||1 VIAL, MULTI-DOSE in 1 CARTON > 5 mL in 1 VIAL, MULTI-DOSE
||Methylprednisolone Acetate What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
||Methylprednisolone Acetate 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.
||Methylprednisolone is used to treat pain and swelling that occurs with arthritis and other joint disorders. This medication may also be used to treat various conditions such as blood disorders, severe allergic reactions, certain cancers, eye conditions, skin/intestinal/kidney/lung diseases, and immune system disorders. It decreases your immune system's response to these conditions and reduces symptoms such as swelling, pain, and allergic-type reactions. Talk to your doctor about the risks and benefits of methylprednisolone, especially if it is to be injected near your spine (epidural). Rare but serious side effects may occur with epidural use. Methylprednisolone is a corticosteroid hormone. Methylprednisolone may also be used with other medications in hormone disorders.
|11-Digit NDC Billing Format
||16714047301 NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
||ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
|RxNorm Crosswalk||1358610 and 1358617 - RxCUIs What is RxNorm?|
The RxNorm crosswalk provides a normalized naming system for generic and branded drugs by assigning unique concept identifiers (RxCUI) to each NDC.
||Human Prescription Drug 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.
||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.
- Intralesional - Administration within or introduced directly into a localized lesion.
- Intramuscular - Administration within a muscle.
- Intrasynovial - Administration within the synovial cavity of a joint.
- Soft Tissue - Administration into any soft tissue.
- METHYLPREDNISOLONE ACETATE 80 mg/mL
- Corticosteroid - [EPC] (Established Pharmacologic Class)
- Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)
||No Sample Package?
This field Indicates whether this package is a sample packaging or not.
||ANDA - A product marketed under an approved Abbreviated New Drug Application. 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.
|FDA Application Number
||ANDA040620 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.
|Start Marketing Date
||05-25-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
|Listing Expiration Date
||12-31-2022 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.
||N 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".