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  4. NDC Product Code: 53225-3125 Readysharp-a

NDC 53225-3125 Readysharp-a

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 53225-3125?
  4. Readysharp-a 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:
53225-3125
Proprietary Name:
Readysharp-a
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Terrain Pharmaceuticals
Labeler Code:
53225
Product Label ID:
28115cb6-118b-612a-e054-00144ff88e88
FDA Application Number: [6]
NDA016964
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
12-29-2015
Listing Expiration Date: [11]
12-31-2018
Exclude Flag: [12]
I
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Product Details

What is NDC 53225-3125?

The NDC code 53225-3125 is assigned by the FDA to the product Readysharp-a which is product labeled by Terrain Pharmaceuticals. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 53225-3125-1 1 kit in 1 kit * 2 ml in 1 ampule (0409-4713-42) * 10 ml in 1 vial, single-dose (0409-1560-10), 53225-3125-4 1 kit in 1 carton * 2 ml in 1 ampule (0409-4713-42) * 10 ml in 1 vial, single-dose (0409-1560-10). 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 Readysharp-a?

Lidocaine Hydrochloride Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed. MARCAINE is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia. (See WARNINGS.) Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of 0.75% concentration of MARCAINE in these patients.MARCAINE is not recommended for intravenous regional anesthesia (Bier Block). See WARNINGS. The routes of administration and indicated MARCAINE concentrations are:∙ local infiltration                                                                                 0.25%∙ peripheral nerve block                                                                      0.25% and 0.5%∙ retrobulbar block                                                                              0.75%∙ sympathetic block                                                                             0.25%∙ lumbar epidural                                                                                 0.25%, 0.5%, and 0.75%                                                                                                          (0.75% not for obstetrical anesthesia)∙ caudal                                                                                               0.25% and 0.5%∙ epidural test dose                                                                              0.5% with epinephrine 1:200,000∙ dental blocks                                                                                     0.5% with epinephrine 1:200,000(See DOSAGE AND ADMINISTRATION for additional information.) Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of MARCAINE.

Which are Readysharp-a UNII Codes?

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

Which are Readysharp-a 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 Readysharp-a?

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.

[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".