Sensorcaine Injection, Solution
NDC Package 63323-460-37

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Sensorcaine (bupivacaine hydrochloride and epinephrine bitartrate) injection is sensorcaine (bupivacaine HCl) 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). This formulation utilizes a injection, solution delivery system. Marketed by Fresenius Kabi Usa, Llc, this product is identified by NDC 63323-460 and is authorized under FDA application NDA018304.

Identification & Billing

NDC Package Code
63323-460-37
Package Description
25 VIAL, SINGLE-DOSE in 1 TRAY / 30 mL in 1 VIAL, SINGLE-DOSE (63323-460-01)
Product Code
63323-460
11-Digit Billing Format
63323046037
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1012391 - BUPivacaine HCl 0.75 % / EPINEPHrine 1:200,000 in 30 ML Injection
  • RxCUI: 1012391 - 30 ML bupivacaine hydrochloride 7.5 MG/ML / epinephrine 0.005 MG/ML Injection
  • RxCUI: 1012391 - bupivacaine HCl 0.75 % / epinephrine (as epinephrine bitartrate) 1:200,000 per 30 ML Injection
  • RxCUI: 1012396 - BUPivacaine HCl 0.25 % Injectable Solution
  • RxCUI: 1012396 - bupivacaine hydrochloride 2.5 MG/ML Injectable Solution

Clinical Specifications

Proprietary Name
Sensorcaine Mpf
Non-Proprietary Name
Bupivacaine Hydrochloride And Epinephrine Bitartrate
Substance Name
Bupivacaine Hydrochloride; Epinephrine Bitartrate
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
  • Epidural - Administration upon or over the dura mater.
  • Retrobulbar - Administration behind the pons or behind the eyeball.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Sensorcaine (bupivacaine HCl) 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 the 0.75% concentration of bupivacaine HCl in these patients. Sensorcaine is not recommended for intravenous regional anesthesia (Bier Block) (see WARNINGS).The routes of administration and indicated Sensorcaine 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 Sensorcaine. 

Regulatory & Marketing

Labeler Name
Fresenius Kabi Usa, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA018304
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-19-2010
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 63323-460-37 identifies a specific commercial package of 25 vial, single-dose in 1 tray / 30 ml in 1 vial, single-dose (63323-460-01) of Sensorcaine Mpf, a human prescription drug labeled by Fresenius Kabi Usa, Llc. This injection, solution is formulated for epidural; retrobulbar use and contains bupivacaine hydrochloride; epinephrine bitartrate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Fresenius Kabi Usa, Llc on November 19, 2010. The current certification is valid through December 31, 2026.

How is this Fresenius Kabi Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63323046037. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
63323-460-37
11-Digit CMS (5-4-2)
63323-0460-37

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.