FDA.reportPublic FDA data

NDC 65250-133-10 - EXPAREL

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
65250-133
Requested NDC
65250-133-10
Package NDCs from labels
65250-133-10, 65250-133-09, 65250-133-04
Manufacturer
Pacira Pharmaceuticals, Inc.
Effective date
2025-12-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
EXPAREL - Pacira Pharmaceuticals, Inc.Pacira Pharmaceuticals, Inc.2025-12-12HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65250-133-04EXPAREL4 in 1 CARTONINJECTION, SUSPENSION, LIPOSOMAL432
65250-133-09EXPAREL10 in 1 CARTONINJECTION, SUSPENSION, LIPOSOMAL1032
65250-133-10EXPAREL10 mL in 1 VIALINJECTION, SUSPENSION, LIPOSOMAL1032

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65250-133EXPAREL (BUPIVACAINE) INJECTION, SUSPENSION, LIPOSOMAL [PACIRA PHARMACEUTICALS, INC.]31Current NDC, Legacy NDC, 3 package rows20241218_bb5a9e59-0f51-11df-8a39-0800200c9a66.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65250-133-04ML - Milliliter65250-13359eadd1e-1c8e-4e4c-ab11-4b802c104a2412017-03-06
65250-133-09ML - Milliliter65250-133205fe808-ba20-4b7f-a0da-d7615d7b4a2012017-03-06
65250-133-10ML - Milliliter65250-13346b1495f-d9ae-4308-a443-1ece37f2937512017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPIVACAINEACTIVE INGREDIENTY8335394ROEXPAREL (BUPIVACAINE) INJECTION, SUSPENSION, LIPOSOMAL [PACIRA PHARMACEUTICALS INC.]6
BUPIVACAINEACTIVE MOIETYY8335394ROEXPAREL (BUPIVACAINE) INJECTION, SUSPENSION, LIPOSOMAL [PACIRA PHARMACEUTICALS INC.]6

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZYNRELEFBUPIVACAINE AND MELOXICAMHeron Therapeutics, Inc.dab484a7-9353-43ba-9e74-7fab910c712b2026-04-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Y8335394RO
EXPARELBUPIVACAINEPacira Pharmaceuticals, Inc.bb5a9e59-0f51-11df-8a39-0800200c9a662025-12-12Warnings, Adverse reactionsExact identifier
application number: NDA022496
ndc (package): 65250-266-09
ndc (package): 65250-266-04
ndc (package): 65250-266-20
ndc (package): 65250-133-10
ndc (package): 65250-133-04
ndc (package): 65250-133-09
ndc (product): 65250-266
ndc (product): 65250-133
ndc11 (package): 65250013310
rxcui: 1191513
rxcui: 1745062
rxcui: 1191508
rxcui: 1745061
spl id: 7dd52279-ea2e-4f8c-8e29-8172bc3ed882
spl set id: bb5a9e59-0f51-11df-8a39-0800200c9a66
unii: Y8335394RO
BupivacaineBUPIVACAINEJiangsu Hengrui Pharmaceuticals Co., Ltd.0af296bb-1599-4b35-b66b-994924d3e8982024-07-09Warnings, Adverse reactionsExact identifier
rxcui: 1191508
rxcui: 1745061
unii: Y8335394RO

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.