reactions   Urticarial transfusion reactions   Acute noninfectious laryngeal edema (epinephrine is the drug of first choice)• Ophthalmic Diseases   Severe acute and chronic allergic and inflammatory processes involving the eye, such as:   Herpes zoster ophthalmicus   Iritis, iridocyclitis   Chorioretinitis   Diffuse posterior uveitis and choroiditis   Optic neuritis   Sympathetic ophthalmia   Anterior segment inflammation   Allergic conjunctivitis   Keratitis   Allergic corneal marginal ulcers• Gastrointestinal Diseases   To tide the patient over a critical period of the disease in:   Ulcerative colitis (Systemic therapy)   Regional enteritis (Systemic therapy)• Respiratory Diseases   Symptomatic sarcoidosis   Berylliosis   Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy Loeffler’s syndrome not manageable by other means   Aspiration pneumonitis• Hematologic Disorders   Acquired (autoimmune) hemolytic anemia     Idiopathic thrombocytopenic purpura in adults (IV only; IM administration is contraindicated)    Secondary thrombocytopenia in adults   Erythroblastopenia (RBC anemia)   Congenital (erythroid) hypoplastic anemia• Neoplastic Diseases   For palliative management of:   Leukemias and lymphomas in adults   Acute leukemia of childhood• Edematous States   To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type, or that due to lupus erythematosus• Miscellaneous   Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy   Trichinosis with neurologic or myocardial involvement• Diagnostic testing of adrenocortical hyperfunction• Cerebral Edema associated with primary or metastatic brain tumor, craniotomy, or head injury.   Use in cerebral edema is not a substitute for careful neurosurgical evaluation and definitive management such as neurosurgery or other specific therapy.

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:
  • RxCUI: 1116927 - dexAMETHasone sodium phosphate 4 MG/ML (dexAMETHasone phosphate equivalent) Injectable Solution
  • RxCUI: 1116927 - dexamethasone phosphate 4 MG/ML Injectable Solution
  • RxCUI: 1116927 - dexamethasone phosphate 4 MG/ML (as dexamethasone sodium phosphate 4.4 MG/ML) Injectable Solution

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".