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  4. NDC Product Code: 55648-765 Midazolam Hydrochloride

NDC 55648-765 Midazolam Hydrochloride

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 55648-765?
  4. Midazolam Hydrochloride Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
55648-765
Proprietary Name:
Midazolam Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Wockhardt Limited
Labeler Code:
55648
Product Label ID:
c94e8384-28b1-4668-95fe-3202497490ae
Start Marketing Date: [9]
11-10-2008
Listing Expiration Date: [11]
12-31-2019
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Packages

NDC Code 55648-765-01

Package Description: 10 VIAL in 1 CARTON / 1 mL in 1 VIAL (55648-765-05)

NDC Code 55648-765-02

Package Description: 10 VIAL in 1 CARTON / 2 mL in 1 VIAL (55648-765-06)

NDC Code 55648-765-03

Package Description: 25 VIAL in 1 CARTON / 1 mL in 1 VIAL (55648-765-05)

NDC Code 55648-765-04

Package Description: 25 VIAL in 1 CARTON / 2 mL in 1 VIAL (55648-765-06)

Product Details

What is NDC 55648-765?

The NDC code 55648-765 is assigned by the FDA to the product Midazolam Hydrochloride which is product labeled by Wockhardt Limited. The product's dosage form is . The product is distributed in 4 packages with assigned NDC codes 55648-765-01 10 vial in 1 carton / 1 ml in 1 vial (55648-765-05), 55648-765-02 10 vial in 1 carton / 2 ml in 1 vial (55648-765-06), 55648-765-03 25 vial in 1 carton / 1 ml in 1 vial (55648-765-05), 55648-765-04 25 vial in 1 carton / 2 ml in 1 vial (55648-765-06). 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 Midazolam Hydrochloride?

Midazolam hydrochloride injection, USP is indicated:intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia;intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other CNS depressants;intravenously for induction of general anesthesia, before administration of other anesthetic agents. With the use of narcotic premedication, induction of anesthesia can be attained within a relatively narrow dose range and in a short period of time. Intravenous midazolam can also be used as a component of intravenous supplementation of nitrous oxide and oxygen (balanced anesthesia);continuous intravenous infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in a critical care setting.Midazolam is associated with a high incidence of partial or complete impairment of recall for the next several hours (see CLINICAL PHARMACOLOGY).

Which are Midazolam Hydrochloride UNII Codes?

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

Which are Midazolam Hydrochloride 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 Midazolam Hydrochloride?

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:

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Product Footnotes

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

[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".