Application 018461

Type
NDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINERLIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION100MG/100MLNoNo
002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINERLIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION200MG/100MLNoNo
003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINERLIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION400MG/100MLNoNo
004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINERLIDOCAINE HYDROCHLORIDEINJECTABLE;INJECTION800MG/100MLNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018461-001LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINERLIDOCAINE HYDROCHLORIDE100MG/100MLINJECTABLE / INJECTIONApproved before 1982
N018461-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINERLIDOCAINE HYDROCHLORIDE200MG/100MLINJECTABLE / INJECTIONAPApproved before 1982
N018461-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINERLIDOCAINE HYDROCHLORIDE400MG/100MLINJECTABLE / INJECTIONAPApproved before 1982
N018461-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINERLIDOCAINE HYDROCHLORIDE800MG/100MLINJECTABLE / INJECTIONAP1982-02-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N018461-002AP
N018461-003AP
N018461-004AP

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 3 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2019-12-13 00:20 UTC2019-12N018461-001LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER100MG/100MLINJECTABLE / INJECTIONApproved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N018461-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAPApproved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N018461-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAPApproved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N018461-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1982-02-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018461-001LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER100MG/100MLINJECTABLE / INJECTIONApproved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N018461-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAPApproved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N018461-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAPApproved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N018461-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1982-02-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018461-001LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER100MG/100MLINJECTABLE / INJECTIONApproved before 1982782e0a99824c…
2021-12-28 21:50 UTC2021-12N018461-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAPApproved before 1982782e0a99824c…
2021-12-28 21:50 UTC2021-12N018461-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAPApproved before 1982782e0a99824c…
2021-12-28 21:50 UTC2021-12N018461-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1982-02-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018461-001LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER100MG/100MLINJECTABLE / INJECTIONApproved before 198287673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018461-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAPApproved before 198287673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018461-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAPApproved before 198287673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018461-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1982-02-2287673890dc5c…
2021-03-12 10:30 UTC2021-03N018461-001LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER100MG/100MLINJECTABLE / INJECTIONApproved before 19825aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N018461-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAPApproved before 19825aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N018461-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAPApproved before 19825aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N018461-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1982-02-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018461-001LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER100MG/100MLINJECTABLE / INJECTIONApproved before 19828869cabd3fbd…
2020-12-22 03:56 UTC2020-12N018461-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAPApproved before 19828869cabd3fbd…
2020-12-22 03:56 UTC2020-12N018461-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAPApproved before 19828869cabd3fbd…
2020-12-22 03:56 UTC2020-12N018461-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1982-02-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018461-001LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER100MG/100MLINJECTABLE / INJECTIONApproved before 1982c0c555d07b60…
2020-11-12 02:37 UTC2020-11N018461-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAPApproved before 1982c0c555d07b60…
2020-11-12 02:37 UTC2020-11N018461-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAPApproved before 1982c0c555d07b60…
2020-11-12 02:37 UTC2020-11N018461-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1982-02-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018461-001LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER100MG/100MLINJECTABLE / INJECTIONApproved before 19823f01610625f2…
2019-12-14 00:12 UTC2019-12N018461-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAPApproved before 19823f01610625f2…
2019-12-14 00:12 UTC2019-12N018461-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAPApproved before 19823f01610625f2…
2019-12-14 00:12 UTC2019-12N018461-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1982-02-223f01610625f2…
2019-09-15 20:21 UTC2019-09N018461-001LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER100MG/100MLINJECTABLE / INJECTIONApproved before 1982b00525d2431f…
2019-09-15 20:21 UTC2019-09N018461-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAPApproved before 1982b00525d2431f…
2019-09-15 20:21 UTC2019-09N018461-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAPApproved before 1982b00525d2431f…
2019-09-15 20:21 UTC2019-09N018461-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1982-02-22b00525d2431f…
2019-07-19 19:46 UTC2019-07N018461-001LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER100MG/100MLINJECTABLE / INJECTIONApproved before 1982ea99ee380514…
2019-07-19 19:46 UTC2019-07N018461-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAPApproved before 1982ea99ee380514…
2019-07-19 19:46 UTC2019-07N018461-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAPApproved before 1982ea99ee380514…
2019-07-19 19:46 UTC2019-07N018461-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1982-02-22ea99ee380514…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09N018461-002AP1c2088c7a36db…
2026-10-15 13:18:302026-09N018461-003AP1c2088c7a36db…
2026-10-15 13:18:302026-09N018461-004AP1c2088c7a36db…
2026-09-14 22:38:342026-08N018461-002AP184e616aacf4f…
2026-09-14 22:38:342026-08N018461-003AP184e616aacf4f…
2026-09-14 22:38:342026-08N018461-004AP184e616aacf4f…
2026-08-18 06:07:402026-07N018461-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N018461-003AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N018461-004AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018461-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018461-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018461-004AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018461-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018461-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018461-004AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018461-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018461-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018461-004AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018461-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018461-003AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018461-004AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018461-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018461-003AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018461-004AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018461-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018461-003AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018461-004AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018461-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018461-003AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018461-004AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018461-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018461-003AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018461-004AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018461-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018461-003AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018461-004AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018461-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018461-003AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018461-004AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018461-002AP179d66fd596c7…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine Hydrochloride and DextroseLIDOCAINE HYDROCHLORIDEBaxter Healthcare Corporationf21512ea-c7c3-4766-b976-b2c0b5616bf02026-02-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 018461
application number: NDA018461
ndc (product): 0338-0409
ndc (product): 0338-0411
LIDOCAINE HYDROCHLORIDE AND DEXTROSELIDOCAINE HYDROCHLORIDE AND DEXTROSEHF Acquisition Co LLC, DBA HealthFirst1bf999b5-e290-dcbd-e063-6294a90a2bab2026-01-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 018461
application number: NDA018461

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 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0338-0409Lidocaine Hydrochloride and DextroseLidocaine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-0409Lidocaine Hydrochloride and DextroseLidocaine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-0409Lidocaine Hydrochloride and DextroseLidocaine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-0409Lidocaine Hydrochloride and DextroseLidocaine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-0409Lidocaine Hydrochloride and DextroseLidocaine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-0411Lidocaine Hydrochloride and DextroseLidocaine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-0411Lidocaine Hydrochloride and DextroseLidocaine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-0411Lidocaine Hydrochloride and DextroseLidocaine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-0411Lidocaine Hydrochloride and DextroseLidocaine HydrochlorideBaxter Healthcare CorporationNDACurrent
0338-0411Lidocaine Hydrochloride and DextroseLidocaine HydrochlorideBaxter Healthcare CorporationNDACurrent
51662-1302LIDOCAINE HCI AND DEXTROSELIDOCAINE HCI AND DEXTROSEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1302LIDOCAINE HCI AND DEXTROSELIDOCAINE HCI AND DEXTROSEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1302LIDOCAINE HCI AND DEXTROSELIDOCAINE HCI AND DEXTROSEHF Acquisition Co LLC, DBA HealthFirstNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
47243SUPPL2017-02-16
47133SUPPL2017-02-08
15010SUPPL2012-03-12
33493SUPPL2012-03-05
15009SUPPL2012-02-29
926SUPPL2003-12-16
40800SUPPL2002-09-10
15008SUPPL2002-01-23
11223SUPPL2002-01-23