NDC 0362-9013 Prilocaine Hydrochloride With Epinephrine

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
0362-9013
Proprietary Name:
Prilocaine Hydrochloride With Epinephrine
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Labeler Code:
0362
Start Marketing Date: [9]
09-10-2011
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
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Product Details

What is NDC 0362-9013?

The NDC code 0362-9013 is assigned by the FDA to the product Prilocaine Hydrochloride With Epinephrine which is product labeled by Septodont Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 0362-9013-50 50 cartridge in 1 carton / 1.8 ml in 1 cartridge. 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 Prilocaine Hydrochloride With Epinephrine?

Prilocaine Hydrochloride 4% with Epinephrine 1:200,000 injection is indicated for the production of local anesthesia in dentistry by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended.

Which are Prilocaine Hydrochloride With Epinephrine UNII Codes?

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

Which are Prilocaine Hydrochloride With Epinephrine 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 Prilocaine Hydrochloride With Epinephrine?

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:
  • RxCUI: 1596950 - prilocaine HCl 4 % / EPINEPHrine 1:200,000 in 1.8 ML Cartridge
  • RxCUI: 1596950 - 1.8 ML epinephrine 0.005 MG/ML / prilocaine hydrochloride 40 MG/ML Cartridge
  • RxCUI: 1596950 - epinephrine 1:200,000 / prilocaine HCl 4 % 1.8 ML Cartridge
  • RxCUI: 1596950 - prilocaine HCl 4 % / epinephrine (as epinephrine bitartrate) 1:200,000 in 1.8 ML Cartridge

* Please review the disclaimer below.

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".