NDC Package 70529-053-01 Ludaxine
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:
70529-053-01
Package Description:
1 KIT in 1 PACKAGE * 30 mL in 1 VIAL, MULTI-DOSE * 50 mL in 1 VIAL, MULTI-DOSE
Product Code:
Proprietary Name:
Ludaxine
Usage Information:
A. Intravenous or intramuscular administration. When 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: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 cancer.2. 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.3. Collagen diseases. During an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosus.Acute rheumatic carditis.4. 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.Allergic corneal marginal ulcers.Keratitis.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 anti-tuberculosis chemotherapy.Loeffler's syndrome not manageable by other means.Aspiration pneumonitis.9. Hematologic disorders:Acquired (autoimmune) hemolytic anemia.Idiopathic thrombocytopenic purpura in adults (I.V. only; I.M. administration is contraindicated).Secondary thrombocytopenia in adults.Erythroblastopenia (RBC anemia).Congenital (erythroid) hypoplastic anemia.10. Neoplastic diseases. For palliative management of:Leukemias and lymphomas in adults.Acute leukemia of childhood.11. 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. Nervous system.Acute exacerbations of multiple sclerosis.13. Miscellaneous.Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate anti-tuberculosis chemotherapy.Trichinosis with neurologic or myocardial involvement.Diagnostic testing of adrenocortical hyperfunction.Cerebral edema of diverse etiologies in conjunction with adequate neurological evaluation and management.B. Intra-articular or soft tissue administration. When the strength and dosage form of the drug lend the preparation to the treatment of the condition, those products labeled for intra-articular or soft tissue administration are indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Synovitis of osteoarthritis.Rheumatoid arthritis.Acute and subacute bursitis.Acute gouty arthritis.Epicondylitis.Acute nonspecific tenosynovitis.Post-traumatic osteoarthritis.C. Intralesional administration. When the strength and dosage form of the drug lend the preparation to the treatment of the condition, those products labeled for intralesional administration are indicated for:Keloids.Localized hypertrophic, infiltrated, inflammatory lesions of: lichen planus, psoriatic plaques, granuloma annulare, and lichen simplex chronicus (neurodermatitis).Discoid lupus erythematosus.Necrobiosis lipoidica diabeticorum.Alopecia areata.They also may be useful in cystic tumors of an aponeurosis tendon (ganglia).
Bupivacaine hydrochloride injection USP is indicated for the production of local or regional anesthesia or analgesia for surgery, 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 bupivacaine hydrochloride injection USP in these patients.Bupivacaine hydrochloride injection USP is not recommended for intravenous regional anesthesia (Bier Block). See WARNINGS. The routes of administration and indicated bupivacaine hydrochloride injection USP 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 (see PRECAUTIONS)(See DOSAGE AND ADMINISTRATION for additional information.) Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of bupivacaine hydrochloride injection USP.
11-Digit NDC Billing Format:
70529005301
NDC to RxNorm Crosswalk:
Labeler Name:
It3 Medical Llc
Sample Package:
No
Start Marketing Date:
11-01-2018
Listing Expiration Date:
12-31-2023
Exclude Flag:
I
Code Structure:
- 70529 - It3 Medical Llc
- 70529-053 - Ludaxine
- 70529-053-01 - 1 KIT in 1 PACKAGE * 30 mL in 1 VIAL, MULTI-DOSE * 50 mL in 1 VIAL, MULTI-DOSE
- 70529-053 - Ludaxine
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 70529-053-01?
The NDC Packaged Code 70529-053-01 is assigned to a package of 1 kit in 1 package * 30 ml in 1 vial, multi-dose * 50 ml in 1 vial, multi-dose of Ludaxine, labeled by It3 Medical Llc. The product's dosage form is and is administered via form.
Is NDC 70529-053 included in the NDC Directory?
No, Ludaxine with product code 70529-053 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by It3 Medical Llc on November 01, 2018 and its listing in the NDC Directory is set to expire on December 31, 2023 if the product is not updated or renewed by the manufacturer.
What is the 11-digit format for NDC 70529-053-01?
The 11-digit format is 70529005301. 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 5-3-2 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 |
|---|---|---|---|
| 5-3-2 | 70529-053-01 | 5-4-2 | 70529-0053-01 |