NDC Package Code 67457-418-05
The NDC Code 67457-418-05 is assigned to a package of 25 vial in 1 carton > 5 ml in 1 vial (67457-418-00) of Dexamethasone Sodium Phosphate, a human prescription drug labeled by Mylan Institutional Llc. The product's dosage form is injection, solution and is administered via intra-articular; intralesional; intramuscular; intravenous; soft tissue form.
|Field Name||Field Value|
|Package Description||25 VIAL in 1 CARTON > 5 mL in 1 VIAL (67457-418-00)|
|Proprietary Name||Dexamethasone Sodium Phosphate 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.
|Non-Proprietary Name||Dexamethasone Sodium Phosphate 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.
|Drug Uses||This medication is used to treat various conditions such as severe allergic reactions, arthritis, blood diseases, breathing problems, certain cancers, eye diseases, intestinal disorders, and skin diseases. It is also used to test for an adrenal gland disorder (Cushing's syndrome). It decreases your body's natural defensive response and reduces symptoms such as swelling and allergic-type reactions. Dexamethasone is a corticosteroid hormone (glucocorticoid). This injectable form of dexamethasone is used when a similar drug cannot be taken by mouth or when a very fast response is needed, especially in patients with severe medical conditions. Talk to your doctor about the risks and benefits of dexamethasone, especially if it is to be injected near your spine (epidural). Rare but serious side effects may occur with epidural use. This drug may also be used with other medications as a replacement for certain hormones.|
|11-Digit NDC Billing Format||67457041805 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.
|Billing Unit||ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.|
|Product Type||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.
|Labeler Name||Mylan Institutional Llc|
|Dosage Form||Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.|
|Sample Package||No Sample Package?
This field Indicates whether this package is a sample packaging or not.
|Marketing Category||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||ANDA040803 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||04-15-2020 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||12-31-2021 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.
|Exclude Flag||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. Values = ‘Y’ or ‘N’.
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 67457-418-05 HCPCS crosswalk information with package details and bill units information.
|NDC Billing Code||HCPCS Code||HCPCS Code Desc.||Dosage||Package Size||Package Quantity||Billable Units||Billable Units / Pkg|
|67457041805||J1100||Dexamethasone sodium phos||1 MG||5||25||20||500|
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