Dexamethasone Elixir
NDC Package 10135-795-71

11-digit billing NDC: 10135079571
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Dexamethasone elixirs is allergic StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Atopic dermatitis, Bronchial asthma, Contact dermatitis, Drug hypersensitivity reactions, Seasonal or perennial allergic rhinitis, and Serum sickness. This formulation utilizes a elixir delivery system. Marketed by Marlex Pharmaceuticals, Inc, this product is identified by NDC 10135-795 and is authorized under FDA application ANDA084754.

Identification & Billing

NDC Package Code
10135-795-71
Package Description
237 mL in 1 BOTTLE, GLASS
Product Code
10135-795
11-Digit Billing Format
10135079571
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dexamethasone
Non-Proprietary Name
Dexamethasone
Substance Name
Dexamethasone
Dosage Form
Elixir - A clear, pleasantly flavored, sweetened hydroalcoholic liquid containing dissolved medicinal agents; it is intended for oral use.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DEXAMETHASONE .5 mg/5mL
Pharmacologic Class
Usage Information
Allergic StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Atopic dermatitis, Bronchial asthma, Contact dermatitis, Drug hypersensitivity reactions, Seasonal or perennial allergic rhinitis, and Serum sickness. Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus, and Acute rheumatic carditis. Dermatologic DiseasesBullous dermatitis herpetiformis, Exfoliative dermatitis, Mycosis fungoides, Pemphigus, Severe erythema multiforme (Stevens-Johnson syndrome), Severe psoriasis, and Severe 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 hyperplasia, Hypercalcemia associated with cancer, and Nonsuppurative thyroiditis. Gastrointestinal diseasesTo tide the patient over a critical period of the disease in: Ulcerative colitis, and Regional enteritis. Hematologic DisordersIdiopathic thrombocytopenic purpura in adults, Secondary thrombocytopenia in adults, Acquired (autoimmune) hemolytic anemia, Erythroblastopenia (RBC anemia), and Congenital (erythroid) hypoplastic anemia. MiscellaneousDiagnostic testing of adrenocortical hyperfunction, Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy, and Trichinosis with neurologic or myocardial involvement. Neoplastic DiseasesFor palliative management of: Leukemia and lymphomas in adults, and Acute leukemia of childhood. Ophthalmic DiseasesSevere acute and chronic allergic and inflammatory processes involving the eye and its adnexa, such as: Allergic conjunctivitis, Keratitis, Allergic corneal marginal ulcers, Herpes zoster ophthalmicus, Iritis and iridocyclitis, Chorioretinitis, Anterior segment inflammation, Diffuse posterior uveitis and choroiditis, Optic neuritis, and Sympathetic ophthalmia. Respiratory DiseasesSymptomatic sarcoidosis, Loeffler's syndrome not manageable by other means, Berylliosis, Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, and Aspiration pneumonitis. Rheumatic DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis, Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), Ankylosing spondylitis, Acute and subacute bursitis, Acute nonspecific tenosynovitis, Acute gouty arthritis, Post-traumatic osteoarthritis, Synovitis of osteoarthritis, and Epicondylitis.

Regulatory & Marketing

Labeler Name
Marlex Pharmaceuticals, Inc
Product Type
Human Prescription Drug
FDA Application #
ANDA084754
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-21-1976
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 10135-795-71 identifies a specific commercial package of 237 ml in 1 bottle, glass of Dexamethasone, a human prescription drug labeled by Marlex Pharmaceuticals, Inc. This elixir is formulated for oral use and contains dexamethasone as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Marlex Pharmaceuticals, Inc on September 21, 1976. The current certification is valid through December 31, 2026.

How is this Marlex Pharmaceuticals, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10135079571. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
10135-795-71
11-Digit CMS (5-4-2)
10135-0795-71

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.