Methylprednisolone
NDC Package 50436-0001-1

11-digit billing NDC: 50436000101 · Billing unit: EA · 21 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Methylprednisolone is tablets are indicated in the following conditions:1.Endocrine DisordersPrimary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance).Congenital 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:Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisSynovitis of osteoarthritisAcute nonspecific tenosynovitisPost-traumatic osteoarthritisPsoriatic arthritisEpicondylitisAcute gouty arthritis3.Collagen DiseasesDuring an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis)Acute rheumatic carditis4.Dermatologic DiseasesBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome) Severe seborrheic dermatitisExfoliative dermatitisMycosis fungoidesPemphigusSevere psoriasis5.Allergic StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisDrug hypersensitivity reactionsSerum sicknessContact dermatitisBronchial asthmaAtopic dermatitis6.Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic corneal marginal ulcersHerpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmia KeratitisOptic neuritisAllergic conjunctivitis Chorioretinitis Iritis and iridocyclitis7.Respiratory Diseases Symptomatic sarcoidosis BerylliosisLoeffler’s syndrome not manageable by other meansFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitis8.Hematologic DisordersIdiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia9.Neoplastic DiseasesFor palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood10.Edematous StatesTo induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.11.Gastrointestinal DiseasesTo tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis12.Nervous System Acute exacerbations of multiple sclerosis13.MiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.Trichinosis with neurologic or myocardial involvement. Marketed by Unit Dose Services, this product is identified by NDC 50436-0001 and is authorized under FDA application ANDA040189.

Identification & Billing

NDC Package Code
50436-0001-1
Package Description
21 TABLET in 1 BOTTLE
Product Code
50436-0001
11-Digit Billing Format
50436000101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
21 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Methylprednisolone
Dosage Form
-
Usage Information
Methylprednisolone Tablets are indicated in the following conditions:1.Endocrine DisordersPrimary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance).Congenital 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:Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisSynovitis of osteoarthritisAcute nonspecific tenosynovitisPost-traumatic osteoarthritisPsoriatic arthritisEpicondylitisAcute gouty arthritis3.Collagen DiseasesDuring an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis)Acute rheumatic carditis4.Dermatologic DiseasesBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome) Severe seborrheic dermatitisExfoliative dermatitisMycosis fungoidesPemphigusSevere psoriasis5.Allergic StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisDrug hypersensitivity reactionsSerum sicknessContact dermatitisBronchial asthmaAtopic dermatitis6.Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic corneal marginal ulcersHerpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmia KeratitisOptic neuritisAllergic conjunctivitis Chorioretinitis Iritis and iridocyclitis7.Respiratory Diseases Symptomatic sarcoidosis BerylliosisLoeffler’s syndrome not manageable by other meansFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitis8.Hematologic DisordersIdiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia9.Neoplastic DiseasesFor palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood10.Edematous StatesTo induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.11.Gastrointestinal DiseasesTo tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis12.Nervous System Acute exacerbations of multiple sclerosis13.MiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.Trichinosis with neurologic or myocardial involvement.

Regulatory & Marketing

Labeler Name
Unit Dose Services
FDA Application #
ANDA040189
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-31-1997
Listing Expiration
12-31-2022
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

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 50436-0001-1 identifies a specific commercial package of 21 tablet in 1 bottle of Methylprednisolone, labeled by Unit Dose Services. This product is billed for "EA" each discreet unit and contains an estimated amount of 21 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Unit Dose Services on October 31, 1997. The current certification is valid through December 31, 2022.

How is this Unit Dose Services product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50436000101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 21 total billable units per package. 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 (5-4-1)
50436-0001-1
11-Digit CMS (5-4-2)
50436-0001-01

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