NDC 63323-411-25 Midazolam

Midazolam Hydrochloride

NDC Package Code 63323-411-25

Field Name Field Value
NDC Code 63323-411-25
Package Description 25 VIAL in 1 TRAY > 5 mL in 1 VIAL (63323-411-18)
Proprietary Name Midazolam Additional informationCallout TooltipWhat 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 Midazolam Hydrochloride Additional informationCallout TooltipWhat 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.
11-Digit NDC Billing Format 63323041125 Additional informationCallout TooltipNDC 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 Additional informationCallout TooltipWhat 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 Fresenius Kabi Usa, 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.
Administration Route(s)
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
  • MIDAZOLAM HYDROCHLORIDE 1 mg/mL
Pharmacological Class(es)
  • Benzodiazepine - [EPC] (Established Pharmacologic Class)
  • Benzodiazepines - [CS]
DEA Schedule Schedule IV (CIV) Substances Additional informationCallout TooltipWhat is the Drug Enforcement Administration (DEA) CIV Schedule?
The controlled substances in the CIV schedule have an abuse potential and dependence liability less than those listed in CIII and have an accepted medical use in the United States.
Sample Package No Additional informationCallout TooltipSample 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. Additional informationCallout TooltipWhat 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 ANDA075154 Additional informationCallout TooltipWhat 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 07-14-2000 Additional informationCallout TooltipWhat 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 12-31-2019 Additional informationCallout TooltipWhat is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

The NDC Code 63323-411-25 is assigned to Midazolam, a human prescription drug labeled by Fresenius Kabi Usa, Llc. The product's dosage form is injection, solution and is administered via intramuscular; intravenous form.


Code Structure
  • 63323 - Fresenius Kabi Usa, Llc
    • 63323-411 - Midazolam
      • 63323-411-25 - 25 VIAL in 1 TRAY

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 disclaimer below.

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 63323-411-25 HCPCS crosswalk information with package details and bill units information.

NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
63323041125J2250Inj midazolam hydrochloride1 MG5255125

* Please review the disclaimer below.

Other Product Packages

The following packages are also available for Midazolam with product NDC 63323-411.

NDC Package CodePackage Description
63323-411-1010 VIAL in 1 TRAY > 10 mL in 1 VIAL (63323-411-13)
63323-411-1225 VIAL in 1 TRAY > 2 mL in 1 VIAL (63323-411-15)

* Please review the disclaimer below.

Previous Code
63323-407
Next Code
63323-412