NDC Package 0517-0791-01 Betamethasone Sodium Phosphate And Betamethasone Acetate

Injection, Suspension Intra-articular; Intralesional; Intramuscular - View Billable Units, 11-Digit Format, RxNorm

Package Information

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:
0517-0791-01
Package Description:
1 VIAL, MULTI-DOSE in 1 CARTON / 5 mL in 1 VIAL, MULTI-DOSE
Product Code:
Proprietary Name:
Betamethasone Sodium Phosphate And Betamethasone Acetate
Non-Proprietary Name:
Betamethasone Sodium Phosphate And Betamethasone Acetate
Substance Name:
Betamethasone Acetate; Betamethasone Sodium Phosphate
Usage Information:
When oral therapy is not feasible, the intramuscular use of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as follows:Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions.Dermatologic Diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome).Endocrine Disorders Congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis.Hydrocortisone or cortisone is the drug of choice in primary or secondary adrenocortical insufficiency.  Synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance.Gastrointestinal Diseases To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis.Hematologic Disorders Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia.Miscellaneous Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy.Neoplastic Diseases For palliative management of leukemias and lymphomas.Nervous System Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy.Ophthalmic Diseases Sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids.Renal Diseases To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus.Respiratory Diseases Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy).  For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.The intra-articular or soft tissue administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.The intralesional administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated for alopecia areata; discoid lupus erythematosus; keloids; localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus (neurodermatitis), and psoriatic plaques; necrobiosis lipoidica diabeticorum.Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension may also be useful in cystic tumors of an aponeurosis or tendon (ganglia).
11-Digit NDC Billing Format:
00517079101
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 578803 - betamethasone sodium phosphate / betamethasone acetate 6 MG/ML Injectable Suspension
  • RxCUI: 578803 - betamethasone 3 MG/ML / betamethasone acetate 3 MG/ML Injectable Suspension
  • RxCUI: 578803 - betamethasone 3 MG/ML (as betamethasone sodium phosphate) / betamethasone acetate 3 MG/ML Injectable Suspension
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    American Regent, Inc.
    Dosage Form:
    Injection, Suspension - A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. It can also consist of an oil phase dispersed throughout an aqueous phase, or vice-versa.
    Administration Route(s):
  • Intra-articular - Administration within a joint.
  • Intralesional - Administration within or introduced directly into a localized lesion.
  • Intramuscular - Administration within a muscle.
  • Sample Package:
    No
    FDA Application Number:
    ANDA090747
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-01-2019
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 0517-0791-01 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    00517079101J0702Betamethasone acet&sod phosp3 MG & 3 MG5155

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0517-0791-01?

    The NDC Packaged Code 0517-0791-01 is assigned to a package of 1 vial, multi-dose in 1 carton / 5 ml in 1 vial, multi-dose of Betamethasone Sodium Phosphate And Betamethasone Acetate, a human prescription drug labeled by American Regent, Inc.. The product's dosage form is injection, suspension and is administered via intra-articular; intralesional; intramuscular form.

    Is NDC 0517-0791 included in the NDC Directory?

    Yes, Betamethasone Sodium Phosphate And Betamethasone Acetate with product code 0517-0791 is active and included in the NDC Directory. The product was first marketed by American Regent, Inc. on November 01, 2019 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0517-0791-01?

    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 0517-0791-01?

    The 11-digit format is 00517079101. 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 4-4-2 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 Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20517-0791-015-4-200517-0791-01