Betalido Kit
NDC Package 76420-765-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Betalido Kit (betamethasone sodium phosphate, betamethasone acetate, lidocaine, povidine iodine) kits is 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. This formulation utilizes a kit delivery system. Marketed by Asclemed Usa, Inc., this product is identified by NDC 76420-765.

Identification & Billing

NDC Package Code
76420-765-01
Package Description
1 KIT in 1 CARTON * 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-162-05) / 5 mL in 1 VIAL, SINGLE-DOSE * .9 mL in 1 PACKET (67777-419-02) * 5 mL in 1 POUCH * 1 VIAL, MULTI-DOSE in 1 CARTON (0517-0720-01) / 5 mL in 1 VIAL, MULTI-DOSE
Product Code
76420-765
11-Digit Billing Format
76420076501
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Betalido Kit
Non-Proprietary Name
Betamethasone Sodium Phosphate, Betamethasone Acetate, Lidocaine, Povidine Iodine
Dosage Form
Kit - A packaged collection of related material.
Administration Route
  • Infiltration - Administration that results in substances passing into tissue spaces or into cells.
  • Intra-articular - Administration within a joint.
  • Intralesional - Administration within or introduced directly into a localized lesion.
  • Intramuscular - Administration within a muscle.
  • 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.
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). Lidocaine hydrochloride injection 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.

Regulatory & Marketing

Labeler Name
Asclemed Usa, Inc.
Product Type
Human Prescription Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
06-13-2014
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage
  • 76420 - Asclemed Usa, Inc.
    • 76420-765 - Betalido Kit
      • 76420-765-01 - 1 KIT in 1 CARTON * 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-162-05) / 5 mL in 1 VIAL, SINGLE-DOSE * .9 mL in 1 PACKET (67777-419-02) * 5 mL in 1 POUCH * 1 VIAL, MULTI-DOSE in 1 CARTON (0517-0720-01) / 5 mL in 1 VIAL, MULTI-DOSE

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 76420-765-01 identifies a specific commercial package of 1 kit in 1 carton * 10 vial, single-dose in 1 carton (55150-162-05) / 5 ml in 1 vial, single-dose * .9 ml in 1 packet (67777-419-02) * 5 ml in 1 pouch * 1 vial, multi-dose in 1 carton (0517-0720-01) / 5 ml in 1 vial, multi-dose of Betalido Kit, a human prescription drug labeled by Asclemed Usa, Inc.. This kit is formulated for infiltration; intra-articular; intralesional; intramuscular; perineural; topical use and contains as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Asclemed Usa, Inc. on June 13, 2014. The current certification is valid through December 31, 2027.

How is this Asclemed Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76420076501. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
76420-765-01
11-Digit CMS (5-4-2)
76420-0765-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.