FDA.reportPublic FDA data

Application 071165

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINEBUPIVACAINE HYDROCHLORIDE; EPINEPHRINEINJECTABLE;INJECTION0.25%;0.005MG/MLNoYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A071165-001BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINEBUPIVACAINE HYDROCHLORIDE; EPINEPHRINE0.25%;0.005MG/MLINJECTABLE / INJECTIONRS1988-06-16

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A071165-001BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE0.25%;0.005MG/MLINJECTABLE / INJECTIONRS1988-06-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071165-001BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE0.25%;0.005MG/MLINJECTABLE / INJECTIONRS1988-06-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A071165-001BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE0.25%;0.005MG/MLINJECTABLE / INJECTIONRS1988-06-16cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A071165-001BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE0.25%;0.005MG/MLINJECTABLE / INJECTIONRS1988-06-16a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEHospira, Inc.02a845c3-4521-4926-e397-25ab536e7cf62026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071165
application number: ANDA071165
ndc (product): 0409-9042

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9828Bupivacaine Hydrochloride and EpinephrineBupivacaine Hydrochloride and EpinephrineHenry Schein, Inc.ANDACurrent
0409-9042BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINEbupivacaine hydrochloride and epinephrineHospira, Inc.ANDACurrent
0409-9042Bupivacaine Hydrochloride and EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINEHospira, Inc.ANDACurrent
0409-9042Bupivacaine Hydrochloride and EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINEHospira, Inc.ANDACurrent
0409-9042BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINEbupivacaine hydrochloride and epinephrineHospira, Inc.ANDACurrent
0409-9042Bupivacaine Hydrochloride and EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINEHospira, Inc.ANDACurrent
0409-9042BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINEbupivacaine hydrochloride and epinephrineHospira, Inc.ANDACurrent
0409-9042BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINEbupivacaine hydrochloride and epinephrineHospira, Inc.ANDACurrent
0409-9042Bupivacaine Hydrochloride and EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINEHospira, Inc.ANDACurrent
0409-9042BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINEbupivacaine hydrochloride and epinephrineHospira, Inc.ANDACurrent
0409-9042Bupivacaine Hydrochloride and EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINEHospira, Inc.ANDACurrent
0409-9042BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINEbupivacaine hydrochloride and epinephrineHospira, Inc.ANDACurrent
0409-9042Bupivacaine Hydrochloride and EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINEHospira, Inc.ANDACurrent
0409-9042Bupivacaine Hydrochloride and EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINEHospira, Inc.ANDACurrent
52584-042Bupivacaine Hydrochloride and EpinephrineBupivacaine Hydrochloride and EpinephrineGeneral Injectables & Vaccines, IncANDACurrent
52584-042Bupivacaine Hydrochloride and EpinephrineBupivacaine Hydrochloride and EpinephrineGeneral Injectables & Vaccines, IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18342SUPPL2010-02-22