Mardex 25 Kit
NDC 76420-810

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 76420-810?
  4. Mardex 25 Kit Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

Mardex 25 Kit (dexamethasone sodium phosphate, bupivacaine hydrochloride, povidine iodine) is a UNAPPROVED DRUG OTHER-approved product labeled by Asclemed Usa, Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a kit for epidural; infiltration; intramuscular; intravenous; topical administration. This product entry covers the primary NDC 76420-810 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
76420-810
Proprietary Name:
Mardex 25 Kit
Non-Proprietary Name: [1]
Dexamethasone Sodium Phosphate, Bupivacaine Hydrochloride, Povidine Iodine
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Kit - A packaged collection of related material.
Administration Route(s): [4]
  • Epidural - Administration upon or over the dura mater.
  • Infiltration - Administration that results in substances passing into tissue spaces or into cells.
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
  • 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 & Regulatory Data

Labeler Name: [5]
Asclemed Usa, Inc.
Labeler Code:
76420
Product Label ID:
94472ddb-ae1d-4a11-a673-81254d562e6b
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.

Marketing Timeline

Start Marketing Date: [9]
08-21-2014
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 76420-810?

The NDC code 76420-810 is assigned by the FDA to the product Mardex 25 Kit. It is commonly known by its generic name, dexamethasone sodium phosphate, bupivacaine hydrochloride, povidine iodine. This pharmaceutical product is labeled by Asclemed Usa, Inc. and is currently categorized as listed product. The medication is a kit administered via epidural; infiltration; intramuscular; intravenous; topical route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 76420-810-01. 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?

By intravenous or intramuscular injection when oral therapy is not feasible:1. 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 cancer2. 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 spondylitis3. Collagen Diseases     During an exacerbation or as maintenance therapy in selected cases of:     Systemic lupus erythematosus     Acute rheumatic carditis4. Dermatologic Diseases     Pemphigus     Severe erythema multiforme (Stevens-Johnson syndrome)     Exfoliative dermatitis     Bullous dermatitis herpetiformis     Severe seborrheic dermatitis     Severe psoriasis     Mycosis fungoides 5. 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).6. 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 7. Gastrointestinal Diseases     To tide the patient over a critical period of the disease in:     Ulcerative colitis (systemic therapy)     Regional enteritis (systemic therapy)8. 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 9. 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 anemia10. Neoplastic Diseases     For palliative management of:     Leukemias and lymphomas in adults     Acute leukemia of childhood11. 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.12. Miscellaneous     Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.     Trichinosis with neurologic or myocardial involvement.13. Diagnostic testing of adrenocortical hyperfunction.14. 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.   MARCAINE is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia. (See WARNINGS.)Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of 0.75% concentration of MARCAINE in these patients.MARCAINE is not recommended for intravenous regional anesthesia (Bier Block). See WARNINGS.The routes of administration and indicated MARCAINE concentrations are:∙ local infiltration                                                                                 0.25%∙ peripheral nerve block                                                                      0.25% and 0.5%∙ retrobulbar block                                                                              0.75%∙ sympathetic block                                                                             0.25%∙ lumbar epidural                                                                                 0.25%, 0.5%, and 0.75%                                                                                                          (0.75% not for obstetrical anesthesia)∙ caudal                                                                                               0.25% and 0.5%∙ epidural test dose                                                                              0.5% with epinephrine 1:200,000∙ dental blocks                                                                                     0.5% with epinephrine 1:200,000(See DOSAGE AND ADMINISTRATION for additional information.)Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of MARCAINE.

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:

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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 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 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".