NDC Package 53225-4210-1 Readysharp Anesthetics Plus Dexamethasone
View Billable Units, 11-Digit Format, RxNorm
Package Information
This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
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:
53225-4210-1
Package Description:
1 KIT in 1 KIT * 1 mL in 1 VIAL (0641-0367-21) * 10 mL in 1 VIAL, SINGLE-DOSE (0409-1560-10) * 2 mL in 1 AMPULE (0409-4713-42)
Product Code:
Proprietary Name:
Readysharp Anesthetics Plus Dexamethasone
Usage Information:
Lidocaine Hydrochloride Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.
MARCAINE is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia. (See
WARNINGS.)
Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of 0.75% concentration of MARCAINE in these patients.MARCAINE is not recommended for intravenous regional anesthesia (Bier Block). See
WARNINGS.
The routes of administration and indicated MARCAINE concentrations are:∙ local infiltration 0.25%∙ peripheral nerve block 0.25% and 0.5%∙ retrobulbar block 0.75%∙ sympathetic block 0.25%∙ lumbar epidural 0.25%, 0.5%, and 0.75% (0.75% not for obstetrical anesthesia)∙ caudal 0.25% and 0.5%∙ epidural test dose 0.5% with epinephrine 1:200,000∙ dental blocks 0.5% with epinephrine 1:200,000(See
DOSAGE AND ADMINISTRATION for additional information.)
Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of MARCAINE.
A. By Intravenous or Intramuscular Injection When Oral Therapy is not Feasible:1. ENDOCRINE DISORDERSPrimary 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 doubtfulShock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspectedCongenital adrenal hyperplasiaNonsuppurative thyroiditisHypercalcemia associated with cancer2. RHEUMATIC DISORDERSAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Post-traumatic osteoarthritisSynovitis of osteoarthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Acute and subacute bursitisEpicondylitisAcute nonspecific tenosynovitisAcute gouty arthritisPsoriatic arthritisAnkylosing spondylitis3. COLLAGEN DISEASESDuring an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusAcute rheumatic carditis4. DERMATOLOGIC DISEASESPemphigusSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisBullous dermatitis herpetiformisSevere seborrheic dermatitisSevere psoriasisMycosis fungoides5. ALLERGIC STATESControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in:Bronchial asthmaContact dermatitisAtopic dermatitisSerum sicknessSeasonal or perennial allergic rhinitisDrug hypersensitivity reactionsUrticarial transfusion reactionsAcute noninfectious laryngeal edema (epinephrine is the drug of first choice)6. OPHTHALMIC DISEASESSevere acute and chronic allergic and inflammatory processes involving the eye, such as:Herpes zoster ophthalmicusIritis, iridocyclitisChorioretinitisDiffuse posterior uveitis and choroiditisOptic neuritisSympathetic ophthalmiaAnterior segment inflammationAllergic conjunctivitisKeratitisAllergic corneal marginal ulcers7. GASTROINTESTINAL DISEASESTo tide the patient over a critical period of the disease in:Ulcerative colitis (Systemic therapy)Regional enteritis (Systemic therapy)8. RESPIRATORY DISEASESSymptomatic sarcoidosisBerylliosisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyLoeffler's syndrome not manageable by other meansAspiration pneumonitis9. HEMATOLOGIC DISORDERSAcquired (autoimmune) hemolytic anemiaIdiopathic thrombocytopenic purpura in adults (IV only; IM administration is contraindicated)Secondary thrombocytopenia in adultsErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia10. NEOPLASTIC DISEASESFor palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood11. EDEMATOUS STATESTo induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type, or that due to lupus erythematosus12. MISCELLANEOUSTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis with neurologic or myocardial involvement13. DIAGNOSTIC TESTING OF ADRENOCORTICAL HYPERFUNCTION14. 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 InjectionAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Synovitis of osteoarthritisRheumatoid arthritisAcute and subacute bursitisAcute gouty arthritisEpicondylitisAcute nonspecific tenosynovitisPost-traumatic osteoarthritisC. By Intralesional InjectionKeloidsLocalized hypertrophic, infiltrated, inflammatory lesions of: lichen planus, psoriatic plaques, granuloma annulare, and lichen simplex chronicus (neurodermatitis)Discoid lupus erythematosusNecrobiosis lipoidica diabeticorumAlopecia areataMay also be useful in cystic tumors of an aponeurosis or tendon (ganglia).
11-Digit NDC Billing Format:
53225421001
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
Labeler Name:
Terrain Pharmaceuticals
Sample Package:
No
Start Marketing Date:
12-29-2015
Listing Expiration Date:
12-31-2018
Exclude Flag:
I
Code Structure:
- 53225 - Terrain Pharmaceuticals
- 53225-4210 - Readysharp Anesthetics Plus Dexamethasone
- 53225-4210-1 - 1 KIT in 1 KIT * 1 mL in 1 VIAL (0641-0367-21) * 10 mL in 1 VIAL, SINGLE-DOSE (0409-1560-10) * 2 mL in 1 AMPULE (0409-4713-42)
- 53225-4210 - Readysharp Anesthetics Plus Dexamethasone
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.
Frequently Asked Questions
What is NDC 53225-4210-1?
The NDC Packaged Code 53225-4210-1 is assigned to a package of 1 kit in 1 kit * 1 ml in 1 vial (0641-0367-21) * 10 ml in 1 vial, single-dose (0409-1560-10) * 2 ml in 1 ampule (0409-4713-42) of Readysharp Anesthetics Plus Dexamethasone, labeled by Terrain Pharmaceuticals. The product's dosage form is and is administered via form.
Is NDC 53225-4210 included in the NDC Directory?
No, Readysharp Anesthetics Plus Dexamethasone with product code 53225-4210 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Terrain Pharmaceuticals on December 29, 2015 and its listing in the NDC Directory is set to expire on December 31, 2018 if the product is not updated or renewed by the manufacturer.
What is the NDC billing unit for package 53225-4210-1?
The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.
What is the 11-digit format for NDC 53225-4210-1?
The 11-digit format is 53225421001. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.
This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:
| 10-Digit Format | 10-Digit Original Code | 11-Digit Format | 11-Digit Code |
|---|---|---|---|
| 5-4-1 | 53225-4210-1 | 5-4-2 | 53225-4210-01 |