Dexamethasone Sodium Phosphate Injection, Solution
NDC Package 67457-484-30

11-digit billing NDC: 67457048430 · Billing unit: ML · 750 ML per package
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Dexamethasone Sodium Phosphate injection is a. This formulation utilizes a injection, solution delivery system. Marketed by Mylan Institutional Llc, this product is identified by NDC 67457-484 and is authorized under FDA application ANDA040803.

Identification & Billing

NDC Package Code
67457-484-30
Package Description
25 VIAL in 1 CARTON / 30 mL in 1 VIAL (67457-484-00)
Product Code
67457-484
11-Digit Billing Format
67457048430
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
750 ML
RxNorm Crosswalk
  • 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
  • RxCUI: 1812194 - dexAMETHasone sodium phosphate 4 MG in 1 ML Injection
  • RxCUI: 1812194 - 1 ML dexamethasone phosphate 4 MG/ML Injection

Clinical Specifications

Proprietary Name
Dexamethasone Sodium Phosphate
Non-Proprietary Name
Dexamethasone Sodium Phosphate
Substance Name
Dexamethasone Sodium Phosphate
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
  • Intra-articular - Administration within a joint.
  • Intralesional - Administration within or introduced directly into a localized lesion.
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
  • Soft Tissue - Administration into any soft tissue.
Active Ingredient(s)
DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL
Pharmacologic Class
Usage Information
A. 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 cancer.2. 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.3. Collagen Diseases:During an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosus.Acute rheumatic carditis.4. 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 anemia.10. Neoplastic Diseases:For palliative management of:Leukemias and lymphomas in adults.Acute leukemia of childhood.11. 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: Tuberculosis 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.B. By intra-articular or soft tissue injection:As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Synovitis of osteoarthritis.Rheumatoid arthritis.Acute and subacute bursitis.Acute gouty arthritis.Epicondylitis.Acute nonspecific tenosynovitis.Post-traumatic osteoarthritis.C. By intralesional injection:Keloids.Localized hypertrophic, infiltrated, inflammatory lesions of: lichen planus, psoriatic plaques, granuloma annulare, and lichen simplex chronicus (neurodermatitis).Discoid lupus erythematosus.Necrobiosis lipoidica diabeticorum.Alopecia areata.May also be useful in cystic tumors of an aponeurosis or tendon (ganglia).

Regulatory & Marketing

Labeler Name
Mylan Institutional Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA040803
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-15-2020
Listing Expiration
12-31-2027
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J1100
Source: ASP
Dexamethasone sodium phos
HCPCS Dosage 1 MG
Units / Pkg 3000

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 67457-484-30 identifies a specific commercial package of 25 vial in 1 carton / 30 ml in 1 vial (67457-484-00) of Dexamethasone Sodium Phosphate, a human prescription drug labeled by Mylan Institutional Llc. This injection, solution is formulated for intra-articular; intralesional; intramuscular; intravenous; soft tissue use and contains dexamethasone sodium phosphate 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 Mylan Institutional Llc on April 15, 2020. The current certification is valid through December 31, 2027.

How is this Mylan Institutional Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67457048430. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 750 total billable units per package. 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)
67457-484-30
11-Digit CMS (5-4-2)
67457-0484-30

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