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 4 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018461-001LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER100MG/100MLINJECTABLE / INJECTIONApproved before 19826a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018461-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAPApproved before 19826a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018461-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAPApproved before 19826a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018461-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1982-02-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018461-001LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER100MG/100MLINJECTABLE / INJECTIONApproved before 19821c564ffb4f44…
2024-02-18 07:12 UTC2024-02N018461-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAPApproved before 19821c564ffb4f44…
2024-02-18 07:12 UTC2024-02N018461-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAPApproved before 19821c564ffb4f44…
2024-02-18 07:12 UTC2024-02N018461-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1982-02-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018461-001LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER100MG/100MLINJECTABLE / INJECTIONApproved before 1982ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N018461-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAPApproved before 1982ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N018461-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAPApproved before 1982ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N018461-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1982-02-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018461-001LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER100MG/100MLINJECTABLE / INJECTIONApproved before 1982a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018461-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAPApproved before 1982a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018461-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAPApproved before 1982a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018461-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1982-02-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018461-001LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER100MG/100MLINJECTABLE / INJECTIONApproved before 19829b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018461-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAPApproved before 19829b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018461-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAPApproved before 19829b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018461-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1982-02-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018461-001LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER100MG/100MLINJECTABLE / INJECTIONApproved before 1982a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018461-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAPApproved before 1982a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018461-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAPApproved before 1982a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018461-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1982-02-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018461-001LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER100MG/100MLINJECTABLE / INJECTIONApproved before 19823f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018461-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAPApproved before 19823f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018461-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAPApproved before 19823f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018461-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1982-02-223f0d92c62455…
2023-05-13 08:27 UTC2023-05N018461-001LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER100MG/100MLINJECTABLE / INJECTIONApproved before 1982053a50430f4f…
2023-05-13 08:27 UTC2023-05N018461-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAPApproved before 1982053a50430f4f…
2023-05-13 08:27 UTC2023-05N018461-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAPApproved before 1982053a50430f4f…
2023-05-13 08:27 UTC2023-05N018461-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1982-02-22053a50430f4f…
2023-01-26 05:58 UTC2023-01N018461-001LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER100MG/100MLINJECTABLE / INJECTIONApproved before 19823bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N018461-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAPApproved before 19823bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N018461-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAPApproved before 19823bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N018461-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1982-02-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018461-001LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER100MG/100MLINJECTABLE / INJECTIONApproved before 19823a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018461-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAPApproved before 19823a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018461-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAPApproved before 19823a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018461-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1982-02-223a93d1ddd44b…

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