FDA.reportPublic FDA data

Application 088325

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINERLIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION0.5%NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A088325-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINERLIDOCAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAP1984-07-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A088325-001AP

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A088325-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER0.5%INJECTABLE / INJECTIONAP1984-07-31a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A088325-001AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.3b2dd84e-cee8-4e58-d494-395a65a353a02026-01-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088325
application number: ANDA088325
ndc (product): 0409-4275
LIDOCAINE HCILIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirst952ffcce-0ec4-61c9-e053-2995a90a84af2025-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088325
application number: ANDA088325
ndc (product): 51662-1416

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
0409-4275Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4275Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4275Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4275Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4275Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4275Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4275Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4275Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4275Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4275Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4275Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4275Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4275Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
51662-1416LIDOCAINE HCILIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1416LIDOCAINE HCILIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1416LIDOCAINE HCILIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirstANDACurrent