NDC 65250-266

EXPAREL

Bupivacaine

EXPAREL is a Infiltration Injection, Suspension, Liposomal in the Human Prescription Drug category. It is labeled and distributed by Pacira Pharmaceuticals Inc.. The primary component is Bupivacaine.

• Product ID: 65250-266_23030401-c18b-4366-b87d-addbe252269b
• NDC: 65250-266
• Product Type: Human Prescription Drug
• Proprietary Name: EXPAREL
• Generic Name: Bupivacaine
• Dosage Form: Injection, Suspension, Liposomal
• Route of Administration: INFILTRATION
• Marketing Start Date: 2012-01-01
• Marketing Category: NDA / NDA
• Application Number: NDA022496
• Labeler Name: Pacira Pharmaceuticals Inc.
• Substance Name: BUPIVACAINE
• Active Ingredient Strength: 13 mg/mL
• Pharm Classes: Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 65250-266-04

4 VIAL in 1 CARTON (65250-266-04) > 20 mL in 1 VIAL (65250-266-20)

• Marketing Start Date: 2016-09-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65250-266-04 [65250026604]

EXPAREL INJECTION, SUSPENSION, LIPOSOMAL

• Marketing Category: NDA
• Application Number: NDA022496
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-09-28

NDC 65250-266-20 [65250026620]

EXPAREL INJECTION, SUSPENSION, LIPOSOMAL

• Marketing Category: NDA
• Application Number: NDA022496
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2012-01-01

NDC 65250-266-09 [65250026609]

EXPAREL INJECTION, SUSPENSION, LIPOSOMAL

• Marketing Category: NDA
• Application Number: NDA022496
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-03-31

Drug Details

Active Ingredients

Ingredient	Strength
BUPIVACAINE	13.3 mg/mL

OpenFDA Data

• SPL SET ID: bb5a9e59-0f51-11df-8a39-0800200c9a66
• Manufacturer:
  • Pacira Pharmaceuticals Inc.
• UNII:
  • Y8335394RO
• RxNorm Concept Unique ID - RxCUI:
  • 1191513
  • 1745062
  • 1191508
  • 1745061

Pharmacological Class

• Amide Local Anesthetic [EPC]
• Amides [CS]
• Local Anesthesia [PE]

NDC Crossover Matching brand name "EXPAREL" or generic name "Bupivacaine"

NDC	Brand Name	Generic Name
65250-133	EXPAREL	bupivacaine
65250-266	EXPAREL	bupivacaine
49396-6601	POSIMIR	Bupivacaine
51715-660	POSIMIR	bupivacaine