Neuromaquel Neuroma/anti-inflammatory System
NDC Package 70529-112-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Neuromaquel Neuroma/anti-inflammatory System 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. Marketed by It3 Medical Llc, this product is identified by NDC 70529-112 and is authorized under FDA application ANDA084916.

Identification & Billing

NDC Package Code
70529-112-01
Package Description
1 KIT in 1 PACKAGE * 10 mL in 1 VIAL, SINGLE-DOSE * 1 mL in 1 PACKET * 1 mL in 1 VIAL
Product Code
70529-112
11-Digit Billing Format
70529011201
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
Neuromaquel Neuroma/anti-inflammatory System
Dosage Form
-
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
It3 Medical Llc
FDA Application #
ANDA084916
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-01-2017
Listing Expiration
12-31-2023
Exclude Flag
I
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 70529-112-01 identifies a specific commercial package of 1 kit in 1 package * 10 ml in 1 vial, single-dose * 1 ml in 1 packet * 1 ml in 1 vial of Neuromaquel Neuroma/anti-inflammatory System, labeled by It3 Medical Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by It3 Medical Llc on March 01, 2017. The current certification is valid through December 31, 2023.

How is this It3 Medical Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70529011201. 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)
70529-112-01
11-Digit CMS (5-4-2)
70529-0112-01

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