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 2 of 5 · 84 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupivilog KitMARCAINE, KENALOG, POVIDONE IODINEAsclemed USA, Inc.9d485952-e8f5-4ec9-bab2-6ee4217e807a2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1724880
Dexlido-M KitDEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, MARICAINE, POVIDINE IODINEAsclemed USA, Inc.d3fd1d51-7749-4e1e-a8b5-8a151392f66d2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1725078
Mardex 25 KitDEXAMETHASONE SODIUM PHOSPHATE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINEAsclemed USA, Inc.94472ddb-ae1d-4a11-a673-81254d562e6b2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1725078
rxcui: 1725082
MLK F4 KitTRIAMCINOLONE ACETONIDE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINEAsclemed USA, Inc.829e3bd1-fb1c-4613-9db3-9a89ef8e2c0c2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1724880
MLK F1 KitMARCAINE, LIDOCAINE, KENALOG, POVIDONE IODINEAsclemed USA, Inc.0cd42a2f-d202-447d-998e-8877ac3c0d382026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1724880
Marlido 25 KitLIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINEAsclemed USA, Inc.1fe460e7-208d-410e-84c5-cd63005cff472026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1725078
MLK Kit F2MARCAINE, LIDOCAINE, KENALOG, POVIDONE IODINEAsclemed USA, Inc.08990ac8-3215-4b84-b2be-23298edbddf42026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1724880
Ketorocaine LM KitKETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINEAsclemed USA, Inc.35ffe071-8bc1-4c88-8c85-645847acf1692026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1725078
rxcui: 1725082
Marbeta L KitBETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOLAsclemed USA, Inc.9a6a3871-4e02-47f9-a20e-a256b3f3c4982026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1725078
MLK F3 KitMARCAINE, LIDOCAINE, KENALOG, POVIDONE IODINEAsclemed USA, Inc.481aeef5-01cb-4567-a67f-896e6929b2ed2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1724880
Dyural 80 KitMETHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOLAsclemed USA, Inc.e9f7f923-e7f9-4c52-b56d-914d800c1acf2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1725078
rxcui: 1725082
Dyural LM KitMETHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOLAsclemed USA, Inc.cdd72141-10b6-48c6-85be-5b1294c8539c2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1725078
rxcui: 1725082
BLT-25 KitBUPIVACAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE, TRIAMCINOLONE ACETONIDE, POVIDINE IODINEAsclemed USA, Inc.87307801-d970-41cf-ad1e-d89b0ff8549f2026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1725078
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEProPharma Distribution42c973e2-307b-924c-e063-6394a90a737a2025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1724884
unii: 7TQO7W3VT8
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEProPharma Distribution3f7ab295-6429-4760-e063-6294a90a781f2025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
bupivacaine hydrochlorideBUPIVACAINE HYDROCHLORIDENorthstar Rx LLCadadc041-8d5e-4bf8-a89b-e227729a880d2025-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
SensorcaineBUPIVACAINE HYDROCHLORIDEHenry Schein, Inc.2046d833-2974-42fd-a29e-7fc1dc7166cc2025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEONESOURCE SPECIALTY PHARMA LIMITED5c10e3a1-7806-40c7-afd2-4c420e1418232025-11-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA091487
rxcui: 1724880
rxcui: 1724884
rxcui: 1724787
rxcui: 1725078
rxcui: 1725082
rxcui: 1724786
unii: 7TQO7W3VT8
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEONESOURCE SPECIALTY PHARMA LIMITED02d0e5f1-5fab-4420-b673-785fd81d7ae22025-11-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
Sensorcaine MPFBUPIVACAINE HYDROCHLORIDEHenry Schein, Inc.78c6789d-773e-4b26-90bd-34a6b6d730ce2025-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1724880
unii: 7TQO7W3VT8

Reported adverse events (FAERS/openFDA)#

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