NDC 70529-118 Cortaren Corticosteroid/anti-inflammatory System

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
70529-118
Proprietary Name:
Cortaren Corticosteroid/anti-inflammatory System
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Labeler Code:
70529
Start Marketing Date: [9]
03-01-2017
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I
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Product Details

What is NDC 70529-118?

The NDC code 70529-118 is assigned by the FDA to the product Cortaren Corticosteroid/anti-inflammatory System which is product labeled by It3 Medical Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 70529-118-01 1 kit in 1 package * 10 ml in 1 vial, single-dose * 1 ml in 1 vial, single-dose * 1 ml in 1 packet * 1 ml in 1 vial. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Cortaren Corticosteroid/anti-inflammatory System?

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.

Which are Cortaren Corticosteroid/anti-inflammatory System UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Cortaren Corticosteroid/anti-inflammatory System Inactive Ingredients 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 Cortaren Corticosteroid/anti-inflammatory System?

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:
  • 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: 1724880 - BUPivacaine HCl 0.5 % in 10 ML Injection
  • RxCUI: 1724880 - 10 ML bupivacaine hydrochloride 5 MG/ML Injection

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Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] 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.

[12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".