Application 019830

Type
NDA
Sponsor
B BRAUN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
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 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019830-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINERLIDOCAINE HYDROCHLORIDE200MG/100MLINJECTABLE / INJECTIONAP1992-04-08
N019830-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINERLIDOCAINE HYDROCHLORIDE400MG/100MLINJECTABLE / INJECTIONAP1992-04-08
N019830-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINERLIDOCAINE HYDROCHLORIDE800MG/100MLINJECTABLE / INJECTIONAP1992-04-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N019830-002AP
N019830-003AP
N019830-004AP

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 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N019830-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP1992-04-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019830-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAP1992-04-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019830-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1992-04-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019830-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP1992-04-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019830-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAP1992-04-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019830-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1992-04-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N019830-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP1992-04-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019830-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAP1992-04-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019830-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1992-04-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019830-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP1992-04-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019830-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAP1992-04-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019830-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1992-04-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019830-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP1992-04-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019830-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAP1992-04-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019830-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1992-04-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019830-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP1992-04-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019830-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAP1992-04-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019830-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1992-04-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019830-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP1992-04-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019830-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAP1992-04-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019830-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1992-04-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019830-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP1992-04-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019830-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAP1992-04-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019830-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1992-04-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019830-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP1992-04-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019830-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAP1992-04-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019830-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1992-04-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019830-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP1992-04-08d06236e962d9…
2024-10-29 15:01 UTC2024-10N019830-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAP1992-04-08d06236e962d9…
2024-10-29 15:01 UTC2024-10N019830-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1992-04-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019830-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP1992-04-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019830-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAP1992-04-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019830-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1992-04-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019830-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP1992-04-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019830-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAP1992-04-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019830-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1992-04-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019830-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP1992-04-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019830-003LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER400MG/100MLINJECTABLE / INJECTIONAP1992-04-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019830-004LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER800MG/100MLINJECTABLE / INJECTIONAP1992-04-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019830-002LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP1992-04-088072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N019830-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019830-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019830-004AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019830-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019830-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019830-004AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019830-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019830-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019830-004AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019830-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019830-003AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019830-004AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019830-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019830-003AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019830-004AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019830-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019830-003AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019830-004AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019830-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019830-003AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019830-004AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019830-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019830-003AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019830-004AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019830-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019830-003AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019830-004AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019830-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N019830-003AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N019830-004AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019830-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019830-003AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019830-004AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019830-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019830-003AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019830-004AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019830-002AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019830-003AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019830-004AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019830-002AP18072bd15b7f6…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine Hydrochloride and DextroseLIDOCAINE HYDROCHLORIDE ANHYDROUS AND DEXTROSE MONOHYDRATEProPharma Distribution48c0ee87-f722-1a71-e063-6394a90a72d12026-01-19Warnings, Adverse reactionsExact identifier
application applno (NDA): 019830
application number: NDA019830
Lidocaine Hydrochloride and DextroseLIDOCAINE HYDROCHLORIDE ANHYDROUS AND DEXTROSE MONOHYDRATEB. Braun Medical Inc.7dff29d9-522d-40eb-a9d9-42377912d6402026-01-14Warnings, Adverse reactionsExact identifier
application applno (NDA): 019830
application number: NDA019830
ndc (product): 0264-9598
ndc (product): 0264-9594
LIDOCAINE HCI AND DEXTROSELIDOCAINE HCI AND DEXTROSEHF Acquisition Co LLC, DBA HealthFirstc75311e3-ca6e-40de-e053-2a95a90a1bda2021-07-17Warnings, Adverse reactionsExact identifier
application applno (NDA): 019830
application number: NDA019830
ndc (product): 51662-1565

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0264-9594Lidocaine Hydrochloride and DextroseLIDOCAINE HYDROCHLORIDE ANHYDROUS and DEXTROSE MONOHYDRATEB. Braun Medical Inc.NDACurrent
0264-9594Lidocaine Hydrochloride and DextroseLIDOCAINE HYDROCHLORIDE ANHYDROUS and DEXTROSE MONOHYDRATEB. Braun Medical Inc.NDACurrent
0264-9598Lidocaine Hydrochloride and DextroseLIDOCAINE HYDROCHLORIDE ANHYDROUS and DEXTROSE MONOHYDRATEB. Braun Medical Inc.NDACurrent
0264-9598Lidocaine Hydrochloride and DextroseLIDOCAINE HYDROCHLORIDE ANHYDROUS and DEXTROSE MONOHYDRATEB. Braun Medical Inc.NDACurrent
50090-4555Lidocaine Hydrochloride and DextroseLIDOCAINE HYDROCHLORIDE ANHYDROUS and DEXTROSE MONOHYDRATEA-S Medication SolutionsNDACurrent
50090-4559Lidocaine Hydrochloride and DextroseLIDOCAINE HYDROCHLORIDE ANHYDROUS and DEXTROSE MONOHYDRATEA-S Medication SolutionsNDACurrent
51662-1565LIDOCAINE HCI AND DEXTROSELIDOCAINE HCI AND DEXTROSEHF Acquisition Co LLC, DBA HealthFirstNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
63164SUPPL2020-05-20
63154SUPPL2020-05-20
33996SUPPL2013-02-06
1658SUPPL2013-02-04
19271SUPPL2004-06-25