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  4. NDC Product Code: 70529-005 Durapren 0.5%

NDC 70529-005 Durapren 0.5%

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 70529-005?
  4. Durapren 0.5% 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:
70529-005
Proprietary Name:
Durapren 0.5%
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
It3 Medical Llc
Labeler Code:
70529
Product Label ID:
ed820739-b9f4-454b-b8b7-a9df81f24c4e
Start Marketing Date: [9]
03-01-2017
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Packages

NDC Code 70529-005-01

Package Description: 1 VIAL, SINGLE-DOSE in 1 PACKAGE / 30 mL in 1 VIAL, SINGLE-DOSE

Product Details

What is NDC 70529-005?

The NDC code 70529-005 is assigned by the FDA to the product Durapren 0.5% which is product labeled by It3 Medical Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 70529-005-01 1 vial, single-dose in 1 package / 30 ml in 1 vial, single-dose. 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 Durapren 0.5%?

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 Durapren 0.5% UNII Codes?

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

Which are Durapren 0.5% 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 Durapren 0.5%?

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".