FDA.reportPublic FDA data

NDC 57884-3251-01 - Bupivacaine

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
57884-3251
Requested NDC
57884-3251-01
Package NDCs from labels
57884-3251-1, 57884-3251-01
Manufacturer
Jiangsu Hengrui Pharmaceuticals Co., Ltd. | Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Jinqiao Road Site) | Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Dongjin Road Site)
Effective date
2024-07-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
BupivacaineJiangsu Hengrui Pharmaceuticals Co., Ltd. | Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Jinqiao Road Site) | Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Dongjin Road Site)2024-07-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57884-3251-1Bupivacaine10 mL in 1 VIALINJECTION, SUSPENSION, LIPOSOMAL104
57884-3251-1Bupivacaine10 in 1 CARTONINJECTION, SUSPENSION, LIPOSOMAL104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57884-3251BUPIVACAINE INJECTION, SUSPENSION, LIPOSOMAL [JIANGSU HENGRUI PHARMACEUTICALS CO., LTD.]4Current NDC, 2 package rows20240711_0af296bb-1599-4b35-b66b-994924d3e898.zip

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
rxcui: 1191508
rxcui: 1745061
unii: Y8335394RO
BupivacaineBUPIVACAINEJiangsu Hengrui Pharmaceuticals Co., Ltd.0af296bb-1599-4b35-b66b-994924d3e8982024-07-09Warnings, Adverse reactionsExact identifier
application number: ANDA214348
ndc (package): 57884-3251-1
ndc (package): 57884-3252-1
ndc (product): 57884-3252
ndc (product): 57884-3251
ndc11 (package): 57884325101
rxcui: 1191508
rxcui: 1745061
spl id: 1c5d9dbb-0d16-6893-e063-6394a90ad989
spl set id: 0af296bb-1599-4b35-b66b-994924d3e898
unii: Y8335394RO

Reported adverse events (FAERS/openFDA)#

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