Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.
NDC Package Code:
76420-219-01
Package Description:
1 KIT in 1 CARTON * 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-197-20) / 20 mL in 1 VIAL, SINGLE-DOSE * .9 mL in 1 PACKET (67777-419-02) * 25 VIAL in 1 TRAY (63323-506-01) / 1 mL in 1 VIAL
Non-Proprietary Name:
Dexamethasone Sodium Phosphate, Ropivacaine Hydrochloride, Povidine Iodine
Usage Information:
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 cancer2. 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 spondylitis3. Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Acute rheumatic carditis4. 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 anemia10. Neoplastic Diseases For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood11. 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 Tuberculous 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.
Ropivacaine hydrochloride injection, USP is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration
11-Digit NDC Billing Format:
76420021901
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Product Type:
Human Prescription Drug
Labeler Name:
Asclemed Usa, Inc.
Dosage Form:
Kit - A packaged collection of related material.
Administration Route(s):
Epidural - Administration upon or over the dura mater.
Infiltration - Administration that results in substances passing into tissue spaces or into cells.
Intramuscular - Administration within a muscle.
Intravenous - Administration within or into a vein or veins.
Perineural - Administration surrounding a nerve or nerves.
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Marketing Category:
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date:
06-10-2019
Listing Expiration Date:
12-31-2024
Code Structure:
- 76420 - Asclemed Usa, Inc.
- 76420-219 - Ropidex
-
76420-219-01 - 1 KIT in 1 CARTON * 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-197-20) / 20 mL in 1 VIAL, SINGLE-DOSE * .9 mL in 1 PACKET (67777-419-02) * 25 VIAL in 1 TRAY (63323-506-01) / 1 mL in 1 VIAL
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 disclaimer below.