NDC 63323-293-37 Polocaine-mpf
Mepivacaine Hydrochloride Injection, Solution Epidural; Infiltration

Package Information
NDC HCPCS Crosswalk
Frequently Asked Questions

Package Information

The table below has all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code	63323-293-37
Package Description	25 VIAL, SINGLE-DOSE in 1 TRAY / 30 mL in 1 VIAL, SINGLE-DOSE (63323-293-01)
Product Code	63323-293
Proprietary Name What 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.	Polocaine-mpf
Non-Proprietary Name What 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.	Mepivacaine Hydrochloride
Substance Name What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.	Mepivacaine Hydrochloride
Usage Information Product Usage Information The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.	POLOCAINE (Mepivacaine HCl Injection, USP), is indicated for production of local or regional analgesia and anesthesia by local infiltration, peripheral nerve block techniques, and central neural techniques including epidural and caudal blocks.The routes of administration and indicated concentrations for mepivacaine are: local infiltration 0.5% (via diluation) or 1 %peripheral nerve blocks 1% and 2% epidural block 1%, 1.5%, 2% caudal block 1%, 1.5%, 2% See DOSAGE AND ADMINISTRATION for additional information. Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of mepivacaine.
11-Digit NDC Billing Format NDC 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.	63323029337
Billing Unit	ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk	RxCUI: 1012722 - mepivacaine HCl 1 % Injectable Solution RxCUI: 1012722 - mepivacaine hydrochloride 10 MG/ML Injectable Solution RxCUI: 1012722 - mepivacaine hydrochloride 1 % Injectable Solution RxCUI: 1012726 - Polocaine 1 % Injectable Solution RxCUI: 1012726 - mepivacaine hydrochloride 10 MG/ML Injectable Solution [Polocaine]
Product Type What 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.	Human Prescription Drug
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)	Epidural - Administration upon or over the dura mater. Infiltration - Administration that results in substances passing into tissue spaces or into cells.
Active Ingredient(s)	MEPIVACAINE HYDROCHLORIDE 15 mg/mL
Pharmacologic Class(es)	Amide Local Anesthetic - [EPC] (Established Pharmacologic Class) Amides - [CS] Local Anesthesia - [PE] (Physiologic Effect)
Sample Package Sample Package? This field Indicates whether this package is a sample packaging or not.	No
Marketing Category 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.	ANDA - A product marketed under an approved Abbreviated New Drug Application.
FDA Application Number 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.	ANDA089408
Start Marketing Date What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.	07-21-2009
Listing Expiration Date 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.	12-31-2023
Exclude Flag 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".	N
NDC Code Structure	63323 - Fresenius Kabi Usa, Llc 63323-293 - Polocaine-mpf 63323-293-37 - 25 VIAL, SINGLE-DOSE in 1 TRAY / 30 mL in 1 VIAL, SINGLE-DOSE (63323-293-01)

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.

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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 63323-293-37 HCPCS crosswalk information with package details and bill units information.

NDC Billing Code	HCPCS Code	HCPCS Code Desc.	Dosage	Package Size	Package Quantity	Billable Units	Billable Units / Pkg
63323029337	J0670	Inj mepivacaine hcl/10 ml	10 ML	30	25	3	75

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 63323-293-37?

The NDC Packaged Code 63323-293-37 is assigned to a package of 25 vial, single-dose in 1 tray / 30 ml in 1 vial, single-dose (63323-293-01) of Polocaine-mpf, a human prescription drug labeled by Fresenius Kabi Usa, Llc. The product's dosage form is injection, solution and is administered via epidural; infiltration form.

Is NDC 63323-293 included in the NDC Directory?

Yes, Polocaine-mpf with product code 63323-293 is active and included in the NDC Directory. The product was first marketed by Fresenius Kabi Usa, Llc on July 21, 2009 and its listing in the NDC Directory is set to expire on December 31, 2023 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 63323-293-37?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

What is the 11-digit format for NDC 63323-293-37?

The 11-digit format is 63323029337. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Package Format	10-Digit Original Package Code	11-Digit Package Format	11-Digit Conversion Package Code
5-3-2	63323-293-37	5-4-2	63323-0293-37

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