NDC 63323-461

SENSORCAINE

Bupivacaine Hydrochloride And Epinephrine Bitartrate

SENSORCAINE is a Infiltration; Perineural Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Bupivacaine Hydrochloride; Epinephrine Bitartrate.

• Product ID: 63323-461_8dd36777-022a-21b9-e053-2a95a90a1fe6
• NDC: 63323-461
• Product Type: Human Prescription Drug
• Proprietary Name: SENSORCAINE
• Generic Name: Bupivacaine Hydrochloride And Epinephrine Bitartrate
• Dosage Form: Injection, Solution
• Route of Administration: INFILTRATION; PERINEURAL
• Marketing Start Date: 2010-11-19
• Marketing Category: ANDA / ANDA
• Application Number: ANDA070967
• Labeler Name: Fresenius Kabi USA, LLC
• Substance Name: BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
• Active Ingredient Strength: 3 mg/mL; mg/mL
• Pharm Classes: Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 63323-461-57

25 VIAL, MULTI-DOSE in 1 TRAY (63323-461-57) > 50 mL in 1 VIAL, MULTI-DOSE (63323-461-01)

• Marketing Start Date: 2010-11-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63323-461-57 [63323046157]

SENSORCAINE INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA070967
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2010-11-19

NDC 63323-461-01 [63323046101]

SENSORCAINE INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA070967
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-16

NDC 63323-461-50 [63323046150]

SENSORCAINE INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA070967
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-11-19
• Marketing End Date: 2011-07-14

Drug Details

Active Ingredients

Ingredient	Strength
BUPIVACAINE HYDROCHLORIDE	2.5 mg/mL

OpenFDA Data

• SPL SET ID: bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb
• Manufacturer:
  • Fresenius Kabi USA, LLC
• UNII:
  • 7TQO7W3VT8
  • 30Q7KI53AK
• RxNorm Concept Unique ID - RxCUI:
  • 1867596
  • 1724810
  • 1867594
  • 1867620
  • 1012413
  • 1724809
  • 1012417
  • 1012377
  • 1867618
  • 1724786
  • 1724787
  • 1012384
• UPC Code:
  • 0363323468378
  • 0363323463571

Pharmacological Class

• Amide Local Anesthetic [EPC]
• Amides [CS]
• Local Anesthesia [PE]
• Adrenergic alpha-Agonists [MoA]
• Adrenergic beta-Agonists [MoA]
• alpha-Adrenergic Agonist [EPC]
• beta-Adrenergic Agonist [EPC]
• Catecholamine [EPC]
• Catecholamines [CS]

NDC Crossover Matching brand name "SENSORCAINE" or generic name "Bupivacaine Hydrochloride And Epinephrine Bitartrate"

NDC	Brand Name	Generic Name
0404-9945	Sensorcaine	Bupivacaine Hydrochloride
0404-9947	Sensorcaine	Bupivacaine Hydrochloride
52584-465	Sensorcaine	Bupivacaine Hydrochloride
52584-467	Sensorcaine	Sensorcaine
63323-463	SENSORCAINE	SENSORCAINE
63323-461	SENSORCAINE	SENSORCAINE
63323-465	SENSORCAINE	SENSORCAINE
63323-467	SENSORCAINE	SENSORCAINE
0362-0557	Marcaine	bupivacaine hydrochloride and epinephrine bitartrate
31382-557	Marcaine	bupivacaine hydrochloride and epinephrine bitartrate
0404-9908	MARCAINE WITH EPINEPHRINE	bupivacaine hydrochloride and epinephrine bitartrate
0409-1746	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE
0409-1749	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE
0409-1752	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE
0409-1755	Marcaine with Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE
0362-9011	Vivacaine	bupivacaine hydrochloride and epinephrine bitartrate