What is NDC 63323-461?

63323-461 is the product NDC for Sensorcaine, Bupivacaine hydrochloride 2.5 mg/mL; Epinephrine bitartrate .005 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Sensorcaine (BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE).

What is the active ingredient?

Bupivacaine hydrochloride, Epinephrine bitartrate.

Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Sensorcaine?

6 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Sensorcaine NDC 63323-461 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-461Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0461Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
63323-461-57	6332304615763323046157	25 VIAL, MULTI-DOSE in 1 TRAY (63323-461-57) / 50 mL in 1 VIAL, MULTI-DOSE (63323-461-01)Marketed from Nov 19, 2010

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Sensorcaine
Generic name (nonproprietary): bupivacaine hydrochloride and epinephrine bitartrate
Active ingredients: Bupivacaine hydrochloride — 2.5 mg/mLEpinephrine bitartrate — .005 mg/mL
Dosage form: Injection, Solution
Route: Infiltration, Perineural
Labeler: Fresenius Kabi USA, LLCNDC labeler code 63323
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 070967
Marketing start: Nov 19, 2010
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic alpha-Agonists (Mechanism)Adrenergic beta-Agonists (Mechanism)Amides (Chemical structure)Catecholamines (Chemical structure)Local Anesthesia (Physiologic effect)
Identifiers: Product ID 63323-461_cc1f6507-eb3e-4398-a1d3-0c56a2099e6bSPL ID cc1f6507-eb3e-4398-a1d3-0c56a2099e6bSPL set ID bc61a9a6-0a4e-48a9-b908-e5e66b9f23ebRxCUI 1012377, 1012384, 1012413, 1012417, 1724786, 1724787, 1724809, 1724810, 1867594, 1867596, 1867618, 1867620UNII 30Q7KI53AK, 7TQO7W3VT8UPC 0363323472030, 0363323461010, 0363323463014, 0363323468026, 0363323472016, 0363323468019
Pharmacologic class: Amide Local Anesthetic; Catecholamine; alpha-Adrenergic Agonist; beta-Adrenergic Agonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N463323046157 followed by a unit qualifier and the quantity

Package 63323-0461-57. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Apr 30, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

SENSORCAINE / SENSORCAINE WITH EPINEPHRINE is indicated in adults 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. Specific concentrations and presentations of SENSORCAINE / SENSORCAINE WITH EPINEPHRINE are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration ( 2.2 )]. SENSORCAINE contains bupivacaine, an amide local anesthetic, and SENSORCAINE WITH EPINEPHRINE is a combination of bupivacaine, an amide local anesthetic, and epinephrine, an alpha and beta-adrenergic agonist. SENSORCAIN…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63323-461

What is NDC 63323-461?: 63323-461 is the product NDC for Sensorcaine, Bupivacaine hydrochloride 2.5 mg/mL; Epinephrine bitartrate .005 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Sensorcaine (BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE).
What is the active ingredient?: Bupivacaine hydrochloride, Epinephrine bitartrate.
Who is the labeler?: Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Sensorcaine?: 6 other product NDCs are listed under this name. See all Sensorcaine NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Sensorcaine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Sensorcainebupivacaine hydrochloride	Bupivacaine hydrochloride 2.5 mg/mL	Injection, SolutionInfiltration, Perineural	Henry Schein, Inc.	0404-9945	00404-9945-50
Sensorcainebupivacaine hydrochloride	Bupivacaine hydrochloride 5 mg/mL	Injection, SolutionPerineural	Henry Schein, Inc.	0404-9947	00404-9947-50
Sensorcainebupivacaine hydrochloride and epinephrine bitartrate	Bupivacaine hydrochloride 5 mg/mL; Epinephrine bitartrate .005 mg/mL	Injection, SolutionPerineural	Fresenius Kabi USA, LLC	63323-463	63323-0463-57
Sensorcainebupivacaine hydrochloride	Bupivacaine hydrochloride 2.5 mg/mL	Injection, SolutionInfiltration, Perineural	Fresenius Kabi USA, LLC	63323-465	63323-0465-57
Sensorcainebupivacaine hydrochloride	Bupivacaine hydrochloride 5 mg/mL	Injection, SolutionPerineural	Fresenius Kabi USA, LLC	63323-467	63323-0467-57
Sensorcainebupivacaine hydrochloride and epinephrine bitartrate	Bupivacaine hydrochloride 5 mg/mL; Epinephrine bitartrate .005 mg/mL	Injection, SolutionPerineural	Sportpharm LLC	85766-255	85766-0255-25

Other NDCs under ANDA 070967

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 070967
Product	Strength	Form · route	Labeler	Product NDC
Sensorcaine(R) (Bupivacaine Hci And Epinephrine)	Bupivacaine hydrochloride 2.5 mg/mL; Epinephrine bitartrate .005 mg/mL	Injection, SolutionInfiltration, Perineural	HF Acquisition Co LLC, DBA HealthFirst	51662-1397