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  4. NDC Product Code: 0143-9754 Methylprednisolone Sodium Succinate

NDC 0143-9754 Methylprednisolone Sodium Succinate

Injection, Powder, For Solution Intramuscular; Intravenous - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 0143-9754?
  4. Methylprednisolone Sodium Succinate Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes

Product Information

NDC Product Code:
0143-9754
Proprietary Name:
Methylprednisolone Sodium Succinate
Non-Proprietary Name: [1]
Methylprednisolone Sodium Succinate
Substance Name: [2]
Methylprednisolone Sodium Succinate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection, Powder, For Solution - A sterile preparation intended for reconstitution to form a solution for parenteral use.
Administration Route(s): [4]
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
    • Labeler Name: [5]
    Hikma Pharmaceuticals Usa Inc.
    Labeler Code:
    0143
    Product Label ID:
    05d95a56-b03a-4d5b-9877-2853ac470fa1
    FDA Application Number: [6]
    ANDA203125
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    09-26-2022
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
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    Product Details

    What is NDC 0143-9754?

    The NDC code 0143-9754 is assigned by the FDA to the product Methylprednisolone Sodium Succinate which is a human prescription drug product labeled by Hikma Pharmaceuticals Usa Inc.. The product's dosage form is injection, powder, for solution and is administered via intramuscular; intravenous form. The product is distributed in a single package with assigned NDC code 0143-9754-25 25 vial, single-dose in 1 carton / 1 injection, powder, for solution in 1 vial, single-dose (0143-9754-01). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Methylprednisolone Sodium Succinate?

    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, the intravenous or intramuscular use of Methylprednisolone Sodium Succinate for Injection is indicated as follows:Allergic statesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions.Dermatologic diseasesBullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome).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), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseasesTo tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis.Hematologic disordersAcquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia.MiscellaneousTrichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.Neoplastic diseasesFor the palliative management of leukemias and lymphomas.Nervous SystemAcute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy.Ophthalmic diseasesSympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids.Renal diseasesTo induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus.Respiratory diseasesBerylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.Rheumatic disordersAs 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, temporal arteritis, polymyositis, and systemic lupus erythematosus.

    What are Methylprednisolone Sodium Succinate Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    Which are Methylprednisolone Sodium Succinate UNII Codes?

    The UNII codes for the active ingredients in this product are:

    • METHYLPREDNISOLONE SODIUM SUCCINATE (UNII: LEC9GKY20K)
    • METHYLPREDNISOLONE (UNII: X4W7ZR7023) (Active Moiety)

    Which are Methylprednisolone Sodium Succinate Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Methylprednisolone Sodium Succinate?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

    Which are the Pharmacologic Classes for Methylprednisolone Sodium Succinate?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".