Application 080408

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREELIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION1%NoNo
002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREELIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION1.5%NoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREELIDOCAINE HYDROCHLORIDE1%INJECTABLE / INJECTIONAPApproved before 1982
A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREELIDOCAINE HYDROCHLORIDE1.5%INJECTABLE / INJECTIONAPApproved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A080408-001AP
A080408-002AP

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 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1.5%INJECTABLE / INJECTIONAPApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1.5%INJECTABLE / INJECTIONAPApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1.5%INJECTABLE / INJECTIONAPApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1.5%INJECTABLE / INJECTIONAPApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1.5%INJECTABLE / INJECTIONAPApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1.5%INJECTABLE / INJECTIONAPApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1.5%INJECTABLE / INJECTIONAPApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1.5%INJECTABLE / INJECTIONAPApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1.5%INJECTABLE / INJECTIONAPApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1.5%INJECTABLE / INJECTIONAPApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1.5%INJECTABLE / INJECTIONAPApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1.5%INJECTABLE / INJECTIONAPApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1.5%INJECTABLE / INJECTIONAPApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1.5%INJECTABLE / INJECTIONAPApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1.5%INJECTABLE / INJECTIONAPApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1.5%INJECTABLE / INJECTIONAPApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1.5%INJECTABLE / INJECTIONAPApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1.5%INJECTABLE / INJECTIONAPApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1.5%INJECTABLE / INJECTIONAPApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A080408-001LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1%INJECTABLE / INJECTIONAPApproved before 1982782e0a99824c…
2021-12-28 21:50 UTC2021-12A080408-002LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE1.5%INJECTABLE / INJECTIONAPApproved before 1982782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A080408-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A080408-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080408-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080408-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A080408-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A080408-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080408-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080408-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080408-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080408-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080408-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080408-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080408-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080408-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080408-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080408-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080408-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080408-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A080408-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A080408-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080408-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080408-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080408-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080408-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A080408-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A080408-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A080408-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A080408-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080408-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080408-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A080408-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A080408-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A080408-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A080408-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A080408-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A080408-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A080408-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A080408-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A080408-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A080408-002AP1782e0a99824c…

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 · 4 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): 080408
application number: ANDA080408
ndc (product): 0409-4713
ndc (product): 0409-4776
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDE ANHYDROUSHenry Schein, Inc.a5d4b206-cc53-470f-9bca-abfc6ea5cc992025-09-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080408
application number: ANDA080408
ndc (product): 0404-9887
LIDOCAINE HClLIDOCAINE HCLHF Acquisition Co LLC, DBA HealthFirste39435a3-1f69-78c5-e053-2995a90a7fc32024-01-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080408
application number: ANDA080408
ndc (product): 51662-1593
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEAsclemed USA, Inc.deec52c7-ebcf-422e-beab-bc1df2fe30cb2022-10-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080408
application number: ANDA080408
ndc (product): 76420-084

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9887Lidocaine HydrochlorideLidocaine Hydrochloride AnhydrousHenry Schein, Inc.ANDACurrent
0404-9887Lidocaine HydrochlorideLidocaine Hydrochloride AnhydrousHenry Schein, Inc.ANDACurrent
0409-4713Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4713Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4713Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4713Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4713Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4713Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4713Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4713Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4713Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4713Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4713Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4713Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4713Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4776Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4776Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4776Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4776Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4776Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4776Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4776Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4776Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4776Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4776Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4776Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4776Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4776Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
51662-1593LIDOCAINE HClLIDOCAINE HClHF Acquisition Co LLC, DBA HealthFirstANDACurrent
52584-713Lidocaine HydrochlorideLidocaine Hydrochloride AnhydrousGeneral Injectables & Vaccines, IncANDACurrent
52584-713Lidocaine HydrochlorideLidocaine Hydrochloride AnhydrousGeneral Injectables & Vaccines, IncANDACurrent
52584-713Lidocaine HydrochlorideLidocaine Hydrochloride AnhydrousGeneral Injectables & Vaccines, IncANDACurrent
52584-713Lidocaine HydrochlorideLidocaine Hydrochloride AnhydrousGeneral Injectables & Vaccines, IncANDACurrent
52584-713Lidocaine HydrochlorideLidocaine Hydrochloride AnhydrousGeneral Injectables & Vaccines, IncANDACurrent
53225-3800ReadySharp LidocaineLIDOCAINE HYDROCHLORIDETerrain PharmaceuticalsANDACurrent
53225-3800ReadySharp LidocaineLIDOCAINE HYDROCHLORIDETerrain PharmaceuticalsANDACurrent
53225-3800ReadySharp LidocaineLIDOCAINE HYDROCHLORIDETerrain PharmaceuticalsANDACurrent
53225-3800ReadySharp LidocaineLIDOCAINE HYDROCHLORIDETerrain PharmaceuticalsANDACurrent
55154-3187Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDE ANHYDROUSCardinal HealthANDACurrent
55154-3187Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDE ANHYDROUSCardinal HealthANDACurrent
76420-084Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEAsclemed USA, Inc.ANDACurrent
76420-084Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEAsclemed USA, Inc.ANDACurrent