Dexamethasone Sodium Phosphate Injection, Solution
NDC Package 81565-202-02

11-digit billing NDC: 81565020202 · Billing unit: ML · 25 ML per package

Package Information

Dexamethasone Sodium Phosphate injection is 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. This formulation utilizes a injection, solution delivery system. Marketed by Phlow Corporation, this product is identified by NDC 81565-202 and is authorized under FDA application ANDA084916.

Identification & Billing

NDC Package Code
81565-202-02
Package Description
25 VIAL in 1 TRAY / 1 mL in 1 VIAL (81565-202-01)
Product Code
11-Digit Billing Format
81565020202
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
25 ML
RxNorm Crosswalk
  • RxCUI: 1812194 - dexAMETHasone sodium phosphate 4 MG in 1 ML Injection
  • RxCUI: 1812194 - 1 ML dexamethasone phosphate 4 MG/ML Injection
  • RxCUI: 1812194 - dexamethasone sodium phosphate 4 MG (as dexamethasone sodium phosphate 4.4 MG) per 1 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
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
Usage Information
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.

Regulatory & Marketing

Labeler Name
Phlow Corporation
Product Type
Human Prescription Drug
FDA Application #
ANDA084916
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-15-2021
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.

Source: ASP
Dexamethasone sodium phos
HCPCS Dosage 1 MG
Units / Pkg 100

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 81565-202-02 identifies a specific commercial package of 25 vial in 1 tray / 1 ml in 1 vial (81565-202-01) of Dexamethasone Sodium Phosphate, a human prescription drug labeled by Phlow Corporation. This injection, solution is formulated for intramuscular; intravenous 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 Phlow Corporation on December 15, 2021. The current certification is valid through December 31, 2027.

How is this Phlow Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81565020202. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 25 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)
81565-202-02
11-Digit CMS (5-4-2)
81565-0202-02

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