FDA.reportPublic FDA data

NDC 70594-117-01 - Bupivacaine HCl

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
70594-117
Requested NDC
70594-117-01
Package NDCs from labels
70594-117-01, 70594-117-02
Manufacturer
Xellia Pharmaceuticals USA LLC
Effective date
2023-06-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Bupivacaine HCl - Xellia Pharmaceuticals USA LLCXellia Pharmaceuticals USA LLC2023-06-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70594-117-01Bupivacaine HCl10 mL in 1 VIALINJECTION, SOLUTION102
70594-117-02Bupivacaine HCl10 in 1 CARTONINJECTION, SOLUTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70594-117BUPIVACAINE HCL (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION BUPIVACAINE HCL (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION BUPIVACINE HCL (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [XELLIA PHARMACEUTICALS USA LLC]2Current NDC, 2 package rows20230622_f29c905e-9a55-446f-a89d-860ad9ade7ad.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70594-117-01ML - Milliliter70594-1172feb9562-35c1-4637-931e-9f2fbd531c6a12023-08-08
70594-117-02ML - Milliliter70594-11776e4c81c-6b22-4365-85ea-1c7bc2ea966112023-08-08

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 5 · 84 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SENSORCAINEBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATESportpharm LLC370f3e9f-5081-4b06-9cfb-de39f6bf6ca22026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDENorthStar RxLLCee3b5bbe-4013-4682-b6ee-db86e77880772026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1724880
rxcui: 1724884
rxcui: 1724787
rxcui: 1725078
rxcui: 1725082
rxcui: 1724786
unii: 7TQO7W3VT8
MarcaineBUPIVACAINE HYDROCHLORIDEHenry Schein, Inc.562f4499-f3b7-4d9e-b022-61172176c8832026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1725078
unii: 7TQO7W3VT8
MarcaineBUPIVACAINE HYDROCHLORIDEHenry Schein, Inc.2c6f9b85-e783-4ad4-a804-a0ff1a32ec2c2026-06-24Warnings, Adverse reactionsExact identifier
rxcui: 1724880
unii: 7TQO7W3VT8
Marcaine SpinalBUPIVACAINE HYDROCHLORIDE IN DEXTROSEHospira, Inc.9679cc05-2f8a-4e88-53b5-6e9122c8b8c02026-06-23Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
BUPIVACAINE HClBUPIVACAINE HCLHF Acquisition Co LLC, DBA HealthFirste391f807-7699-6d82-e053-2a95a90ab6412026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.67578b56-7540-487e-1fba-481255620e782026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1724880
rxcui: 1724884
rxcui: 1724787
rxcui: 1725078
rxcui: 1725082
rxcui: 1724786
unii: 7TQO7W3VT8
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDESportpharm LLC6f9ebeef-350a-495e-a0bf-c335ab48bf1c2026-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1725078
unii: 7TQO7W3VT8
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDECardinal Health 107, LLC8f8f4ece-de78-4c13-8d9f-c3bb7053019d2026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1725082
unii: 7TQO7W3VT8
BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDEHospira, Inc.bb44c7e1-d911-4788-908f-09b7b271969b2026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1725078
rxcui: 1725082
unii: 7TQO7W3VT8
Bupivacaine SpinalBUPIVACAINE HYDROCHLORIDE IN DEXTROSEHospira, Inc.7a8d2539-4422-4312-0298-207ef1a2948e2026-04-07Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDECamber Pharmaceuticals, Inc.0e552e3a-cf52-4d74-9381-6cc1b29b4c902026-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1724880
rxcui: 1724884
rxcui: 1724787
rxcui: 1725078
rxcui: 1725082
rxcui: 1724786
unii: 7TQO7W3VT8
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEHospira, Inc.02a845c3-4521-4926-e397-25ab536e7cf62026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1724880
rxcui: 1724884
rxcui: 1724787
rxcui: 1725078
rxcui: 1725082
rxcui: 1724786
unii: 7TQO7W3VT8
Marlido KitMARCAINE, LIDOCAINE, POVIDONE IODINEAdvanced Rx of Tennessee, LLC49ef92f6-54d0-3d47-e063-6394a90aacec2026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1724880
MARCAINE WITH EPINEPHRINEBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHenry Schein, Inc.d0d51133-882c-4f9e-ba1c-f037226305a12026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
MarcaineBUPIVACINE HYDROCHLORIDEHenry Schein, Inc.7d94e8e0-0d1e-4af3-973a-a480d7d517372026-01-26Warnings, Adverse reactionsExact identifier
rxcui: 1724884
unii: 7TQO7W3VT8
Marvona-25 SUIKBUPIVACAINE HYDROCHLORIDEAsclemed USA, Inc.cb71b757-057e-42d4-8a12-8fd8e69a91242026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEBrookfield Pharmaceuticals, LLC.e8b32972-6984-4f1c-e053-2995a90a32772026-01-13Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
Marbeta 25 KitBETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINEAsclemed USA, Inc.1c157964-1977-4617-9f01-76ca01fb0f8f2026-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1725078
Dyural 40 KitMETHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOLAsclemed USA, Inc.151ae26c-bd4e-4582-b67a-7b5baf4669532026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1725078
rxcui: 1725082

Reported adverse events (FAERS/openFDA)#

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