Application 088327

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINERLIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION2%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
A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINERLIDOCAINE HYDROCHLORIDE2%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
A088327-001AP

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-313f01610625f2…
2019-09-15 20:21 UTC2019-09A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A088327-001LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER2%INJECTABLE / INJECTIONAP1984-07-31cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A088327-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088327-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A088327-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088327-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088327-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088327-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088327-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088327-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088327-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088327-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088327-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088327-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088327-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088327-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088327-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088327-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088327-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088327-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088327-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088327-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088327-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A088327-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088327-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088327-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088327-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A088327-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A088327-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088327-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088327-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088327-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088327-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088327-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088327-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088327-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A088327-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A088327-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088327-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088327-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088327-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A088327-001AP1cb3db0bc1861…

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 · 7 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): 088327
application number: ANDA088327
ndc (product): 0409-4277
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEProPharma Distribution42d9e4cf-ca73-ec6d-e063-6394a90ae9372025-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088327
application number: ANDA088327
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDE ANHYDROUSHenry Schein, Inc.bb53bb10-bb36-4c9b-b632-71455615f9f32025-09-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088327
application number: ANDA088327
ndc (product): 0404-9895
1% LIDOCAINE HCI1% LIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirst999b1c7b-3495-926a-e053-2a95a90ab2062025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088327
application number: ANDA088327
ndc (product): 51662-1467
2% LIDOCAINE HCI2% LIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirst78d8fb0a-bfae-6599-e053-2991aa0a2e032024-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088327
application number: ANDA088327
ndc (product): 51662-1326
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC8968c61e-2686-0fe6-e053-2a95a90a15fa2023-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088327
application number: ANDA088327
ndc (product): 71872-7125
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC858f3faa-e56e-51f9-e053-2a91aa0aa7212023-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088327
application number: ANDA088327
ndc (product): 71872-7095

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 48 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9895Lidocaine HydrochlorideLidocaine Hydrochloride AnhydrousHenry Schein, Inc.ANDACurrent
0404-9895Lidocaine HydrochlorideLidocaine Hydrochloride AnhydrousHenry Schein, Inc.ANDACurrent
0409-4277Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4277Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4277Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4277Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4277Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4277Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4277Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4277Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4277Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4277Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4277Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4277Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-4277Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEHospira, Inc.ANDACurrent
51662-13262% LIDOCAINE HCI2% LIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-13262% LIDOCAINE HCI2% LIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-13262% LIDOCAINE HCI2% LIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-13262% LIDOCAINE HCI2% LIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-13262% LIDOCAINE HCI2% LIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-14672% LIDOCAINE HCI2% LIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-14672% LIDOCAINE HCI2% LIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirstANDACurrent
52584-277Lidocaine HydrochlorideLidocaine Hydrochloride AnhydrousGeneral Injectables & Vaccines, IncANDACurrent
52584-277Lidocaine HydrochlorideLidocaine Hydrochloride AnhydrousGeneral Injectables & Vaccines, IncANDACurrent
52584-277Lidocaine HydrochlorideLidocaine Hydrochloride AnhydrousGeneral Injectables & Vaccines, IncANDACurrent
52584-277Lidocaine HydrochlorideLidocaine Hydrochloride AnhydrousGeneral Injectables & Vaccines, IncANDACurrent
52584-277Lidocaine HydrochlorideLidocaine Hydrochloride AnhydrousGeneral Injectables & Vaccines, IncANDACurrent
52584-277Lidocaine HydrochlorideLidocaine Hydrochloride AnhydrousGeneral Injectables & Vaccines, IncANDACurrent
55154-2373Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDE ANHYDROUSCardinal HealthANDACurrent
55154-6969Lidocaine Hydrochloridelidocaine hydrochlorideCardinal HealthANDACurrent
55154-6992Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDE ANHYDROUSCardinal HealthANDACurrent
61699-4277Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDE ANHYDROUSUS MedSource, LLCANDACurrent
63739-470Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEMcKesson Corporation dba SKY PackagingANDACurrent
63739-470Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEMcKesson CorporationANDACurrent
70529-002Lidenzal 2%LIDOCAINE HYDROCHLORIDEIT3 Medical LLCANDACurrent
70529-002Lidenzal 2%LIDOCAINE HYDROCHLORIDEIT3 Medical LLCANDACurrent
70529-002Lidenzal 2%LIDOCAINE HYDROCHLORIDEIT3 Medical LLCANDACurrent
70529-016Fossaoprin SPG2Lidocaine hydrochloride, Bupivacaine hydrochlorideIT3 Medical LLCANDACurrent
70529-016Fossaoprin SPG2Lidocaine hydrochloride, Bupivacaine hydrochlorideIT3 Medical LLCANDACurrent
70529-016Fossaoprin SPG2Lidocaine hydrochloride, Bupivacaine hydrochlorideIT3 Medical LLCANDACurrent
70529-051H-PaxinLidocaine Hydrochloride, Bupivacaine Hydrochloride, Betamethasone Sodium Phosphate and Betamethasone AcetateIT3 Medical LLCANDACurrent
70529-051H-PaxinLidocaine Hydrochloride, Bupivacaine Hydrochloride, Betamethasone Sodium Phosphate and Betamethasone AcetateIT3 Medical LLCANDACurrent
70529-051H-PaxinLidocaine Hydrochloride, Bupivacaine Hydrochloride, Betamethasone Sodium Phosphate and Betamethasone AcetateIT3 Medical LLCANDACurrent
70529-124Prelidopine Pre-Operative SystemLIDOCAINE HYDROCHLORIDEIT3 Medical LLCANDACurrent
70529-124Prelidopine Pre-Operative SystemLIDOCAINE HYDROCHLORIDEIT3 Medical LLCANDACurrent
70529-124Prelidopine Pre-Operative SystemLIDOCAINE HYDROCHLORIDEIT3 Medical LLCANDACurrent
71872-7095Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLCANDACurrent
71872-7125Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLCANDACurrent