exparel

Generic: bupivacaine

Labeler: pacira pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name exparel
Generic Name bupivacaine
Labeler pacira pharmaceuticals, inc.
Dosage Form INJECTION, SUSPENSION, LIPOSOMAL
Routes
INFILTRATION
Active Ingredients

bupivacaine 13.3 mg/mL

Manufacturer
Pacira Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 65250-133
Product ID 65250-133_7dd52279-ea2e-4f8c-8e29-8172bc3ed882
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022496
Listing Expiration 2026-12-31
Marketing Start 2016-01-01

Pharmacologic Class

Established (EPC)
amide local anesthetic [epc]
Chemical Structure
amides [cs]
Physiologic Effect
local anesthesia [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65250133
Hyphenated Format 65250-133

Supplemental Identifiers

RxCUI
1191508 1191513 1745061 1745062
UNII
Y8335394RO
NUI
N0000175682 M0000897 N0000175976

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name exparel (source: ndc)
Generic Name bupivacaine (source: ndc)
Application Number NDA022496 (source: ndc)
Routes
INFILTRATION
source: ndc

Resolved Composition

Strengths
  • 13.3 mg/mL
source: ndc
Packaging
  • 4 VIAL in 1 CARTON (65250-133-04) / 10 mL in 1 VIAL (65250-133-10)
  • 10 VIAL in 1 CARTON (65250-133-09) / 10 mL in 1 VIAL (65250-133-10)
source: ndc

Packages (2)

65250-133-04 4 VIAL in 1 CARTON (65250-133-04) / 10 mL in 1 VIAL (65250-133-10) 65250-133-09 10 VIAL in 1 CARTON (65250-133-09) / 10 mL in 1 VIAL (65250-133-10)

Ingredients (1)

bupivacaine (13.3 mg/mL)

Linked Drug Pages (1)

EXPAREL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INFILTRATION"], "spl_id": "7dd52279-ea2e-4f8c-8e29-8172bc3ed882", "openfda": {"nui": ["N0000175682", "M0000897", "N0000175976"], "unii": ["Y8335394RO"], "rxcui": ["1191508", "1191513", "1745061", "1745062"], "spl_set_id": ["bb5a9e59-0f51-11df-8a39-0800200c9a66"], "pharm_class_cs": ["Amides [CS]"], "pharm_class_pe": ["Local Anesthesia [PE]"], "pharm_class_epc": ["Amide Local Anesthetic [EPC]"], "manufacturer_name": ["Pacira Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 VIAL in 1 CARTON (65250-133-04)  / 10 mL in 1 VIAL (65250-133-10)", "package_ndc": "65250-133-04", "marketing_start_date": "20160902"}, {"sample": false, "description": "10 VIAL in 1 CARTON (65250-133-09)  / 10 mL in 1 VIAL (65250-133-10)", "package_ndc": "65250-133-09", "marketing_start_date": "20160902"}], "brand_name": "EXPAREL", "product_id": "65250-133_7dd52279-ea2e-4f8c-8e29-8172bc3ed882", "dosage_form": "INJECTION, SUSPENSION, LIPOSOMAL", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "65250-133", "generic_name": "bupivacaine", "labeler_name": "Pacira Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "EXPAREL", "active_ingredients": [{"name": "BUPIVACAINE", "strength": "13.3 mg/mL"}], "application_number": "NDA022496", "marketing_category": "NDA", "marketing_start_date": "20160101", "listing_expiration_date": "20261231"}